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Commission Implementing Regulation (EU) 2019/403 of 13 March 2019 granting a Union authorisation for the biocidal product family ‘Deosan Activate BPF based on Iodine’

EU Regulation 2019/403 · Adopted 13 March 2019 · Extends to United Kingdom

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Commission Implementing Regulation (EU) 2019/403

of 13 March 2019

granting a Union authorisation for the biocidal product family ‘Deosan Activate BPF based on Iodine’

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 Article 44(5) thereof,

Whereas:

(1)

On 7 July 2015, Diversey Europe Operations B.V. submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Deosan Activate BPF based on Iodine’ (‘the product family’) of product-type 3, as described in Annex V to that Regulation. The competent authority of United Kingdom agreed to evaluate the application as referred to in Article 43(1) of Regulation (EU) No 528/2012. The application was recorded under the case number BC-JN018376-30 in the Register for Biocidal Products.

(2)

The biocidal product family 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 20 December 2017, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

(4)

On 6 July 2018, the Agency submitted to the Commission an opinionf3, including the draft summary of the biocidal product characteristics (‘SPC’) of the product family and the final assessment report on the product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concludes that the product family falls within the definition of ‘biocidal product family’ laid down in 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, the product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(5)

On 17 September 2018, 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 the biocidal product family.

(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 6 July 2018 on the Union authorisation of ‘Deosan Activate BPF based on Iodine’ (ECHA/BPC/207/2018).

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. 4.2Use description
  33. 4.2.1Use-specific instructions for use
  34. 4.2.2Use-specific risk mitigation measures
  35. 4.2.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  36. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  37. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  38. 4.3Use description
  39. 4.3.1Use-specific instructions for use
  40. 4.3.2Use-specific risk mitigation measures
  41. 4.3.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  42. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  43. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  44. 4.4Use description
  45. 4.4.1Use-specific instructions for use
  46. 4.4.2Use-specific risk mitigation measures
  47. 4.4.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  48. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  49. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  50. 4.5Use description
  51. 4.5.1Use-specific instructions for use
  52. 4.5.2Use-specific risk mitigation measures
  53. 4.5.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  54. 4.5.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  55. 4.5.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  56. 4.6Use description
  57. 4.6.1Use-specific instructions for use
  58. 4.6.2Use-specific risk mitigation measures
  59. 4.6.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  60. 4.6.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  61. 4.6.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  62. 4.7Use description
  63. 4.7.1Use-specific instructions for use
  64. 4.7.2Use-specific risk mitigation measures
  65. 4.7.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  66. 4.7.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  67. 4.7.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  68. 4.8Use description
  69. 4.8.1Use-specific instructions for use
  70. 4.8.2Use-specific risk mitigation measures
  71. 4.8.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  72. 4.8.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  73. 4.8.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  74. 4.9Use description
  75. 4.9.1Use-specific instructions for use
  76. 4.9.2Use-specific risk mitigation measures
  77. 4.9.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  78. 4.9.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  79. 4.9.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  80. 4.10Use description
  81. 4.10.1Use-specific instructions for use
  82. 4.10.2Use-specific risk mitigation measures
  83. 4.10.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  84. 4.10.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  85. 4.10.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  86. 4.11Use description
  87. 4.11.1Use-specific instructions for use
  88. 4.11.2Use-specific risk mitigation measures
  89. 4.11.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  90. 4.11.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  91. 4.11.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  92. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
  93. 5.1Instructions for use
  94. 5.2Risk mitigation measures
  95. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  96. 5.4Instructions for safe disposal of the product and its packaging
  97. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  98. 6OTHER INFORMATION
  99. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
  100. 7.1Trade name(s), authorisation number and specific composition of each individual product
  101. 7.2Trade name(s), authorisation number and specific composition of each individual product
  102. META SPC 2
  103. META SPC 2 ADMINISTRATIVE INFORMATION
  104. 1.1Meta SPC 2 identifier
  105. 1.2Suffix to the authorisation number
  106. 1.3Product type(s)
  107. META SPC 2 COMPOSITION
  108. 2.1Qualitative and quantitative information on the composition of the meta SPC 2
  109. 2.2Type(s) of formulation of the meta SPC 2
  110. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
  111. AUTHORISED USE(S) OF THE META SPC 2
  112. 4.1Use description
  113. 4.1.1Use-specific instructions for use
  114. 4.1.2Use-specific risk mitigation measures
  115. 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
  116. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  117. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  118. 4.2Use description
  119. 4.2.1Use-specific instructions for use
  120. 4.2.2Use-specific risk mitigation measures
  121. 4.2.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  122. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  123. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  124. 4.3Use description
  125. 4.3.1Use-specific instructions for use
  126. 4.3.2Use-specific risk mitigation measures
  127. 4.3.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  128. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  129. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  130. 4.4Use description
  131. 4.4.1Use-specific instructions for use
  132. 4.4.2Use-specific risk mitigation measures
  133. 4.4.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  134. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  135. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  136. 4.5Use description
  137. 4.5.1Use-specific instructions for use
  138. 4.5.2Use-specific risk mitigation measures
  139. 4.5.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  140. 4.5.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  141. 4.5.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  142. 4.6Use description
  143. 4.6.1Use-specific instructions for use
  144. 4.6.2Use-specific risk mitigation measures
  145. 4.6.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  146. 4.6.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  147. 4.6.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  148. 4.7Use description
  149. 4.7.1Use-specific instructions for use
  150. 4.7.2Use-specific risk mitigation measures
  151. 4.7.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  152. 4.7.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  153. 4.7.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  154. 4.8Use description
  155. 4.8.1Use-specific instructions for use
  156. 4.8.2Use-specific risk mitigation measures
  157. 4.8.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  158. 4.8.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  159. 4.8.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  160. 4.9Use description
  161. 4.9.1Use-specific instructions for use
  162. 4.9.2Use-specific risk mitigation measures
  163. 4.9.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  164. 4.9.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  165. 4.9.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  166. 4.10Use description
  167. 4.10.1Use-specific instructions for use
  168. 4.10.2Use-specific risk mitigation measures
  169. 4.10.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  170. 4.10.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  171. 4.10.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  172. 4.11Use description
  173. 4.11.1Use-specific instructions for use
  174. 4.11.2Use-specific risk mitigation measures
  175. 4.11.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  176. 4.11.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  177. 4.11.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  178. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
  179. 5.1Instructions for use
  180. 5.2Risk mitigation measures
  181. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  182. 5.4Instructions for safe disposal of the product and its packaging
  183. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  184. 6OTHER INFORMATION
  185. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
  186. 7.1Trade name(s), authorisation number and specific composition of each individual product
  187. 7.2Trade name(s), authorisation number and specific composition of each individual product
  188. 7.3Trade name(s), authorisation number and specific composition of each individual product
  189. META SPC 3
  190. META SPC 3 ADMINISTRATIVE INFORMATION
  191. 1.1Meta SPC 3 identifier
  192. 1.2Suffix to the authorisation number
  193. 1.3Product type(s)
  194. META SPC 3 COMPOSITION
  195. 2.1Qualitative and quantitative information on the composition of the meta SPC 3
  196. 2.2Type(s) of formulation of the meta SPC 3
  197. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
  198. AUTHORISED USE(S) OF THE META SPC 3
  199. 4.1Use description
  200. 4.1.1Use-specific instructions for use
  201. 4.1.2Use-specific risk mitigation measures
  202. 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
  203. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  204. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  205. 4.2Use description
  206. 4.2.1Use-specific instructions for use
  207. 4.2.2Use-specific risk mitigation measures
  208. 4.2.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  209. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  210. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  211. 4.3Use description
  212. 4.3.1Use-specific instructions for use
  213. 4.3.2Use-specific risk mitigation measures
  214. 4.3.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  215. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  216. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  217. 4.4Use description
  218. 4.4.1Use-specific instructions for use
  219. 4.4.2Use-specific risk mitigation measures
  220. 4.4.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  221. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  222. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  223. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
  224. 5.1Instructions for use
  225. 5.2Risk mitigation measures
  226. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  227. 5.4Instructions for safe disposal of the product and its packaging
  228. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  229. 6OTHER INFORMATION
  230. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
  231. 7.1Trade name(s), authorisation number and specific composition of each individual product