164,770 signatures against Botox animal testing
FILE PHOTO: The exterior of the European Medicines Agency is seen in Amsterdam, Netherlands, December 18, 2020. REUTERS/Piroschka van de Wouw/File Photo - RC21PZ9CFR2O

164,770 signatures against Botox animal testing

Meeting with the European Medicines Agency EMA in Amsterdam

21 April 2023

Tens of thousands of mice are still suffocated to test botulinum toxin products — better known by the trade name “Botox” — even though non-animal methods have been around for 12 years. The European Coalition to End Animal Experiments (ECEAE) is calling for a deletion of the mouse test in the European Pharmacopoeia. Today, the umbrella organization handed over 164,770 signatures collected across Europe to the European Medicines Agency EMA. The competent authority EDQM had previously refused to accept the petition.

The neurotoxin botulinum toxin is best known for its use in cosmetics, for example to smooth facial lines. However, it is also used for medical purposes, for example against torticollis. Regardless of the application, every single batch is tested before it is allowed to go on sale. This is usually done using the so-called LD50 test on mice. Groups of mice are injected with the substance in various dilutions into the abdominal cavity to determine the dose at which half of the animals die (LD50 = lethal dose 50 percent). The toxin causes respiratory paralysis, which can lead to an agonizing death by suffocation.

The European Pharmacopoeia requires the LD50 test, although also the use of non-animal methods is allowed. Since 2011, the three most important manufacturers Allergan, Merz and Ipsen have received official approval for their animal-free tests and thus have reduced the animal testing numbers at least to a large degree.

Nevertheless, tens of thousands of mice are still suffering for botox products in Europe. In 2021, botox tests on 22,440 mice were approved in Germany. In Ireland, over 82,000 mice were killed for botox testing alone, that’s nearly 70% of all animal experiments conducted in this country in 2021.

The European Coalition to End Animal Experiments (ECEAE) has been running a Europe-wide campaign against the cruel tests since 2009 and has had some success when the biggest manufacturers switched at least mostly to animal-free testing.

The umbrella organisation is calling for the LD50 test to be deleted from the European Pharmacopoeia. The authority responsible for this, the European Directorate for the Quality of Drugs EDQM, had previously refused to accept the petition.

Today, April 20th, a three-person delegation from the ECEAE met with representatives from the EMA in Amsterdam and handed over the petition with 164,770 signatures.

The EMA is collaborating with the EDQM on a number of issues and the ECEAE called the EMA to exert its influence to get the botox test on mice removed from the regulatory framework.