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Animals used for scientific purposes

Validation, acceptance and use

Regulatory acceptance

Scientific validation should not to be confused with a regulatory acceptance process. Before regulators can accept the use of a particular method in a regulatory context, for example in the area of safety assessment of chemicals, the method has to be:

  • confirmed scientifically valid through a formal (scientific) validation process and
  • assessed as being capable of providing the answers that the respective legislation requires i.e. regulatory acceptance.

The difference between scientific validation and regulatory acceptance process can be demonstrated with a simple example:

  • Method X is scientifically validated to be able to reliably distinguish corrosive from non-corrosive chemicals.
  • Legislation in Country A requires chemicals which are corrosive to be labelled. The outcome of the regulatory acceptance process will confirm that this method can be used for regulatory purposes in this country to distinguish and label corrosive from non-corrosive ones.
  • Legislation in Country B requires chemicals to be labelled as either non-corrosive, mildly corrosive or strongly corrosive. The outcome of the regulatory acceptance process will confirm that the method can only be used to identify non-corrosive chemicals, but another method is still required to distinguish between mildly and strongly corrosive ones.

 

In a nutshell: scientific validation is in most cases a necessary prerequisite for regulatory acceptance but successful validation per se is insufficient to guarantee regulatory acceptance.

 

A number of regulatory bodies both at EU and international level assess methods for regulatory purposes in their respective fields such as for chemicals, pharmaceuticals and food and feed safety. In the EU, Directive 2010/63/EU brings regulators on board early on in the development of new alternative approaches, even before a formal validation starts. Each Member State is required to nominate a single point of contact for regulatory use of animals to speed up regulatory understanding, acceptance and uptake of new methods through the work of a PARERE Network.