As awareness surrounding animal welfare grows globally, the expectations and regulations focusing on preclinical research institutions are also evolving simultaneously. Compliance with stringent regulations and adherence to ethical standards are not only essential for scientific credibility but also key for maintaining public trust in research. With stricter legislation emerging, and events like the 16th FELASA Congress advocating for responsible scientific conduct with animals in the life sciences, now is the time for researchers to re-evaluate their compliance strategies.

In our recent blog post, we explored how at Somark, we are leading the way in innovative animal identification systems – an essential part of maintaining compliance with the 3R’s and minimizing harm. Our commitment to animal welfare will be evident when we join FELASA’s conversation on reducing severity in animal research – a theme that underscores the broader movement toward more humane and scientifically rigorous research, all underpinned by the 3Rs principles – reduce, refine, replace.

Mouse Identification: Current standards and best practices

Compliance: Understanding the regulatory landscape

Around the world there are a number of organizations who set the strict framework for the ethical treatment of animals in research.

The World Organization for Animal Health (formally OIE) works closely with World Health Organization (WHO) under the framework of “One Health” which recognizes the connection between humans, animals and the environment. A recent study published by Research Ethics explores the link between the One Health approach and animal behavior and welfare research. Highlighting that the principles within the One Health approach offer a useful “framework for animal behavior and welfare research to optimize the health and wellbeing of humans, animals and the environment.”

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), is enforced by the USDA, and has been in place since 1966. It mandates basic standards for research, teaching, testing, exhibition, transport, as well as for dealers. In addition to this, institutions who receive federal funding must also adhere to the Public Health Service (PHS) Policy, which requires oversight by Institutional Animal Care and Use Committees (IACUCs).

In Europe, the EU Directive 2010/63/EU represents one of the most comprehensive welfare legislations globally. It recognizes animals as sentient beings and applies strict ethical requirements to all procedures involving live non-human vertebrates, as well as live cephalopods. In 2019 Directive 2010/63 was amended by Regulation (EU) 2019/1010 to incorporate the big goals for reporting and transparency, which all play a part in helping towards the final goal of total replacement of animal use.

In the UK, the purpose of ASPA (Animal and Scientific Procedures Act 1986) is to protect animals used for scientific or experimental purposes. Beyond individual countries, it is the World Organization for Animal Health (WOAH) that sets international standards that influence national laws.

At the core of all these regulations and ethical frameworks lies the foundational principle of the 3Rs – Replacement, Reduction, and Refinement – which guide responsible animal research and underscore the commitment to humane and scientifically sound practices.

What’s changing in future legislation?

As a thought leader within the industry, Somark recognizes the importance of evolving regulations. Governments and regulatory bodies are pushing for better identification and monitoring methods, enhanced welfare standards, and comprehensive documentation of humane practices. FELASA’s focus on reducing severity aligns with these goals, emphasizing the need for proactive adaptation.

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

Across the globe, governments and regulatory bodies are strengthening their focus on humane research practices. Institutions and regulation organizations that fail to adapt risk falling behind or facing compliance penalties. The Animals in Science Regulation Unit (ASRU) released a report that the rise in breaches within the UK rose 860% from 2022 to 2023. In 2021 the ASRU introduced a new audit system which heavily relied on self-reporting; however, this is currently undergoing a review with further changes expected in 2025.

Across the industry, we are already seeing many changes taking place. One key example is the phasing out of invasive identification techniques, with many universities stating it is only acceptable along with additional procedures such as genotyping. As more humane alternatives become available, research institutions are expected to justify the use of any method that causes physical alteration or pain. This is a clear indication that the bar is rising for what’s considered ethical, especially when it comes to procedures that may not be considered 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.

There is also a growing recognition of animal sentience in legislative language. This expanded ethical scope will likely influence how different species are treated in research and what procedures are considered acceptable. Lastly, training and education are becoming non-negotiable. Researchers and lab personnel must be continually educated on the latest animal welfare standards, ethical care practices, and legislative updates. Routine training is no longer a best practice—it’s becoming a compliance requirement.

Mitigating future risk

Institutions that proactively adopt best practices today will be far better positioned to meet tomorrow’s expectations.

As leaders in laboratory animal identification solutions our technology deliver new levels of study data accuracy and consistency, promoting animal welfare refinements for your 3Rs credentials.

Regardless of the identification method you choose, whether it be Labstamp, the world’s only automated system for identifying mice, or our advanced Digitail System, a digital solution featuring the world’s smallest RFID animal identification tag – Somark offers proven, innovative animal ID technology. With over a decade of experience pioneering animal identification, we offer unmatched expertise and innovation to every next-generational product available at Somark Innovations . Whether it is the first, the only, or the smallest of its kind, you can trust that Somark sets the standard, with a history of transforming animal and mouse identification methods by reducing and eliminating errors in both the application and reading of animal IDs.

By reducing severity, embracing innovation, and embedding ethical considerations into every stage of the research process, we can build a future where scientific progress goes alongside responsibility and respect for animal welfare.

At Somark Innovations, we’re proud to be part of that future – and we look forward to contributing to the conversation at this year’s FELASA Congress. Let’s move forward together and shape a research world where better welfare leads to better science.

Will we see you at FELASA? Head to Booth B83 to start a discussion with our team; alternatively you can sign up for our mailing list here to be the first to hear of our exciting developments ahead of the event!