EU Roadmap on Animal Testing

The European Commission has published its long-awaited roadmap toward phasing out animal testing for chemical safety assessments. The message is clear: Europe wants to accelerate the transition from traditional animal tests to innovative non-animal approaches. But the roadmap also makes one thing very clear: this transition will only happen where scientifically reliable and regulatorily accepted alternatives are available.

This is not an immediate ban on animal experiments. The roadmap focuses on chemical safety assessments and covers 15 legislative areas, including industrial chemicals, consumer products, pesticides, biocides, food and feed additives, medical device biocompatibility and chemical pharmaceuticals. Biologicals, vaccines, gene therapies and advanced therapy medicinal products are excluded from this specific scope.

The European Commission describes the transition as both an ethical objective and an opportunity for innovation and competitiveness. Between 2015 and 2023, more than 15 million animals were used for regulatory testing in the EU, with almost 40% linked to chemical safety assessments. At the same time, the Commission stresses that non-animal methods must provide a level of protection equivalent to established methods.

Industry groups have welcomed the roadmap. EFPIA, representing the research-based pharmaceutical industry, called it an important step toward ethical, science-based innovation and highlighted the need to qualify human-relevant non-animal methods. Cefic also welcomed the roadmap as a structured, realistic pathway, while emphasizing that the next challenge is implementation, validation and regulatory acceptance. (EFPIA)

Animal welfare organisations also welcomed the announcement, but with a different emphasis: they see it as a milestone that must now move from ambition to delivery. Eurogroup for Animals and partner organisations pointed out that around 500,000 animal procedures are still carried out annually in the EU for chemical safety assessment requirements. (Eurogroup for Animals)

Why this matters for cell culture and in vitro research

The key question is no longer whether alternatives to animal testing are needed. They are. The real question is whether these alternatives are robust, reproducible, predictive and accepted by regulators.

History shows that this takes time. Reconstructed human epidermis models for skin corrosion testing are a good example. The EpiSkin Skin Corrosion Test was evaluated by EURL ECVAM in the mid-1990s and later became part of internationally validated approaches for skin corrosion testing. OECD Test Guideline 431, based on reconstructed human epidermis models, was originally adopted in 2004 and later updated. (Joint Research Centre)

This shows the reality behind the roadmap: alternatives do not become regulatory replacements overnight. They require development, validation, standardisation, reproducibility data and acceptance by authorities.

Non-animal does not always mean animal-free

There is another important point that is often overlooked. Many in vitro models are described as “non-animal” because they do not use live animals in the test itself. However, the production or culture of these models may still depend on animal-derived components.

Examples can include fetal bovine serum, bovine pituitary extract, animal-derived collagen, trypsin or other biological supplements. A systematic review of in vitro skin sensitisation methods found that many methods still used animal-derived products, with fetal bovine serum reported in most of the analysed methods. Recent work on full-thickness human skin models also notes that traditional systems often use animal-derived collagen, FBS and BPE, which can affect reproducibility and raise ethical and technical concerns. (Sage Journals)

This means the future of animal testing replacement is not only about replacing animal experiments. It is also about improving the quality of the alternatives themselves.

The next step: better-defined human cell-based systems

For laboratories working with human cell culture, the EU roadmap is a strong signal. Human-relevant in vitro systems will become increasingly important but only if they are well characterised, reproducible and suitable for the intended application.

This creates growing demand for:

• human primary cells and stem cell-derived models

• defined and chemically defined media

• xeno-free and animal-origin-free culture conditions

• reliable 2D and 3D cell culture systems

• organotypic and tissue-like models

• validated assay workflows

• better standardisation across laboratories

At PELOBiotech, we can support researchers and industry partners in this transition. Our portfolio includes human cell culture solutions, primary cells, stem cell products, defined media, ACF media, xeno-free and animal-component-free options, 3D culture tools, assay systems and related reagents for more reliable in vitro workflows.

Depending on the application, not every system can be converted to animal-component-free conditions immediately. But many workflows can already be improved by choosing better-defined media, reducing animal-derived supplements and working with more human-relevant cell culture systems.

The future will not simply be “non-animal”.

The future must be human-relevant, reproducible and better defined.

PELOBiotech helps researchers take the next step toward more reliable, standardised and animal-reduced in vitro models.