Transparency and Status of The 3Rs Under Directive 2010/63/EU

Openness and transparency are key values of the European society and research. Research may unfortunately still involve – at certain stages – the testing of animals for academic or regulatory purposes (fundamental biological research, pharmaceuticals, immunologicals, infectiology, surgery, medical devices, chemicals, environment, food and feed).

Since 2010 protection of animals which are to be used for scientific purposes is commonly agreed upon and requested legally in Europe as per Directive 2010/63/EU on the protection of animals used for scientific purposes (latest consolidation in 2019). Animal testing on cosmetics and the marketing of such products has even been prohibited in the EU.

The animal protection directive was amended by Regulation 2019/1010 with requirements for the reporting of statistical data on the use of animals for scientific purposes in the EU for which two implementing decisions have been adopted: Commission Implementing Decision 2012/707/EU and Commission Implementing Decision 2020/569/EU. So therefore, transparent data on animals used for scientific purposes in the EU is readily available.

Starting in 2014 the counting methods of the test animals have changed: Since then, all animals had to be counted at the beginning of each experiment and reported at the completion of the trial. With that some animals were counted one, two or even three times, like explained by the German Primate Centre (DPZ). With that it makes sense to start comparing numbers after 2014. Let us have a look and see how experimental animal numbers have developed over the last years (Graph 1: Number of all animals used in the EU (and Norway in 2018/2019) from 2015–2019). As you can clearly see the numbers of all animals used for testing, routine production, education, training purposes, research in the EU has increased and even so the numbers from Norway were included in the last two years, that might not be the only reason why numbers are not dropping as desired and anticipated. On the other hand on ALURES – European Commission ( the latest numbers of the past 3 years are not published (yet).

The German BfR (Bundesamt für Risikobewertung) at least published the numbers from 2020 and compared them to 2019. They state that the numbers are clearly decreasing. In the year 2019 round about 3 million animals were used for scientific purposes and in the year 2020 only approx. 2,5 million.1 But in the published figures of the BfR, only the animals used for scientific purposes were listed. So the animals used for education, routine production, etc. are not included. Therefore again, it is questionable if the numbers are actually decreasing.