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About the Legislation

Directive 2010/63/EU was transposed into Irish law in December 2012 by SI No 543 of 2012 (as amended*). This legislation aims to improve the welfare of animals used for scientific purposes and to promote the principles of the 3Rs - Replacement, Reduction and Refinement: 

 
Replacement refers to the use of alternative methods which substitute the use of animals for scientific purposes. Where replacement is not possible, animal use must only be permitted where justified and where the expected benefits outweigh the potential adverse effects.
 
Reduction measures must be applied so as to minimise the number of animals used in each research project.
 
Refinement measures must also be applied to enable procedures to be carried out in the most humane manner possible and to minimise pain, suffering, distress and lasting harm.
The following are examples of where the use of animals for scientific purposes may be considered justifiable under the European regulatory framework: 

 
To help discover or develop new treatments or preventative strategies for disease control in human beings, animals or plants;
 
To improve the welfare of animals and to assist in the improvement of production conditions for animals reared for agricultural purposes;
 
For research purposes into the detection, assessment, regulation or modification of physiological conditions in humans, animals or plants;
 
To satisfy European and global regulatory requirements in the manufacture or testing of the quality, safety or engaged of drugs, vaccines, foodstuffs, feedstuffs or products;
 
For the protection of the natural environment in the interests of the health or welfare of humans and animals;
 
To preserve a particular species, or gain insights into their normal behaviours;
 
For higher education;
 
For forensic reasons.
Although we are responsible for the implementation of the legislation, the Department of Health continues to have responsibility for related policy and legislative developments and is the competent authority for the nomination of specialist laboratories to carry out validation studies for alternative approaches as referred to in Articles 47(2) and (5) of the Directive.

*Amendments to SI No 543 of 2012

SI No 434 of 2013
SI No 174 of 2014
SI No 552 of 2016
SI No 553 of 2018