The European Union’s REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation aims to ensure high levels of human health and environmental protection, while also promoting alternatives to animal testing. REACH permits animal testing as a last resort only and imposes the 3Rs principle (Replacement, Reduction, and Refinement of animal testing). Nevertheless, the current regulatory practices still heavily rely on animal-based methods. This study underscores the scientific limitations of animal models and highlights the ethical and methodological burdens associated with their use. It synthesises the challenges and opportunities associated with integrating New Approach Methodologies (NAMs) into regulatory toxicity testing under REACH, as highlighted by various scientific experts. Key challenges identified include contradictory and inadequate legislative frameworks, slow and restrictive validation processes, low acceptance of NAMs by regulatory authorities, and legislative amendments expected to increase animal testing. To create a more flexible regulatory environment and advance the adoption of NAMs, there is a need for legislative reforms and increased collaboration between academia, industry and regulatory bodies. In this context, it is also necessary that more legal scholars begin to show interest in this field to help tackle the multidisciplinary challenges to non-animal testing for regulatory purposes. This article provides an introduction to the field of regulatory toxicology with a focus on the REACH framework from a legal perspective.

Since 1979, plastic companies have significantly expanded their markets. Evidence suggests that excessive plastic use in Ethiopia has exacerbated environmental pollution, contributing to a “quadruple crisis” involving climate change, biodiversity loss, pollution and public health and economic impacts. To address this, the Ethiopian government needs to establish effective plastic waste management strategies. Key future direction and recommendation include (1) Developing and enforcing national strategies, including a ban on many single-use plastics, for sustainable plastic waste management; (2) adopting international best practices and policies to move toward a zero-waste approach; (3) investing in a circular economy and plastic waste management systems; (4) strengthening policies through comprehensive legislation and extended producer responsibility frameworks; (5) establishing a council to integrate scientific research into policymaking; (6) promoting green technologies and innovations, such as plastic waste-to-energy and smart waste management; (7) engaging in global efforts to monitor hazardous chemicals in plastics and support transparency in a toxic-free circular economy to ensure the public’s right to information.

Decapod crustaceans, commonly utilised for pure or applied scientific research and commercial food production, have generally remained outside ethical debate. However, in the last decade many parts of the world have seen an increase in public interest in the welfare of decapod crustaceans and statutory legal protection has been introduced in several countries. Although still limited to a small number of countries and remaining relatively unharmonised, relevant legislation could be increasingly broadened to include decapods in further jurisdictions. Much existing legislation, originally intended for protecting terrestrial vertebrates during scientific study, might be unsuitable for aquatic invertebrates such as decapods. Indeed, precedence with many fish species and cephalopods suggests detail is lacking with respect to fundamental guidance. Therefore, similar inclusion of decapods into such legislation could make welfare or scientific goals more challenging to achieve unless relevant guidance is available, particularly to animal care practitioners. This horizon paper aims to summarise existing decapod legislation, and the considerations required should decapods be included in current conceptual frameworks and scientific legislation.

Russell and Burch’s 1959 original definitions of the 3Rs (replacement, reduction and refinement) are widely used today as standards for the ethical use of non-human animals in research, although they have a number of limitations. Authors and institutions around the world have addressed some of these, coming up in certain cases with more accurate, functional, and up-to-date definitions. However, not only do there still remain limitations needing to be addressed, but some that have been addressed resulted in discrepancies, contradictions, and general confusion as to how best apply the 3Rs in practice. In order to clarify the meaning of the 3Rs and enable more optimal implementation of these principles in animal experimentation, this article provides a theoretical discussion for revised definitions of the original 3Rs via examination of some of their main limitations and inconsistencies. First, we offer up the original definitions as presented in the context of Russell and Burch’s book The Principles of Humane Experimental Technique. Then, we examine the main limitations and present clear specifications and requirements for such revised definitions. After presenting our revised definitions, we conclude with various implications for animal welfare within the context of experimentation.

Primates are important species for biomedical research and ensuring their good welfare is critical for research translatability and ethical responsibility. Systematic animal welfare assessments can support continuous programme improvements and build institutional awareness of areas requiring more attention. A multi-facility, collaborative project aimed to develop and implement a novel primate welfare assessment tool (PWAT) for use with research macaques. PWAT development involved: establishing an internal focus group of primate subject matter experts, identifying animal welfare categories and descriptors based on literature review, developing a preliminary tool, beta-testing the tool to ensure practicality and final consensus on descriptors, finalising the tool in a database with semi-automated data analysis, and delivering the tool to 13 sites across four countries. The tool uses input- and outcome-based measures from six categories: physical, behavioural, training, environmental, procedural, and culture of care. The final tool has 133 descriptors weighted based upon welfare impact, and is split into three forms for ease of use (room level, site level, and personnel interviews). The PWAT was trialled across facilities in March and September 2022 for benchmarking current macaque behavioural management programmes. The tool successfully distinguished strengths and challenges at the facility level and across sites. Following this benchmarking, the tool is being applied semi-annually to assess and monitor progress in behavioural management programmes. The development process of the PWAT demonstrates that evidence-based assessment tools can be developed through collaboration and consensus building, which are important for uptake and applicability, and ultimately for promoting global improvements in research macaque welfare.

The first “R” from animal research ethics prescribes the replacement of animal experiments with animal-free alternatives. However, the question of when an animal-free method qualifies as an alternative to animal experiments remains unresolved.

Drawing lessons from another debate in which the word “alternative” is central, the ethical debate on alternatives to germline genome editing, this paper develops a general account of when something qualifies as an alternative to something. It proposes three ethically significant conditions that technique, method, or approach X must meet to qualify as an alternative to Y: (1) X must address the same problem as Y, under an appropriate description of that problem; (2) X must have a reasonable chance of success, compared to Y, in solving the problem; and (3) X must not be ethically unacceptable as a solution. If X meets all these conditions, its relative advantages and disadvantages determine whether it is preferable, indifferent, or dispreferable as an alternative to Y.

This account is then applied to the question of whether animal-free research methods qualify as alternatives to animal research. Doing so breaks down the debate around this question into more focused (ethical and other) issues and illustrates the potential of the account.

First promulgated in 1959, the 3Rs of Replacement, Reduction and Refinement have evolved as fundamental principles underlying the use of animals and alternatives in science throughout the modern world. This review describes a contemporary approach to delivering the 3Rs through acknowledging the contribution of new technologies and emphasising that applying the 3Rs can be beneficial to good science as well as to animal welfare. This science-led approach moves the concept of the 3Rs out of an ethical silo where they were often considered by scientists to be an inconvenient obligation. On the contrary, relevant examples demonstrate the opportunity to practise better science using 3Rs technologies which deliver faster, more reproducible and more cost-effective results. Indeed, methods harnessing Replacement approaches may permit discoveries which are simply not feasible using animals and frequently are more flexible and agile since compliance with regulatory oversight requirements is simplified. Although the necessity for rigorous oversight is well recognised, it is important that the associated bureaucracy is not allowed to become prohibitive, causing scientists to avoid pursuing justifiable and important research involving animals. Public support for research is conditional – animals should not suffer unnecessarily and sufficient potential benefit should accrue from the research. However, society also actively seeks pioneering medical and scientific advances which can only be achieved through research. Therefore, a balance must be struck between safeguarding animal welfare whilst enabling high-quality science. It is this balance which promotes and sustains public confidence that animal based research is acceptable and being appropriately managed.