Published: 25 August 2026

European Pharmacopoeia to phase out cruel mouse test

A major victory for animal welfare and modern, animal-free testing methods: The European Directorate for the Quality of Medicines & HealthCare (EDQM) has announced that the gruesome mouse tests for botox will be gradually removed from the European Pharmacopoeia. Doctors Against Animal Experiments (DAAE) explicitly welcomes this long-overdue step and sees it as the result of years of joint campaigns with the European Coalition to End Animal Experiments (ECEAE).

Botulinum toxin, best known under the brand name botox, is used medically for conditions such as eyelid spasms or certain movement disorders, though its predominant use is for aesthetic wrinkle reduction. Yet, for its quality control, mice are still subjected to varying doses of this highly potent neurotoxin. The animals suffer paralysis and respiratory distress, with many dying an agonising death by suffocation. The so-called LD50 test (the lethal dose for 50% of the animals) is classified under EU law as a "severe" animal experiment – the highest severity level. Meanwhile, reliable, cell-based, animal-free test methods have been available for years.

The EDQM and the European Pharmacopoeia Commission have now decided to reactivate their Botulinum Toxin Working Party. This group will develop a roadmap for the gradual phase-out of the LD50 test for botox and revise the relevant texts of the European Pharmacopoeia.

"We are extremely pleased with the EDQM's clear commitment to finally phase out the cruel LD50 tests for botox," says Dr Dilyana Filipova, Scientific Officer at DAAE. "What matters now is that the announced roadmap is developed swiftly and includes binding deadlines that come into force without delay. These tests must be ended completely as quickly as possible."

DAAE and the ECEAE have been campaigning to end botox animal testing for almost two decades. In 2023, the organisations handed over more than 164,000 signatures from across Europe to the European Medicines Agency (EMA). Following this, the EMA placed the issue on its agenda and conducted a survey among all botox producers. Currently, DAAE is again calling for effective action with its campaign "Stop Botox Animal Testing". At European level, the ECEAE is running the "Stop Botox Animal Testing!" campaign.

"Our persistent joint work and the pressure from tens of thousands of supporters have helped ensure that this issue can no longer be ignored today," says Filipova.

Transparency is still lacking on how many mice are used annually for botox testing, for what specific purposes, and by which companies. "Nevertheless, this is a very positive step showing that our engagement is bearing fruit. We will continue to monitor developments closely and remain committed to a complete and immediate ban of these cruel animal tests," adds Filipova.

Reference

First rabbits, now mice: the European Pharmacopoeia turns its attention to phasing out the mouse LD50 assay from its monographs on botulinum toxin. EDQM, press release, 07.08.2026