How Europe and Italy protect animals used in research

Animal research is strictly regulated by European Directive 2010/63/EU and by  Italian Legislative Decree No. 26 dated 4th March 2014.


All research projects involving the use of animals must be approved by the Italian Ministry of Health to which they are submitted by the Animal Welfare Board, which is a statutory body for all legal entities conducting animal experiments.

The Italian Ministry of Health only issues the authorisation to carry out the project after verifying, among other things, that:

  • there are no other alternative methods than the use of animal models
  • the benefit to society from the study is potentially high
  • the proposed study respects the "3 R principle.

These checks are also carried out, together with other extensive controls, by the Animal Welfare Board before the project is submitted to the Italian Ministry of Health.

Experiments requiring the use of animals may only be carried out in premises already authorised by the Italian Ministry of Health, by personnel included in the authorisation decree for the execution of the project who have demonstrated that they have adequate training.

The Italian Ministry of Health and the competent Local Health Authority may carry out checks at any time to verify that research activities are carried out in compliance with the law and the authorisations granted, and that the conditions under which the animals are housed and bred also comply with the regulations in force.

The Italian Ministry of Health carries out further checks even when the trials come to an end. To this end, each Animal Welfare Officer is required to submit information on the number of animals used no later than 31st March each year.  The collection of statistical data in aggregate form is then sent by the Italian Ministry of Health to the European Community, which disseminates it. For further information, please refer to the link (