5 August 2024

Directive 2010/63/EU establishes common EU measures for the protection of animals used for scientific purposes, but the way the Directive is implemented differs between EU Member States. A new implementation report highlights this heterogeneity, particularly in areas where the Directive lacks specific, detailed provisions.

Member States are required to send information on the implementation of Directive 2010/63/EU to the European Commission every five years. Following the first report in 2019, the second report, covering the period 2018-2022, has just been published.

Education and training

The Directive requires appropriate education and training for staff carrying out procedures, caring for animals, killing animals and designing procedures and projects. However, implementation rests largely with Member States, which can decide independently how competence should be demonstrated.

Most Member States mentioned that they follow the EU Education and Training Framework document, but did not explicitly explain how competence should be demonstrated beyond having obtained the required education. 

Project evaluation and authorisation

During project evaluation, applications must be carefully considered to ensure that animal use is justified, the principles of the 3Rs (replacement, reduction and refinement) are applied, and that the benefits are expected to outweigh the anticipated harms. 2 Member States use individuals to evaluate projects, whereas the others use a panel.

Around 15 000 projects involving the use of animals are authorised across the EU and Norway annually. The number of projects has remained reasonably constant throughout the five-year reporting period, and only around 4.5% of applications are rejected each year.

Competence of project evaluators is assured in different ways. However, it seems that there may be scope for improved training to ensure a consistent approach across the Member States. Many Member States discussed the required qualifications of project evaluators, but only Ireland mentioned expertise in the area of non-animal methods.

It is surprising that there was no explanation on how to achieve harmonisation when project evaluation is carried out by multiple competent authorities from some Member States.

Only one Member State confirmed that applicants are never involved in the project evaluation of their own work.

Animals bred and killed but not used in procedures

This category includes animals killed for their organs and/or tissues, animals used for breeding when they reach the end of their breeding life, animals which were ill and humanely killed before being used, and animals killed in order to protect the health and scientific integrity of the colony. They are not reported in the annual statistics.

In 2022, 9.5 million animals were bred and killed but not used in procedures. This means that there are more animals that fall into this category than the number of animals that are actually used in procedures. Mice, zebrafish and rats account for more than 90% of the animals reported.

Inspections

20 Member States complied with the requirement to inspect at least 1/3 of the user establishments each year. Greece, Croatia and Portugal appear not to have met this criterion for any of the years reported.

According to the Directive, an appropriate proportion of inspections must be carried out without a prior warning. Across the Union, around 1/3 of inspections were unannounced. However, the proportion of unannounced inspections varied between Member States from 0-100%. This suggests that different criteria are being applied to determine “an appropriate proportion.”

8 Member States performed no unannounced inspections which is the same number as in the first report. Cyprus and Portugal performed no unannounced inspections over the ten years covered by the two implementation reports.

18 Member States acknowledged that they did not meet the minimum requirements for inspection in any of the reporting years.

Penalties

Nearly 3/4 Member States reported infringements, and 21 Member States have used administrative actions. Infringements which were dealt with by administrative action were due to failings in animal welfare, staff, records, environment, and facilities.

Almost half of the Member States used legal actions, of which two-thirds were fines.

Structure of competent authorities

The Directive requires that the authorisation of establishments, inspections, project evaluation, project authorisation and retrospective assessment are performed by a competent authority. 7 Member States have only one competent authority for each of the five tasks (Denmark, Ireland, Cyprus, Malta, Portugal, Slovenia, Norway), while other Member States have very large numbers of competent authorities (for example, 112 in Spain; 245 in Italy, 328 in Poland and 573 in Germany).

It may be challenging to provide a consistent approach where there are multiple competent authorities responsible for the same individual tasks. Large numbers of competent authorities for any or all tasks increase the risk of inconsistencies.

Summary

The implementation reports are an opportunity to show how Member States have been working since the implementation of the Directive, understand where they encounter difficulties, but also highlight best practices so that they can learn from each other. 

The lack of harmonisation across Member States continues to have a negative impact on the objective of creating a level playing field across the EU, but also, and importantly, on animal welfare. 

Regards Mark