Full master class in animal-free safety assessment now launched

Fifty years ago, it would have been hard to imagine that the safety of chemicals including cosmetics and consumer products could be assessed without relying on animal tests. Fortunately, our scientific knowledge and practises have progressed significantly since then, with 45 countries having banned cosmetic animal testing and compelling industry to rely entirely on non-animal approaches to determine cosmetic safety. While this scientific shift was gathering momentum, legislative testing prohibitions propelled the use of modern, safe, non-animal testing methods.

Evidence is accumulating that non-animal approaches to chemical safety are outperforming the old animal-reliant system. So why does the safety assessment for consumer products, industrial chemicals, pesticides, etc., around the world still rely so heavily on animal testing? Progress is being made, but significant challenges to the transition toward animal-free safety testing remain.

Legislative evolution

Complications arise when ingredients are used both in cosmetics and in other contexts that fall under industrial chemical legislation that require animal testing. While several regions have introduced language intended to minimize animal testing in chemicals legislation (e.g. the EU under reach or the United States under the Toxic Substances Control Act), such legislation also includes requirements for specific animal data — which is also the case for pesticides legislation around the world. To facilitate the use of non-animal methods, more effort is needed to improve the regulatory acceptance of flexible, integrated approaches to testing and assessment in which different types of information are combined to address the legislated data requirements.

Following resounding calls from the general public and European Parliament, the European Commission (EC) has committed to developing a roadmap to the eventual phase-out of animal testing in the chemical industry. Similar roadmaps have been developed in the US and are in development in Canada; their goal being to pave the way to a future where few, if any, animals are used in chemical safety assessment.

Confidence in new approaches relies on familiarity

European Parliament has stressed the “need for a sustained training and education effort to ensure the widest possible knowledge of alternatives and processes” to accelerate animal-free scientific innovation. In October 2024 the second European Commission workshop on the roadmap for phasing out animal testing took place. Jay Ingram, the director of chemicals at Humane Society International, says , “A key indicator of the success of the roadmap will be a paradigm shift in the field of regulatory safety assessment; reducing knowledge barriers whilst building confidence in Non-Animal Methods and Next Generation Risk Assessment is essential to ensuring all interested parties have the necessary tools and vocabulary to effect this paradigm change.”

To support such educational efforts, the Animal-Free Safety Assessment Collaboration (AFSA) gathered a global team of toxicology experts to develop a free, online training course that focuses on the safety assessment of cosmetic products and ingredients without new animal data. The AFSA Master Class covers all aspects of the safety assessment process, from the initial problem formulation through to the final assessment conclusion. This includes modules on consumer exposure, predictive chemistry, exposure-based waiving, dosimetry and internal exposure estimation, in vitro methods, and a module that brings these approaches together in detailed case examples of complete assessments for 11 different problem formulations, including genotoxicity, phototoxicity, skin and eye irritation, dermal sensitization, and various longer-term systemic effects. The master class is designed to enhance the capacity to perform animal-free safety assessments of cosmetics and ingredients globally.

The course emphasizes that the non-animal approach to assessing safety is conceptually not that different from the historical approach based on animal testing. The major differences are that the animal-free approach relies on estimations of exposure from the beginning and throughout the assessment process. Moreover, an estimation of the bioactivity of the chemical relies on combining predictive and non-animal data that are integrated in specific ways to address different regulatory concerns rather than a defined list of tests performed for each chemical.

Since the course launched, over 1,250 users from 76 different countries have enrolled, demonstrating the growing global appetite for training on cruelty-free testing methods. Registrants represent a number of professions and disciplines, including regulators, product manufacturers, contract research organisations, and academics, evidencing the universal nature of the shift required and the readiness to upskill across the board.

Ensuring the highest degree of human and environmental safety remains a priority as the shift toward animal-free methods progresses. These methods are typically required to undergo a rigorous validation process before being accepted for use in regulatory assessments. Moreover, the overall animal-free approach is designed not to predict specific outcomes in animals (other than for acute endpoints like skin and eye irritation, skin sensitization), but rather to understand how chemicals can be used safely (‘protection not prediction’). The entire approach tends to overestimate both human exposure and the bioactivity of an ingredient, ensuring that the modern, animal-free methods are both protective and human-relevant.

“The safety of the cosmetics and personal care products that consumers use and trust every day is of the utmost importance,” says Dr Julia H Fentem, the global head of safety, environmental and regulatory science at Unilever. “Our unique AFSA Master Class program is focused on the safety assessment of cosmetic products and ingredients without generating new animal data and covers all aspects of using non-animal tools and data for internal company decision-making as well as regulatory safety assessments.”

As society collectively strives toward a safer and kinder future for people and the planet, the cosmetic and chemical sectors must keep pace. We want to ensure that toxicologists and regulatory assessors are equipped with the right tools and knowledge to fulfil the European’s Commissions commitment — to end cosmetic and chemical animal testing without compromising human safety. We look forward to the continued growth of the AFSA Master Class, and hope that this multi-party effort to disseminate knowledge will contribute to the wider shift toward a cruelty-free future for cosmetic and chemical safety testing.

Access all modules of the AFSA Master Class for free here.