Article 1. . . . . . . . . ....
Article 2. . . . . . . . . ....
Article 3. . . . . . . . . ....
Article 4. . . . . . . . . ....
ANNEX I REPORTING FORMAT FOR THE SUBMISSION OF THE INFORMATION REFERRED TO IN ARTICLE 54(1) OF DIRECTIVE 2010/63/EU
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A.GENERAL INFORMATION
B.STRUCTURES AND FRAMEWORK
1.Competent authorities (Article 59 of Directive 2010/63/EU)
2.National committee (Article 49 of Directive 2010/63/EU)
3.Education and training of personnel (Article 23 of Directive 2010/63/EU)...
4.Project evaluation and authorisation (Articles 38 and 40 of Directive...
C.OPERATION
1.Projects
2.Animals bred for use in procedures (Articles 10, 28 and...
3.Exemptions
4.Animal welfare body (Articles 26 and 27 of Directive 2010/63/EU)...
D.PRINCIPLES OF REPLACEMENT, REDUCTION AND REFINEMENT
1.Principle of replacement, reduction and refinement (Articles 4 and 13...
2.Avoidance of duplication (Article 46 of Directive 2010/63/EU)
3.Tissue sampling of genetically altered animals (Articles 4, 30 and...
E.ENFORCEMENT
1.Authorisation of breeders, suppliers and users (Articles 20 and 21...
2.Inspections (Article 34 of Directive 2010/63/EU)
3.Withdrawals of project authorisation (Article 44 of Directive 2010/63/EU)
4.Penalties (Article 60 of Directive 2010/63/EU)
ANNEX II
PART A FLOWCHART OF STATISTICAL DATA INPUT CATEGORIES UNDER ARTICLE 54(2) PART B DETAILED INSTRUCTIONS FOR THE PROVISION OF STATISTICAL DATA ON THE USE OF ANIMALS FOR SCIENTIFIC PURPOSES UNDER ARTICLE 54(2)
REPORTING FORMAT FOR THE SUBMISSION OF THE INFORMATION REFERRED TO...
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9.. . . . . . . . . ....
A.GENETICALLY ALTERED ANIMALS
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2.Genetically altered animals are reported either:
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9.. . . . . . . . . ....
B.DATA CATEGORIES
1.Type of animal
(i). . . . . . . . . ....
(ii). . . . . . . . . ....
(iii). . . . . . . . . ....
2.Reuse
(i). . . . . . . . . ....
(ii). . . . . . . . . ....
(iii). . . . . . . . . ....
(iv). . . . . . . . . ....
(v). . . . . . . . . ....
Reuse versus continued use
3.Place of birth
(i). . . . . . . . . ....
(ii). . . . . . . . . ....
(iii). . . . . . . . . ....
(iv). . . . . . . . . ....
4.Non-human primate — source
5.Non-human primate — generation
(i). . . . . . . . . ....
(ii). . . . . . . . . ....
6.Genetic status
(i). . . . . . . . . ....
(ii). . . . . . . . . ....
(iii)Genetically altered with a harmful phenotype includes:
7.Creation of a new genetically altered line
8.Severity
(i). . . . . . . . . ....
(ii). . . . . . . . . ....
(iii). . . . . . . . . ....
(iv). . . . . . . . . ....
(v). . . . . . . . . ....
9.Purposes
(i)Basic research
(ii)Translational and applied research
(iii)Regulatory use and routine production by type
(iv)Protection of the natural environment in the interests of the...
(v)Higher education or training for the acquisition, maintenance or improvement...
(vi)Maintenance of colonies of established genetically altered animals, not used...
10.Basic research studies
(i)Oncology
(ii)Nervous system
(iii)Sensory Organs (skin eyes and ears)
(iv)Multisystemic
(v). . . . . . . . . ....
(vi)Other
(vii)Remarks
11.Translational and applied research
(i). . . . . . . . . ....
(ii). . . . . . . . . ....
(iii). . . . . . . . . ....
(iv). . . . . . . . . ....
(v). . . . . . . . . ....
(vi). . . . . . . . . ....
(vii)Remarks
12.Regulatory use and routine production
(i). . . . . . . . . ....
(ii). . . . . . . . . ....
(iii). . . . . . . . . ....
13.Regulatory use and routine production by type
(i). . . . . . . . . ....
(ii). . . . . . . . . ....
(iii). . . . . . . . . ....
(iv). . . . . . . . . ....
(v). . . . . . . . . ....
14.Testing by legislation
(i). . . . . . . . . ....
(ii). . . . . . . . . ....
15.Legislative requirements
(i). . . . . . . . . ....
(ii). . . . . . . . . ....
(iii). . . . . . . . . ....
(iv). . . . . . . . . ....
(v). . . . . . . . . ....
16.Quality control (incl. batch safety and potency testing)
17.Toxicity and other safety testing by test type
(i). . . . . . . . . ....
(ii). . . . . . . . . ....
(iii). . . . . . . . . ....
(iv). . . . . . . . . ....
18.Acute and subacute toxicity testing methods
19.Repeated dose toxicity
20.Use of animals for regulated production by product type
21.Ecotoxicity
C.MEMBER STATE NARRATIVE
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ANNEX III
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Commission Implementing Decision

of 14 November 2012

establishing a common format for the submission of the information pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes

(notified under document C(2012) 8064)

(Text with EEA relevance)

(2012/707/EU) (repealed)

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .