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Commission Implementing Regulation (EU) 2020/202 of 4 October 2019 granting a Union authorisation for the biocidal product family ‘Iodine Teat Dip Products’ (Text with EEA relevance)

EU Regulation 2020/202 · Adopted 4 October 2019 · Extends to United Kingdom

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Commission Implementing Regulation (EU) 2020/202

of 4 October 2019

granting a Union authorisation for the biocidal product family ‘Iodine Teat Dip Products’

(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 Article 44(5) thereof,

Whereas:

(1)

On 20 August 2015, GEA Farm Technologies GmbH, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Iodine Teat Dip Products’ (‘the biocidal 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-AL019223-55 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 6 June 2018, 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 18 January 2019, the Agency submitted to the Commission an opinionf3, including the draft summary of the biocidal product characteristics (‘SPC’) of the biocidal product family 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 the biocidal 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 biocidal product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(5)

On 20 May 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 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 14 December 2018 on the Union authorisation of ‘Iodine Teat Dip Products’ (ECHA/BPC/217/2018).

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. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
  45. 5.1Instructions for use
  46. 5.2Risk mitigation measures
  47. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  48. 5.4Instructions for safe disposal of the product and its packaging
  49. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  50. OTHER INFORMATION
  51. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
  52. 7.1Trade name(s), authorisation number and specific composition of each individual product
  53. 7.2Trade name(s), authorisation number and specific composition of each individual product
  54. 7.3Trade name(s), authorisation number and specific composition of each individual product
  55. 7.4Trade name(s), authorisation number and specific composition of each individual product
  56. META SPC 2
  57. META SPC 2 ADMINISTRATIVE INFORMATION
  58. 1.1Meta SPC 2 identifier
  59. 1.2Suffix to the authorisation number
  60. 1.3Product type(s)
  61. META SPC 2 COMPOSITION
  62. 2.1Qualitative and quantitative information on the composition of the meta SPC 2
  63. 2.2Type(s) of formulation of the meta SPC 2
  64. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
  65. AUTHORISED USE(S) OF THE META SPC 2
  66. 4.1Use description
  67. 4.1.1Use-specific instructions for use
  68. 4.1.2Use-specific risk mitigation measures
  69. 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
  70. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  71. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  72. 4.2Use description
  73. 4.2.1Use-specific instructions for use
  74. 4.2.2Use-specific risk mitigation measures
  75. 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
  76. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  77. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  78. 4.3Use description
  79. 4.3.1Use-specific instructions for use
  80. 4.3.2Use-specific risk mitigation measures
  81. 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
  82. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  83. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  84. 4.4Use description
  85. 4.4.1Use-specific instructions for use
  86. 4.4.2Use-specific risk mitigation measures
  87. 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
  88. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  89. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  90. 4.5Use description
  91. 4.5.1Use-specific instructions for use
  92. 4.5.2Use-specific risk mitigation measures
  93. 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
  94. 4.5.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  95. 4.5.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  96. 4.6Use description
  97. 4.6.1Use-specific instructions for use
  98. 4.6.2Use-specific risk mitigation measures
  99. 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
  100. 4.6.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  101. 4.6.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  102. 4.7Use description
  103. 4.7.1Use-specific instructions for use
  104. 4.7.2Use-specific risk mitigation measures
  105. 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
  106. 4.7.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  107. 4.7.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  108. 4.8Use description
  109. 4.8.1Use-specific instructions for use
  110. 4.8.2Use-specific risk mitigation measures
  111. 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
  112. 4.8.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  113. 4.8.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  114. 4.9Use description
  115. 4.9.1Use-specific instructions for use
  116. 4.9.2Use-specific risk mitigation measures
  117. 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
  118. 4.9.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  119. 4.9.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  120. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
  121. 5.1Instructions for use
  122. 5.2Risk mitigation measures
  123. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  124. 5.4Instructions for safe disposal of the product and its packaging
  125. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  126. OTHER INFORMATION
  127. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
  128. 7.1Trade name(s), authorisation number and specific composition of each individual product
  129. 7.2Trade name(s), authorisation number and specific composition of each individual product
  130. 7.3Trade name(s), authorisation number and specific composition of each individual product
  131. 7.4Trade name(s), authorisation number and specific composition of each individual product
  132. META SPC 3
  133. META SPC 3 ADMINISTRATIVE INFORMATION
  134. 1.1Meta SPC 3 identifier
  135. 1.2Suffix to the authorisation number
  136. 1.3Product type(s)
  137. META SPC 3 COMPOSITION
  138. 2.1Qualitative and quantitative information on the composition of the meta SPC 3
  139. 2.2Type(s) of formulation of the meta SPC 3
  140. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
  141. AUTHORISED USE(S) OF THE META SPC 3
  142. 4.1Use description
  143. 4.1.1Use-specific instructions for use
  144. 4.1.2Use-specific risk mitigation measures
  145. 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
  146. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  147. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  148. 4.2Use description
  149. 4.2.1Use-specific instructions for use
  150. 4.2.2Use-specific risk mitigation measures
  151. 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
  152. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  153. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  154. 4.3Use description
  155. 4.3.1Use-specific instructions for use
  156. 4.3.2Use-specific risk mitigation measures
  157. 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
  158. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  159. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  160. 4.4Use description
  161. 4.4.1Use-specific instructions for use
  162. 4.4.2Use-specific risk mitigation measures
  163. 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
  164. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  165. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  166. 4.5Use description
  167. 4.5.1Use-specific instructions for use
  168. 4.5.2Use-specific risk mitigation measures
  169. 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
  170. 4.5.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  171. 4.5.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  172. 4.6Use description
  173. 4.6.1Use-specific instructions for use
  174. 4.6.2Use-specific risk mitigation measures
  175. 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
  176. 4.6.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  177. 4.6.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  178. 4.7Use description
  179. 4.7.1Use-specific instructions for use
  180. 4.7.2Use-specific risk mitigation measures
  181. 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
  182. 4.7.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  183. 4.7.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  184. 4.8Use description
  185. 4.8.1Use-specific instructions for use
  186. 4.8.2Use-specific risk mitigation measures
  187. 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
  188. 4.8.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  189. 4.8.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  190. 4.9Use description
  191. 4.9.1Use-specific instructions for use
  192. 4.9.2Use-specific risk mitigation measures
  193. 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
  194. 4.9.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  195. 4.9.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  196. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
  197. 5.1Instructions for use
  198. 5.2Risk mitigation measures
  199. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  200. 5.4Instructions for safe disposal of the product and its packaging
  201. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  202. OTHER INFORMATION
  203. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
  204. 7.1Trade name(s), authorisation number and specific composition of each individual product