# Commission Implementing Decision (EU) 2020/569 of 16 April 2020 establishing a common format and information content for the submission of the information to be reported by Member States pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes and repealing Commission Implementing Decision 2012/707/EU (notified under document C(2020) 2179) (Text with EEA relevance), Part A: Template for the submission of non-technical project summaries referred to in article 43(1) of directive 2010/63/EU

Extent: E+W+S+N.I.

Including scientific terms which may consist of more than 5 individual words and excluding species and purposes entered elsewhere in the document
To be provided via a dropdown menu
List of purposes in accordance with statistical reporting categories and sub-categories in Annex III to this Decision
Species in accordance with statistical reporting categories in Annex III to this Decision, with an additional option of ‘non-specified mammal’ to safeguard anonymity in exceptional cases
Species to be populated from the previous response to select from under the relevant category (proportions)
Multiple choices per species possible
Multiple choices possible; applicable to those MS where this information is required by the legislation
Title of the project
Duration of project
(in months)
Key Words (maximum of 5)
Purpose of project
(multiple choices possible)
Basic research
Translational and applied research
Regulatory use and routine production:
Quality control (including batch safety and potency testing)
Other efficacy and tolerance testing
Toxicity and other safety testing including pharmacology
Routine production
Protection of the natural environment in the interests of the health or welfare of human beings or animals
Preservation of species
Higher education
Training
Forensic enquiries
Maintenance of colonies of genetically altered animals, not used in other procedures
Objectives and predicted benefits of the project
Describe the objectives of the project (for example, addressing certain scientific unknowns, or scientific or clinical needs).
What are the potential benefits likely to derive from this project? Explain how science could be advanced, or humans, animals or environment may ultimately benefit from the project. Where applicable, differentiate between short-term benefits (within the duration of the project) and long-term benefits (which may accrue after the project is finished).
Predicted harms
In what procedures will the animals typically be used (for example, injections, surgical procedures)? Indicate the number and duration of these procedures.
What are the expected impacts/adverse effects on the animals, for example pain, weight loss, inactivity/reduced mobility, stress, abnormal behaviour, and the duration of those effects?
What species and numbers of animals are expected to be used? What are the expected severities and the numbers of animals in each severity category (per species)?
Species
Estimated total numbers
Estimated numbers per severity
Non-recovery
Mild
Moderate
Severe
What will happen to the animals kept alive at the end of the procedure? ,
Estimated number to be reused
Estimated number to be returned to habitat/husbandry system
Estimated number to be rehomed
Please provide reasons for the planned fate of the animals after the procedure.
Application of the Three Rs
1. Replacement
State which non-animal alternatives are available in this field and why they cannot be used for the purposes of the project.
2. Reduction
Explain how the numbers of animals for this project were determined. Describe steps that have been taken to reduce the number of animals to be used, and principles used to design studies. Where applicable, describe practices that will be used throughout the project to minimise the number of animals used consistent with scientific objectives. Those practices may include e.g. pilot studies, computer modelling, sharing of tissue and reuse.
3. Refinement
Give examples of the specific measures (e.g., increased monitoring, post-operative care, pain management, training of animals) to be taken, in relation to the procedures, to minimise welfare costs (harms) to the animals. Describe the mechanisms to take up emerging refinement techniques during the lifetime of the project.
Explain the choice of species and the related life stages.
Project selected for Retrospective Assessment
Deadline
Contains severe procedures
Uses non-human primates
Other reason

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Source: https://www.legislation.gov.uk/eudn/2020/569/annex/I/part/A (the official version)
Page: https://openlegislation.uk/eu-decision-2020-569/annex-I/part-A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.