MIL-OSI Europe: Written question – Continued use of batch potency tests on animals despite accepted non-animal alternatives – E-001392/2025

Question for written answer  E-001392/2025
to the Commission
Rule 144
Tilly Metz (Verts/ALE)

In 2022, 452 699 batch potency tests were conducted in the EU, accounting for 5 % of all animal experiments and 41 % of those carried out for regulatory purposes. Of these, 152 642 tests were performed on mice to comply with human medicines legislation, with a significant proportion likely to be botulinum toxin batch tests, despite the availability of accepted non-animal alternatives.

In view of the above:

• 1.Can the Commission explain why such a large number of batch potency tests continue to be conducted in the EU, and can the Commission provide a list of the products for which these tests are required and explain what is being done to reduce the use of animals in routine batch testing?
• 2.What proportion of these tests were conducted specifically for botulinum toxin products?
• 3.What measures is the Commission taking to ensure that Member States comply with Directive 2010/63/EU by eliminating the use of animals where validated alternatives exist?

Submitted: 4.4.2025