# 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), Division 10.2: Translational and applied research

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

10.2.1. ‘Translational and applied research’ refer to animals used for purposes as described in Article 5(b) and (c) excluding any regulatory use of animals (see point 10.3. below).
10.2.2. This also includes discovery toxicology and investigations to prepare for the regulatory submission and method development. This does not include studies required for regulatory submissions.
10.2.3. The animals used for the creation of a new genetically altered animal line intended to be used for the purposes of translational or applied research (for example, cancer research, vaccine development) shall be recorded according to the purpose they are being created for. In addition, they shall be reported in ‘Creation of a new genetic line – Animals used for the creation of a new genetically altered line/strain’.
10.2.4. All animals carrying the genetic alteration shall be reported during the creation of a new line. Also animals used in creation, such as for superovulation, vasectomy and embryo implantation shall be reported here. The reporting shall exclude non-genetically altered (wild type) offspring.
10.2.5. A new strain or line of genetically altered animals is considered to be ‘established’ where transmission of the genetic alteration is stable, which will be a minimum of two generations, and a welfare assessment has been completed.

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Source: https://www.legislation.gov.uk/eudn/2020/569/annex/III/part/B/division/B/division/10/division/10.2 (the official version)
Page: https://openlegislation.uk/eu-decision-2020-569/annex-III/part-B/division-B/division-10/division-10.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.