Aspis, the project network for the implementation of new animal-free strategies, gave an update. Aspis is a collaboration between the EU H2020 projects ONTOX, PrecisionTox and RISK-HUNT3R and is funded with a total of 60 million euros. The aim is the sustainable, animal-free and reliable risk assessment of chemicals. A modular framework for next-generation risk assessment called ASPA (ASPIS Safety Profiling Algorithm) was presented. It aims to cover all important regulatory workflows for the hazard, exposure and risk assessment of chemicals. It is a tiered approach to assessing systemic toxicity.

Accelerating recognition
Another session discussed how the development of international test guidelines can be accelerated. How can validation, qualification and standardization be managed in such a way that the process is accelerated? Support and coordination was seen in the EU-NETVAL and PARERE networks. NETVAL is a European EU network for the validation of alternative methods with 33 members across the EU. In addition, new methods submitted for validation to the European validation authority EURL ECVAM for assessment or validation are checked for their probable relevance by the competent authority representatives of the EU member states. This process is called PARERE (Preliminary Assessment of REgulatory RElevance). Interaction with other stakeholder groups and annual meetings are also important.

The regulatory requirements must be taken into account already at an early stage in the development of a method. The requirements are the key. It is not enough to see validation as the solution to all problems. The EFSA states that it has found numerous animal-free methods that are suitable for its studies but have not been validated.

Securing funding
The participants called for validation to be partially covered by EU funding programs such as the EU Framework 10.In the area of medicinal products, the programs are funded by the Innovative Health Initiative (IHI) under Horizon Europe, public-private partnerships and, above all, by the EU member states.

In addition to the EU member states, there is also the European Partnership for Alternative Approaches to Animal Testing (EPAA), although the EPAA's funding is not very pronounced. The discussion of funding as part of the roadmap in recent years was the right approach, but the funding of validation was not sufficiently considered. This must now be made up for. Various structures already exist, it is necessary for them to work together and the question is: have they undergone a readiness assessment?

Bringing order to the objectives
The pharmaceutical giant Merck has developed the 3-basket principle already in 2023. The baskets are colored green, yellow and red, like a traffic light. Animal tests for which alternative methods already exist or which are not scientifically necessary are placed in the green basket. All NAMs have already been developed to such an extent that animal testing can be replaced and these new methods should be mandatory. Animal testing could be quickly eliminated here. The yellow basket contains animal experiments for which concrete ideas or hypotheses such as in silico methods, digital twins etc. already exist to develop alternative methods. The red basket contains animal experiments for which no animal-free approach to replace is yet available. Experts sort their animal activities into the respective baskets. Implementation plans with milestones are required for all methods in the green basket, prioritization of research and development funding for the methods in the yellow basket, and primarily investment in refinement measures for those in the red basket. The industry's roadmap consists of classifying its animal testing activities in order to draw up recommendations for the sector that will be incorporated into the EU roadmap, modernize science and secure business activities.

In the field of cosmetics, international cooperation is seen as a challenge, but the participants are convinced that a completely animal-free program will be possible in the sector in the future. Overall, it is not only the success of rescued animals that counts, but also the progress for industry and small and medium-sized enterprises.

Stakeholder input for the roadmap
From the animal rights side, it was said that the short-term actions were important.All NAMs have already been developed to such an extent that animal testing can be replaced and these methods should be mandatory. Animal testing could be quickly eliminated here. More education, training and further training in NAMs and more political action are needed.
The representative of the European Medicines Agency (EMA) encouraged people to work on the NAMs that are already available and to share data and build trust.There are opportunities in the guidelines, but they are not being used. Incentives should be provided for data sharing and a safe space created for this.