INFORMATION REFERRED TO IN ARTICLE 54(1) OF DIRECTIVE 2010/63/EU
ANNEX IISupplementary provisions
ANNEX II INFORMATION REFERRED TO IN ARTICLE 54(1) OF DIRECTIVE 2010/63/EU A. NATIONAL MEASURES ON THE IMPLEMENTATION OF DIRECTIVE 2010/63/EU Provide information on changes made to national measures regarding the implementation of Directive 2010/63/EU since the previous report. B. STRUCTURES AND FRAMEWORK 1. Competent authorities (Article 59 of Directive 2010/63/EU) Explain the framework for competent authorities, including the numbers and types of authorities as well as their respective tasks, and explain the measures taken to ensure compliance with the requirements of Article 59(1) of Directive 2010/63/EU. 2. National committee (Article 49 of Directive 2010/63/EU) Explain the structure and operation of the national committee, and the measures taken to ensure compliance with the requirements of Article 49 of Directive 2010/63/EU. 3. Education and training of personnel (Article 23 of Directive 2010/63/EU) Provide information on the minimum requirements referred to in Article 23(3) of Directive 2010/63/EU; describe any additional educational and training requirements for staff coming from another Member State. 4. Project evaluation and authorisation (Articles 38 and 40 of Directive 2010/63/EU) Explain the processes of project evaluation and authorisation, and the measures taken to ensure compliance with the requirements of Articles 38 and 40 of Directive 2010/63/EU. C. OPERATION 1. Projects 1.1. Granting of project authorisation (Articles 40 and 41 of Directive 2010/63/EU) 1.1.1. In respect of each year, provide numbers for the following: (a) all authorisation decisions and authorised projects; (b) multiple generic projects, as provided for in Article 40(4) of Directive 2010/63/EU, categorised as one of the following types: — projects to satisfy regulatory requirements; — projects using animals for production purposes; — projects using animals for diagnostic purposes; (c) the authorisation decisions where the deadline of 40 days has been extended in accordance with Article 41(2) of Directive 2010/63/EU. 1.1.2. For the purposes of point (c), provide summary information, covering the five-year reporting cycle, on the reasons where the deadline of 40 days has been extended. 1.2. Retrospective assessment, non-technical project summaries (Article 38(2)(f), Articles 39 and 43 of Directive 2010/63/EU) 1.2.1. Explain the measures taken to ensure compliance with the requirements of Article 43(1) of Directive 2010/63/EU and indicate whether there is a requirement for non-technical project summaries to specify that a project is to undergo retrospective assessment (Article 43(2) of Directive 2010/63/EU). 1.2.2. In respect of each year, provide the number of projects authorised that are to undergo a retrospective assessment in accordance with Article 39(2) of Directive 2010/63/EU and the number of projects authorised that are to undergo a retrospective assessment under Article 38(2)(f) of that Directive. Categorise each of those projects as one of the following types: (a) projects using non-human primates; (b) projects involving procedures classified as ‘severe’; (c) projects using non-human primates and involving procedures classified as ‘severe’; (d) other projects that are to undergo a retrospective assessment. 1.2.3. Provide summary information, covering the five-year reporting cycle, on the nature of projects selected for retrospective assessment in accordance with Article 38(2)(f) of Directive 2010/63/EU that are not automatically subject to retrospective assessment in accordance with Article 39(2). 2. Animals bred for use in procedures (Articles 10, 28 and 30 of Directive 2010/63/EU) 2.1. Provide the species and numbers of animals that were bred and born (including by Caesarean section) for use in procedures and, having never been used in any procedures, were killed during the calendar year immediately preceding that in which the five-year report is submitted. 2.1.1. Include animals killed for organs or tissues and animals from the creation and maintenance of genetically altered (GA) animal lines, which are not covered in the annual statistics pursuant to Article 54(2) of Directive 2010/63/EU. 2.1.2. Categorise these animals as one of the following types: (a) genetically normal animals not providing organs and/or tissues; (b) genetically normal animals providing organs and/or tissues; (c) GA animals providing organs and/or tissues; (d) genetically normal animals (wild type offspring) as a result of the creation of a new GA line; (e) animals from the maintenance of a GA line covering all GA and wild type offspring of both harmful and non-harmful phenotype. 2.1.3. The category referred to in point (a) excludes animals as a result of a creation of a new GA line and from the maintenance of a GA line, which are to be reported in the categories referred to in points (d) and (e) respectively; 2.1.4. The categories referred to in points (b) and (c) include animals as a result of creation of a new GA line and from maintenance of a GA line, when providing organs and/or tissues; 2.1.5. The categories referred to in points 2.1.2(d) and (e) exclude the following animals, which are to be reported in the annual statistics pursuant to Article 54(2) of Directive 2010/63/EU: (a) animals that were genotyped using invasive methods; (b) animals from a harmful phenotype line that experienced adverse effect. 2.2. Explain the measures taken to ensure compliance with the requirements of Articles 10 and 28 of Directive 2010/63/EU when sourcing non-human primates. 3. Exemptions 3.1. Provide summary information, covering the five-year reporting cycle, on circumstances under which exemptions were granted in accordance with Article 10(3), the second subparagraph of Article 12(1) and Article 33(3) of Directive 2010/63/EU. 3.2. Provide information for the same period on any exceptional circumstances as referred to in Article 16(2) of that Directive where the reuse of an animal was authorised after a procedure in which the suffering of that animal was assessed to have been severe. 4. Animal welfare body (Articles 26 and 27 of Directive 2010/63/EU) Explain the measures taken to ensure compliance with the requirements regarding the structure and functioning of animal welfare bodies of 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 and Annex VI of Directive 2010/63/EU) 1.1. Provide information on the measures taken to ensure that the principles of (a) replacement, (b) reduction and (c) refinement are satisfactorily addressed within authorised projects in accordance with Articles 4 and 13 of Directive 2010/63/EU. 1.2. Provide information on the measures taken to ensure that the principles of (a) reduction and (b) refinement are satisfactorily addressed during housing and care in breeding and supplying establishments in accordance with Article 4 of Directive 2010/63/EU. 2. Avoidance of duplication (Article 46 of Directive 2010/63/EU) Explain how duplication of procedures is avoided to comply with Article 46 of Directive 2010/63/EU. 3. Tissue sampling of genetically altered animals (Articles 4, 30 and 38 of Directive 2010/63/EU) 3.1. In respect of tissue sampling for the purposes of genetic characterisation carried out with and without project authorisation, provide representative information and numbers regarding species, methods and their related actual severity. That information shall be provided only for the calendar year immediately preceding that in which the five-year report is submitted. 3.2. List the criteria used to ensure that the information in point 3.1 is representative. 3.3. Provide information on efforts made to refine tissue sampling methods. E. ENFORCEMENT 1. Authorisation of breeders, suppliers and users (Articles 20 and 21 of Directive 2010/63/EU) 1.1. In respect of each year, provide numbers for all active authorised breeders, suppliers and users separately. 1.2. Provide summary information, covering the five-year reporting cycle, on reasons for suspensions or withdrawals of authorisations of breeders, suppliers and users. 2. Inspections (Article 34 of Directive 2010/63/EU) 2.1. In respect of each year, provide numbers for inspections, broken down by announced and unannounced. 2.2. Provide summary information, covering the five-year reporting cycle, on main findings of inspections. 2.3. Explain the measures taken to ensure compliance with the requirements of Article 34(2) of Directive 2010/63/EU. 3. Withdrawals of project authorisation (Article 44 of Directive 2010/63/EU) Provide summary information, covering the five-year reporting cycle, on reasons for the withdrawal of project authorisations. 4. Penalties (Article 60 of Directive 2010/63/EU) 4.1. Provide summary information, covering the five-year reporting cycle, on the nature of the following: (a) infringements; (b) administrative actions in response to infringements; (c) legal actions in response to infringements.