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Commission Implementing Regulation (EU) 2019/1844 of 22 October 2019 granting a Union authorisation for the biocidal product family ‘BPF_Iodine_VET’ (Text with EEA relevance)

EU Regulation 2019/1844 · Adopted 22 October 2019 · Extends to United Kingdom

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Commission Implementing Regulation (EU) 2019/1844

of 22 October 2019

granting a Union authorisation for the biocidal product family ‘BPF_Iodine_VET’

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal productsf1, and in particular the first subparagraph of Article 44(5) thereof,

Whereas:

(1)

On 7 August 2015, Applied Biocide GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘BPF_Iodine_VET’ of product-type 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Austria had agreed to evaluate the application. The application was recorded under case number BC-XJ019074-33 in the Register for Biocidal Products.

(2)

‘BPF_Iodine_VET’ contains iodine, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. Taking into account the intrinsic properties of the active substance, and the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100f2, the Commission will consider the need to review the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will then consider whether the Union authorisations for products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012.

(3)

On 22 August 2018, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

(4)

On 4 April 2019, the Agency submitted to the Commission an opinionf3, including the draft summary of the biocidal product characteristics (‘SPC’) of ‘BPF_Iodine_VET’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concludes that ‘BPF_Iodine_VET’ is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(5)

On 4 June 2019, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(6)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘BPF_Iodine_VET’.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Annotations to the whole text

Footnotes

f1

OJ L 167, 27.6.2012, p. 1.

f2

Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).

f3

ECHA opinion of 27 February 2019 on the Union authorisation of ‘BPF_Iodine_VET’ (ECHA/BPC/219/2019).

Contents

  1. 1Article 1
  2. 2Article 2
  3. Signature
  4. Annex Summary of product characteristics for a biocidal product family
  5. Part I: FIRST INFORMATION LEVEL
  6. ADMINISTRATIVE INFORMATION
  7. 1.1Family name
  8. 1.2Product type(s)
  9. 1.3Authorisation holder
  10. 1.4Manufacturer(s) of the biocidal products
  11. 1.5Manufacturer(s) of the active substance(s)
  12. PRODUCT FAMILY COMPOSITION AND FORMULATION
  13. 2.1Qualitative and quantitative information on the composition of the family
  14. 2.2Type(s) of formulation
  15. Part II: SECOND INFORMATION LEVEL — META SPC(S)
  16. META SPC 1
  17. META SPC 1 ADMINISTRATIVE INFORMATION
  18. 1.1Meta SPC 1 identifier
  19. 1.2Suffix to the authorisation number
  20. 1.3Product type(s)
  21. META SPC 1 COMPOSITION
  22. 2.1Qualitative and quantitative information on the composition of the meta SPC 1
  23. 2.2Type(s) of formulation of the meta SPC 1
  24. 3Hazard and precautionary statements of the meta SPC 1
  25. AUTHORISED USE(S) OF THE META SPC 1
  26. 4.1Use description
  27. 4.1.1Use-specific instructions for use
  28. 4.1.2Use-specific risk mitigation measures
  29. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  30. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  31. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  32. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
  33. 5.1Instructions for use
  34. 5.2Risk mitigation measures
  35. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  36. 5.4Instructions for safe disposal of the product and its packaging
  37. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  38. OTHER INFORMATION
  39. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
  40. 7.1Trade name(s), authorisation number and specific composition of each individual product
  41. META SPC 2
  42. META SPC 2 ADMINISTRATIVE INFORMATION
  43. 1.1Meta SPC 2 identifier
  44. 1.2Suffix to the authorisation number
  45. 1.3Product type(s)
  46. META SPC 2 COMPOSITION
  47. 2.1Qualitative and quantitative information on the composition of the meta SPC 2
  48. 2.2Type(s) of formulation of the meta SPC 2
  49. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
  50. AUTHORISED USE(S) OF THE META SPC 2
  51. 4.1Use description
  52. 4.1.1Use-specific instructions for use
  53. 4.1.2Use-specific risk mitigation measures
  54. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  55. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  56. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  57. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
  58. 5.1Instructions for use
  59. 5.2Risk mitigation measures
  60. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  61. 5.4Instructions for safe disposal of the product and its packaging
  62. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  63. OTHER INFORMATION
  64. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
  65. 7.1Trade name(s), authorisation number and specific composition of each individual product
  66. 7.2Trade name(s), authorisation number and specific composition of each individual product
  67. META SPC 3
  68. META SPC 3 ADMINISTRATIVE INFORMATION
  69. 1.1Meta SPC 3 identifier
  70. 1.2Suffix to the authorisation number
  71. 1.3Product type(s)
  72. META SPC 3 COMPOSITION
  73. 2.1Qualitative and quantitative information on the composition of the meta SPC 3
  74. 2.2Type(s) of formulation of the meta SPC 3
  75. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
  76. AUTHORISED USE(S) OF THE META SPC 3
  77. 4.1Use description
  78. 4.1.1Use-specific instructions for use
  79. 4.1.2Use-specific risk mitigation measures
  80. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  81. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  82. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  83. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
  84. 5.1Instructions for use
  85. 5.2Risk mitigation measures
  86. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  87. 5.4Instructions for safe disposal of the product and its packaging
  88. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  89. OTHER INFORMATION
  90. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
  91. 7.1Trade name(s), authorisation number and specific composition of each individual product
  92. META SPC 4
  93. META SPC 4 ADMINISTRATIVE INFORMATION
  94. 1.1Meta SPC 4 identifier
  95. 1.2Suffix to the authorisation number
  96. 1.3Product type(s)
  97. META SPC 4 COMPOSITION
  98. 2.1Qualitative and quantitative information on the composition of the meta SPC 4
  99. 2.2Type(s) of formulation of the meta SPC 4
  100. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
  101. AUTHORISED USE(S) OF THE META SPC 4
  102. 4.1Use description
  103. 4.1.1Use-specific instructions for use
  104. 4.1.2Use-specific risk mitigation measures
  105. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  106. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  107. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  108. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
  109. 5.1Instructions for use
  110. 5.2Risk mitigation measures
  111. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  112. 5.4Instructions for safe disposal of the product and its packaging
  113. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  114. OTHER INFORMATION
  115. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
  116. 7.1Trade name(s), authorisation number and specific composition of each individual product
  117. 7.2Trade name(s), authorisation number and specific composition of each individual product
  118. META SPC 5
  119. META SPC 5 ADMINISTRATIVE INFORMATION
  120. 1.1Meta SPC 5 identifier
  121. 1.2Suffix to the authorisation number
  122. 1.3Product type(s)
  123. META SPC 5 COMPOSITION
  124. 2.1Qualitative and quantitative information on the composition of the meta SPC 5
  125. 2.2Type(s) of formulation of the meta SPC 5
  126. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
  127. AUTHORISED USE(S) OF THE META SPC 5
  128. 4.1Use description
  129. 4.1.1Use-specific instructions for use
  130. 4.1.2Use-specific risk mitigation measures
  131. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  132. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  133. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  134. GENERAL DIRECTIONS FOR USE OF THE META SPC 5
  135. 5.1Instructions for use
  136. 5.2Risk mitigation measures
  137. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  138. 5.4Instructions for safe disposal of the product and its packaging
  139. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  140. OTHER INFORMATION
  141. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
  142. 7.1Trade name(s), authorisation number and specific composition of each individual product
  143. 7.2Trade name(s), authorisation number and specific composition of each individual product
  144. META SPC 6
  145. META SPC 6 ADMINISTRATIVE INFORMATION
  146. 1.1Meta SPC 6 identifier
  147. 1.2Suffix to the authorisation number
  148. 1.3Product type(s)
  149. META SPC 6 COMPOSITION
  150. 2.1Qualitative and quantitative information on the composition of the meta SPC 6
  151. 2.2Type(s) of formulation of the meta SPC 6
  152. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
  153. AUTHORISED USE(S) OF THE META SPC 6
  154. 4.1Use description
  155. 4.1.1Use-specific instructions for use
  156. 4.1.2Use-specific risk mitigation measures
  157. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  158. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  159. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  160. GENERAL DIRECTIONS FOR USE OF THE META SPC 6
  161. 5.1Instructions for use
  162. 5.2Risk mitigation measures
  163. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  164. 5.4Instructions for safe disposal of the product and its packaging
  165. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  166. OTHER INFORMATION
  167. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
  168. 7.1Trade name(s), authorisation number and specific composition of each individual product
  169. 7.2Trade name(s), authorisation number and specific composition of each individual product
  170. META SPC 7
  171. META SPC 7 ADMINISTRATIVE INFORMATION
  172. 1.1Meta SPC 7 identifier
  173. 1.2Suffix to the authorisation number
  174. 1.3Product type(s)
  175. META SPC 7 COMPOSITION
  176. 2.1Qualitative and quantitative information on the composition of the meta SPC 7
  177. 2.2Type(s) of formulation of the meta SPC 7
  178. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
  179. AUTHORISED USE(S) OF THE META SPC 7
  180. 4.1Use description
  181. 4.1.1Use-specific instructions for use
  182. 4.1.2Use-specific risk mitigation measures
  183. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  184. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  185. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  186. GENERAL DIRECTIONS FOR USE OF THE META SPC 7
  187. 5.1Instructions for use
  188. 5.2Risk mitigation measures
  189. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  190. 5.4Instructions for safe disposal of the product and its packaging
  191. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  192. OTHER INFORMATION
  193. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7
  194. 7.1Trade name(s), authorisation number and specific composition of each individual product
  195. META SPC 8
  196. META SPC 8 ADMINISTRATIVE INFORMATION
  197. 1.1Meta SPC 8 identifier
  198. 1.2Suffix to the authorisation number
  199. 1.3Product type(s)
  200. META SPC 8 COMPOSITION
  201. 2.1Qualitative and quantitative information on the composition of the meta SPC 8
  202. 2.2Type(s) of formulation of the meta SPC 8
  203. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
  204. AUTHORISED USE(S) OF THE META SPC 8
  205. 4.1Use description
  206. 4.1.1Use-specific instructions for use
  207. 4.1.2Use-specific risk mitigation measures
  208. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  209. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  210. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  211. GENERAL DIRECTIONS FOR USE OF THE META SPC 8
  212. 5.1Instructions for use
  213. 5.2Risk mitigation measures
  214. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  215. 5.4Instructions for safe disposal of the product and its packaging
  216. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  217. OTHER INFORMATION
  218. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8
  219. 7.1Trade name(s), authorisation number and specific composition of each individual product