As global awareness of animal welfare in preclinical research increases, expectations and regulations for research institutions are evolving rapidly. Compliance with stringent legislation and adherence to ethical standards are essential not only for scientific credibility but also for maintaining public trust in research. With new regulatory frameworks emerging and events like the 16th FELASA Congress promoting responsible scientific conduct with animals in the life sciences, now is the ideal time for researchers to review and strengthen their compliance strategies.

In our recent blog post, we highlighted how Somark is pioneering innovative animal identification systems, an essential component of ensuring animal welfare in preclinical research and maintaining compliance with the 3Rs principles. Our commitment to welfare will be showcased when we participate in FELASA’s discussions on reducing severity in animal studies, a theme that reflects the broader movement toward more humane and scientifically rigorous research practices, all guided by the principles of Reduce, Refine, Replace.

Mouse Identification and Compliance: Regulatory Standards for Animal Welfare in Preclinical Research

Understanding the regulatory landscape

Around the world, multiple organisations set strict frameworks for the ethical treatment of animals in research. The World Organization for Animal Health (WOAH, formerly OIE) collaborates with the World Health Organization (WHO) under the “One Health” framework, which recognises the interconnectedness of humans, animals, and the environment. A recent study published by Research Ethics highlights how One Health principles provide a useful framework for animal behaviour and welfare research, optimising the health and wellbeing of humans, animals, and ecosystems.

Within One Health there is an “explicit mention of both animal welfare and ecosystem integrity both reinforces that researchers should take care of participants in their studies whether the subjects are humans, other sentient animals, or ecosystems, and highlights the relevance of animal behavior and welfare sciences to behavioral ecology, epidemiology and other ecological and health sciences, and to identifying and describing sustainable solutions and human behavior change to secure the wellbeing of current and future generations.”

WOAH sets the international standards for animal health and welfare, which influence national laws like the Animal Welfare Act  (AWA), EU Directive 2010/63/EU, and the UK’s Animal Scientific Procedures Act 1986 (ASPA). By enforcing these strict standards, the WOAH is able to ensure that globally, animal welfare practices remain consistent, especially when it comes to areas like disease control and humane treatment.

The Animal Welfare Act (AWA), enforced by the USDA since 1966, establishes minimum standards for research, teaching, testing, exhibition, transport, and dealer activities. Institutions receiving federal funding must also comply with the Public Health Service (PHS) Policy, which requires oversight by Institutional Animal Care and Use Committees (IACUCs).

In Europe, EU Directive 2010/63/EU is among the most comprehensive animal welfare legislations worldwide. Recognising animals as sentient beings, it imposes strict ethical requirements on all procedures involving live non-human vertebrates and cephalopods. Its 2019 amendment (Regulation (EU) 2019/1010) introduced enhanced reporting and transparency requirements, supporting the ultimate goal of reducing and eventually replacing animal use.

In the UK, the Animal and Scientific Procedures Act 1986 (ASPA) protects animals used for scientific purposes. Across all jurisdictions, international frameworks like WOAH guide national laws to uphold consistent welfare standards.

At the heart of these regulations and ethical frameworks lie the 3Rs principles – Replacement, Reduction, and Refinement, which underpin responsible research and reinforce a commitment to humane, scientifically sound practices in preclinical research.

Future Legislation and Evolving Standards in Animal Welfare for Preclinical Research

As an industry thought leader, Somark recognises the critical importance of keeping pace with evolving regulations. Governments and regulatory bodies are increasingly prioritising enhanced animal welfare in preclinical research, including better identification and monitoring methods, higher welfare standards, and comprehensive documentation of humane practices. FELASA’s focus on reducing severity aligns closely with these initiatives, underscoring the need for proactive adaptation.

What does all this mean for researchers? It means that the time to act is now.

Globally, regulatory authorities are strengthening their oversight of humane research practices. Institutions that fail to adapt risk falling behind or facing compliance penalties. For example, the Animals in Science Regulation Unit (ASRU) reported an 860% increase in breaches in the UK between 2022 and 2023. ASRU’s 2021 audit system, which relied heavily on self-reporting, is currently under review with further changes expected in 2025.

Across the industry, significant changes are already underway. Invasive identification techniques are being phased out, with many universities permitting them only when accompanied by additional procedures, such as genotyping. As more humane alternatives become available, research institutions are expected to justify the use of any method causing physical alteration or pain. This indicates that ethical standards are rising, particularly regarding procedures that may not be scientifically necessary.

One other major shift is the increasing emphasis on formal Three Rs reporting. In the UK, Animals (Scientific Procedures) Act requires that researchers have to provide detailed documentation  on how they apply the 3Rs within their studies, including considering the harm and benefits, along with the welfare considerations for the animals. While many researchers already integrate the principles into their workflows, upcoming changes in some regions may soon require that these considerations be documented, reviewed, and audited as part of regular compliance protocols.

Legislative recognition of animal sentience is also expanding, influencing how species are treated in research and what procedures are considered acceptable. In parallel, training and education are becoming mandatory. Researchers and laboratory personnel must stay current on the latest animal welfare standards, ethical practices, and legislative updates. Routine training is no longer optional, it is now a compliance requirement.

Mitigating Future Risks in Animal Welfare and Preclinical Research

Institutions that adopt best practices today are better prepared for tomorrow’s regulatory expectations.

As leaders in laboratory animal identification, Somark delivers unmatched accuracy and consistency, supporting animal welfare in preclinical research and strengthening your 3Rs credentials.

Whether it’s Labstamp, the world’s only automated mouse identification system, or Digitail System featuring the smallest RFID animal ID tag, Somark offers innovative, proven solutions. With over a decade of experience, we reduce errors in both the application and reading of animal IDs, setting the standard in humane research practices.

By reducing severity, embracing innovation, and embedding ethical considerations throughout the research process, we help build a future where scientific progress goes hand-in-hand with responsibility and respect for animal welfare.

We’re proud to contribute to this conversation at this year’s FELASA Congress. Visit us at Booth B83 or sign up for our mailing list to stay updated on our latest innovations and insights.