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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)

EU Decision 2020/569 · Adopted 16 April 2020 · Extends to United Kingdom

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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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposesf1, and in particular Article 43(4) and Article 54(4) thereof,

Whereas:

(1)

Following the amendments provided for in Regulation (EU) 2019/1010 of the European Parliament and of the Councilf2, Directive 2010/63/EU now requires Member States to submit non-technical project summaries of authorised projects, and any updates thereto, by electronic transfer to the Commission. In order to enable the Commission to establish and maintain a central database for those summaries and updates and to ensure that meaningful searches can be carried out on that data, a uniform presentation of those summaries and updates is needed. Therefore, templates should be established for submitting the non-technical project summaries, and any updates thereto, and Member States should be required to upload such summaries and updates to the database established by the Commission.

(2)

Directive 2010/63/EU also requires Member States to submit information on the implementation of that Directive, as well as statistical information on the use of animals in procedures, by electronic transfer to the Commission.

(3)

On the basis of the information submitted by the Member States on the implementation of Directive 2010/63/EU, the Commission services are to publish and regularly update a Union overview. Directive 2010/63/EU also requires the Commission services to make the statistical data submitted by the Member States and a summary report thereof publicly available on an annual basis. To enable the Commission to satisfy both of those requirements, the content of that information should be established by laying down information categories.

(4)

As regards information on implementation, the information categories to be reported on should correlate with the relevant requirements of Directive 2010/63/EU. As regards statistical information, it is necessary to specify the statistical data input categories available in the searchable, open access database established by the Commission pursuant to Directive 2010/63/EU.

(5)

In order to improve transparency and to reduce the administrative burden, Member States should be required to use the database established by the Commission for the purposes of submitting the information on the implementation of Directive 2010/63/EU as well as the statistical information on the use of animals in procedures.

(6)

The content and format of the detailed information to be submitted by Member States on the methods considered to be at least as humane as those contained in Annex IV to Directive 2010/63/EU should be specified in a way that allows the list of methods for the killing of animals contained in that Annex to be kept up to date. Therefore, it is appropriate to lay down a template allowing for the submission of information on the type of method, the species concerned and the justification for granting an exemption, and to require Member States to use that template.

(7)

The empowerments on which this Decision is based are closely linked as they both deal with the reporting of information by Member States under Directive 2010/63/EU. Given this substantive link, and to ensure a consistent and coherent approach, it is appropriate to adopt a single Decision establishing all requirements falling within the scope of those empowerments. It is therefore necessary to replace Commission Implementing Decision 2012/707/EUf3, in which the common format for the submission of the information referred to in Article 54 of Directive 2010/63/EU is laid down, by a new Implementing Decision based on both Article 43(4) and Article 54(4) of Directive 2010/63/EU. Implementing Decision 2012/707/EU should therefore be repealed.

(8)

The measures provided for in this Decision are in accordance with the opinion of the Animals in Science Committee,

HAS ADOPTED THIS DECISION:

Annotations to the whole text

Footnotes

f1

OJ L 276, 20.10.2010, p. 33.

f2

Regulation (EU) 2019/1010 of the European Parliament and of the Council of 5 June 2019 on the alignment of reporting obligations in the field of legislation related to the environment, and amending Regulations (EC) No 166/2006 and (EU) No 995/2010 of the European Parliament and of the Council, Directives 2002/49/EC, 2004/35/EC, 2007/2/EC, 2009/147/EC and 2010/63/EU of the European Parliament and of the Council, Council Regulations (EC) No 338/97 and (EC) No 2173/2005, and Council Directive 86/278/EEC (OJ L 170, 25.6.2019, p. 115).

f3

Commission Implementing Decision 2012/707/EU 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 (OJ L 320, 17.11.2012, p. 33).

Contents

  1. 1Article 1
  2. 2Article 2
  3. 3Article 3
  4. 4Article 4
  5. 5Article 5
  6. 6Article 6
  7. Signature
  8. Annex I
  9. ATemplate for the submission of non-technical project summaries referred to in article 43(1) of directive 2010/63/EU
  10. BTemplate for the submission of an update to the non-technical project summary referred to in article 43(2) of directive 2010/63/EU
  11. Annex II: INFORMATION REFERRED TO IN ARTICLE 54(1) OF DIRECTIVE 2010/63/EU
  12. ANATIONAL MEASURES ON THE IMPLEMENTATION OF DIRECTIVE 2010/63/EU
  13. STRUCTURES AND FRAMEWORK
  14. 1Competent authorities (Article 59 of Directive 2010/63/EU)
  15. 2National committee (Article 49 of Directive 2010/63/EU)
  16. 3Education and training of personnel (Article 23 of Directive 2010/63/EU)
  17. 4Project evaluation and authorisation (Articles 38 and 40 of Directive 2010/63/EU)
  18. OPERATION
  19. Projects
  20. Granting of project authorisation (Articles 40 and 41 of Directive 2010/63/EU)
  21. 1.1.1In respect of each year, provide numbers for the following:
  22. 1.1.2Division 1.1.2
  23. Retrospective assessment, non-technical project summaries (Article 38(2)(f), Articles 39 and 43 of Directive 2010/63/EU)
  24. 1.2.1Division 1.2.1
  25. 1.2.2In 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:
  26. 1.2.3Division 1.2.3
  27. Animals bred for use in procedures (Articles 10, 28 and 30 of Directive 2010/63/EU)
  28. 2.1Division 2.1
  29. 2.1.1Division 2.1.1
  30. 2.1.2Categorise these animals as one of the following types:
  31. 2.1.3Division 2.1.3
  32. 2.1.4Division 2.1.4
  33. 2.1.5The 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:
  34. 2.2Division 2.2
  35. Exemptions
  36. 3.1Division 3.1
  37. 3.2Division 3.2
  38. 4Animal welfare body (Articles 26 and 27 of Directive 2010/63/EU)
  39. PRINCIPLES OF REPLACEMENT, REDUCTION AND REFINEMENT
  40. Principle of replacement, reduction and refinement (Articles 4 and 13 and Annex VI of Directive 2010/63/EU)
  41. 1.1Division 1.1
  42. 1.2Division 1.2
  43. 2Avoidance of duplication (Article 46 of Directive 2010/63/EU)
  44. Tissue sampling of genetically altered animals (Articles 4, 30 and 38 of Directive 2010/63/EU)
  45. 3.1Division 3.1
  46. 3.2Division 3.2
  47. 3.3Division 3.3
  48. ENFORCEMENT
  49. Authorisation of breeders, suppliers and users (Articles 20 and 21 of Directive 2010/63/EU)
  50. 1.1Division 1.1
  51. 1.2Division 1.2
  52. Inspections (Article 34 of Directive 2010/63/EU)
  53. 2.1Division 2.1
  54. 2.2Division 2.2
  55. 2.3Division 2.3
  56. 3Withdrawals of project authorisation (Article 44 of Directive 2010/63/EU)
  57. Penalties (Article 60 of Directive 2010/63/EU)
  58. 4.1Provide summary information, covering the five-year reporting cycle, on the nature of the following:
  59. Annex III
  60. AFlowchart of statistical data input categories under article 54(2) of directive 2010/63/EU
  61. Part B: Information referred to in article 54(2) of directive 2010/63/EU
  62. GENERAL PROVISIONS
  63. 1Division 1
  64. 2Division 2
  65. 3Animals killed for organs and tissues
  66. 4Animals that are bred and killed without being used in a procedure
  67. 5Division 5
  68. 6Division 6
  69. 7Division 7
  70. 8Division 8
  71. 9Division 9
  72. 10Division 10
  73. 11Genetically altered animals
  74. BDATA INPUT CATEGORIES
  75. 1Type of animal
  76. 1.1Division 1.1
  77. 1.2Division 1.2
  78. 1.3Division 1.3
  79. 1.4Division 1.4
  80. 2Reuse
  81. 2.1General
  82. 2.2Reuse versus continued use
  83. 3Species other than non-human primate – Place of birth
  84. 3.1Division 3.1
  85. 3.2Division 3.2
  86. 3.3Division 3.3
  87. 3.4Division 3.4
  88. 3.5Division 3.5
  89. 4Non-human primate (NHP) – Place of birth
  90. 4.1Division 4.1
  91. 4.2Division 4.2
  92. 4.3Division 4.3
  93. 4.4Division 4.4
  94. 4.5Division 4.5
  95. 4.6Division 4.6
  96. 4.7Division 4.7
  97. 5Non-human primate – Colony type
  98. 6Non-human primate – Generation
  99. 6.1Division 6.1
  100. 6.2Division 6.2
  101. 6.3Division 6.3
  102. 7Genetic status
  103. 7.1Division 7.1
  104. 7.2‘Genetically altered without a harmful phenotype’ refers to
  105. 7.3‘Genetically altered with a harmful phenotype’ refers to
  106. 8Creation of a new genetically altered line
  107. 9Severity
  108. 9.1Division 9.1
  109. 9.2Severity categories
  110. 9.3Animals found dead
  111. 9.4Capture and transport of animals taken from the wild
  112. 10Purposes
  113. 10.1Basic research
  114. 10.2Translational and applied research
  115. 10.3Regulatory use and Routine production
  116. 10.4Protection of the natural environment in the interests of the health or welfare of human beings or animals
  117. 10.5Higher education
  118. 10.6Training for the acquisition, maintenance or improvement of vocational skills
  119. 10.7Maintenance of colonies of established genetically altered animals, not used in other procedures
  120. 11Basic research studies
  121. 11.1Oncology
  122. 11.2Nervous system
  123. 11.3Musculoskeletal System
  124. 11.4Sensory Organs (skin, eyes and ears)
  125. 11.5Division 11.5
  126. 11.6Multisystemic
  127. 11.7Division 11.7
  128. 11.8Other Basic Research
  129. 11.9Remarks
  130. 12Translational and applied research
  131. 12.1Division 12.1
  132. 12.2Division 12.2
  133. 12.3Division 12.3
  134. 12.4Division 12.4
  135. 12.5Division 12.5
  136. 12.6Division 12.6
  137. 12.7Division 12.7
  138. 12.8Division 12.8
  139. 12.9Remarks
  140. 13Regulatory use and Routine production
  141. 13.1Division 13.1
  142. 13.2Division 13.2
  143. 13.3Other efficacy and tolerance testing
  144. 13.4Toxicity and other safety testing (including safety evaluation of products and devices for human medicine and dentistry and veterinary medicine)
  145. 13.5Routine production by product type
  146. 14Quality control (including batch safety and potency testing)
  147. 15Toxicity and other safety testing by test type
  148. 15.1Division 15.1
  149. 15.2Division 15.2
  150. 15.3Division 15.3
  151. 15.4Division 15.4
  152. 15.5Division 15.5
  153. 15.6Division 15.6
  154. 15.7Division 15.7
  155. 15.8Division 15.8
  156. 16Acute toxicity testing methods
  157. 16.1Division 16.1
  158. 16.2Division 16.2
  159. 16.3Division 16.3
  160. 17Repeated dose toxicity
  161. 18Ecotoxicity
  162. 18.1Division 18.1
  163. 18.2Division 18.2
  164. 18.3Division 18.3
  165. 18.4Division 18.4
  166. 19Type of legislation
  167. 19.1Division 19.1
  168. 19.2Division 19.2
  169. 19.3Division 19.3
  170. 20Origin of legislation
  171. 20.1Division 20.1
  172. 20.2Division 20.2
  173. 20.3Division 20.3
  174. 20.4Division 20.4
  175. 20.5Division 20.5
  176. 20.6Division 20.6
  177. 21Routine production by product type
  178. 21.1Division 21.1
  179. 21.2Division 21.2
  180. 21.3Division 21.3
  181. MEMBER STATE NARRATIVE
  182. 1Member States shall provide a narrative on the statistical data. That narrative shall contain the following:
  183. 2For the purposes of point 1(g), the following shall be reported:
  184. Annex IVTEMPLATE FOR THE SUBMISSION OF THE INFORMATION REFERRED TO IN ARTICLE 54(3) OF DIRECTIVE 2010/63/EU
  185. Annex VCORRELATION TABLE