Published: 11 August 2025  (Updated: 11 August 2025)

Advancing Chemicals Safety Assessment Through Non-Animal New Approach Methodologies (NAMs)

By Francesca Rapolla, CTPA Senior Affairs Manager, Science

 

Introduction

Fourteen years ago, during my Erasmus placement at Ludwig-Maximilians University in Munich, I undertook a thesis project in pharmaceutical chemistry focussed on the topical delivery of nanoparticles. I was fortunate to work with pig skin in Franz diffusion cell studies, a relatively progressive method at the time. In contrast, many of my peers relied on more conventional - and often ethically challenging - approaches to evaluate the safety and efficacy of drugs and chemicals.

My subsequent career in the cosmetics industry deepened my understanding of safety assessment and introduced me to the evolving landscape of non-animal New Approach Methodologies (NAMs). As animal testing is prohibited for cosmetic ingredients and finished products, the industry has long championed the development and application of animal-free science.

Reflecting on my journey, I could not have anticipated that one of my main responsibilities at the Cosmetic, Toiletry and Perfumery Association (CTPA) would involve promoting education and advocacy for NAMs in both the cosmetics and broader chemicals sectors. This initiative is one I am very passionate about, and I hope to inspire my colleagues.

 

Embracing Change and Scientific Progress

A significant barrier to scientific progress is the challenges associated with moving away from established practices. Tried and tested methods give us the confidence to make decisions about safety, and change often brings uncertainty instead - particularly when new methodologies require re-training or challenge our existing expertise. However, scientific advancement depends on our willingness to explore novel approaches, and for many years there has been a dedicated and expanding community of scientists making important progress in the field of NAMs.

The cosmetics industry has been at the forefront of developing and implementing animal-free testing strategies for over four decades. These methodologies extend beyond direct replacements for traditional tests and encompass comprehensive frameworks such as Next Generation Risk Assessment (NGRA). NGRA enables toxicologists to construct robust safety evaluations using a weight-of-evidence approach, integrating computational models, read-across techniques, in vitro and ex vivo testing, and other NAMs.

Numerous peer-reviewed publications, validated guidelines from international scientific bodies and collaborative efforts among NGOs and regulatory agencies underscore the credibility and applicability of these approaches. Training opportunities - including online courses, university programs, and in-person workshops - are increasingly available to support professionals across academia, industry and regulatory sectors.

 

The Imperative to Learn and Collaborate

Understanding and applying NAMs and NGRA to chemicals safety assessment is essential. While the learning curve may be steep, the journey must begin. Although I am not a toxicologist by training, I have undertaken education in these innovative safety assessment methods and gradually developed confidence in understanding their principles and application.

For toxicologists and other professionals, numerous resources are available to facilitate this transition.  Some examples are listed below, but there are also others available:

  • AFSA Masterclass: A free e-learning platform developed by experts in predictive biology and exposure assessment.
  • British Toxicology Society (BTS) Skills Gap Initiative: Training modules designed to upskill professionals in regulatory toxicology.
  • Vrije Universiteit Brussel (VUB): Courses focusing on cosmetic safety for both human and environmental health.
  • University of Utrecht: A week-long course dedicated to NAMs in toxicology.
  • International Collaboration on Cosmetic Safety (ICCS): Educational resources and scientific publications promoting animal-free assessments.
  • CTPA Training Events: Practical, hands-on workshops to apply NAMs and NGRA in real-world safety assessments. Our upcoming event on 29 September 2025 will focus on the Threshold of Toxicological Concern (TTC), Read-Across principles, and a full NGRA case study.

It is crucial to recognise that mastering these methodologies requires collaboration. Experts in chemistry, toxicology, physiology, computational science and other disciplines must work together, acknowledging that no single individual can possess all the necessary expertise.

 

Overcoming Educational and Regulatory Challenges

Awareness of NAMs and NGRA is expanding along with the growing body of evidence and resources. It is imperative for experts to actively disseminate knowledge, develop educational materials and partner with institutions to facilitate widespread training.

Investment in this area - both financial and human - can be challenging, particularly when regulatory acceptance is uncertain. However, industry leadership is vital to drive regulatory confidence and adoption. Presenting safety dossiers based on NAMs and NGRA is a proactive step toward their regulatory integration.

Education also fosters consistency in applying these methodologies, promoting harmonisation across sectors and enhancing the credibility of animal-free science.

 

Conclusion

I like to think of transitioning to animal-free science in chemical safety assessment like the shift from a basic mobile phone to a smartphone: initially daunting, requiring guidance and adaptation, but ultimately transformative. Begin with a single training session, explore a case study, and take incremental steps toward integrating NAMs and NGRA into your professional practice.

 

CTPA NAMs Practical Training Day

A CTPA NAMs training day will be held on 29 September 2025 in London at Woburn House.  The cost will be £125+VAT for members of CTPA, or £175+VAT for non-members of CTPA.  The deadline for registration is 12 September 2025.

For more information and registration, please click here.

 

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