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New regulation of animal experimentation

New regulation on the use of animals in experimentation was implemented from July 1 2015

New regulation on the use of animals in experimentation was implemented from July 1 2015 The new regulation is called Regulation on the use of animals in research (Norw: "Forskrift om bruk av dyr i forsøk")

After July 1 2015 local decisionauthority by “ansvarshavende” is terminated. 

All applications in FOTS have to be send to Mattilsynet (the Norwegian Food Safety Authority) for decision. 

In addition all application must include (as an attachment) the following information 

  • Information on severity level

  • Public project summary

The application will be processed as quickly as possible, and within 40 or 55 working days, depending on its complexity.

The new regulation causes some more changes indicated below

Background

 

Background for the EU-directive and the New Norwegian regulation of animal experimentation 

 

  • New knowledge on animal welfare
  • Better quality on research in Europe
  • Researcher mobility
  • Competition on same premises with EU

 

Changes for animals

  • Stronger and more explicit focus on the 3R2 (Replacement, Reduction, Refinement) 
  • Ban experiments causing severe pain, fear or any other harm that can be long-lasting and that cannot be relieved. Severe experiments need special justification (based on harm-benefit assessment) 
  • In addition to vertebrate cephalopoder and cyclostomata, decapodes and honey bees will be protected by the regulation 

Changes for researchers

Competence

  • Demonstration of practical skills for all persons doing procedures on animals
  • Continuous professional education and updating of knowledge

 

Application for animal Experiments

  • Lower threshold for application – baseline is everything compared to insert a needle
  • Severity classification, 4 categories (low, moderate, severe or terminal)
  • Ban use of wild-caught, threatened or stray animals without special justification
  • Project summaries will be public available
  • Retrospective evaluation of experiments

Responsibility for animals in experiments.

The primary investigator (project license holder) is responsible for their experiments.

He/she is has to safeguard that

  1. Cause of any unnecessary pain, fear, lasting harm of other negative impact is eliminated as soon as possible

  2. That experiments are performed in exact accordance with the approval and decision made by Mattilsynet

  3. Any deviations and compensatory actions are recorded.

Changes in application process

Application must include:

  • Publication of project summary
  • Severity assessment must be included (low, moderate, severe or terminal)
  • Other euthanasia methods than those described in the regulation needs special justification
  • New demands to application for changes

Project summary

Project summary should be easily understandable to the public.

Project summary shall be anonymous and do not containnames and addresses of the user or persons involved.

The project summary shall include:

  1. Purpose of the study
  2. Expected harm/severity for the animals
  3. Expected benefit for science or society
  4. How many and what kind of animals will be used (totally in this experiment)
  5. How are compliance with the requirements for replacement, reduction and refinement safeguarded

 Project summary shall not contain information that is subject to confidentiality obligation under the law on public administration (Forvatningsloven)

The application will be processed as quickly as possible, and within 40 or 55 working days, depending on its complexity.

Application for changes in FOTS

For application of changes in FOTS the following must be described:

1 The purpose of the change

2. What exactly is changed.

3 A updated project summary including

a) Purpose of the study

b) Expected harm/severity for the animals

c) Expected benefit for science or society

d) How many and what kind of animals will be used (totally in this experiment)

e) How are compliance with the requirements for replacement, reduction and refinement safeguarded

4 If the change cause a different level of severity or benefit of the experiment

5 How many, and which animals are influenced by the change

The application will be processed as quickly as possible, and within 40 or 55 working days, depending on its complexity.

Severity classes