OpenLegislation

Commission Implementing Regulation (EU) 2019/423 of 13 March 2019 granting a Union authorisation for the biocidal product family ‘Teat disinfectants biocidal product family of Novadan’

EU Regulation 2019/423 · Adopted 13 March 2019 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Commission Implementing Regulation (EU) 2019/423

of 13 March 2019

granting a Union authorisation for the biocidal product family ‘Teat disinfectants biocidal product family of Novadan’

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 27 August 2015, SCC GmbH, on behalf of Novadan ApS, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Teat disinfectants biocidal product family of Novadan’ (‘the biocidal product family’) of product-type 3, as described in Annex V to that Regulation. The competent authority of Denmark 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-YV019394-00 in the Register for Biocidal Products.

(2)

The biocidal product family contains iodine, including polyvinylpyrrolidone 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 11 April 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 31 October 2018, 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 17 January 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 6 July 2018 on the Union authorisation of ‘Teat disinfectants biocidal product family of Novadan’ (ECHA/BPC/215/2018).

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. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
  57. 5.1Instructions for use
  58. 5.2Risk mitigation measures
  59. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  60. Description of first aid measures
  61. Environmental emergency measures
  62. 5.4Instructions for safe disposal of the product and its packaging
  63. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  64. 6OTHER INFORMATION
  65. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
  66. 7.1Trade name(s), authorisation number and specific composition of each individual product
  67. META SPC 2
  68. META SPC 2 ADMINISTRATIVE INFORMATION
  69. 1.1Meta SPC 2 identifier
  70. 1.2Suffix to the authorisation number
  71. 1.3Product type(s)
  72. META SPC 2 COMPOSITION
  73. 2.1Qualitative and quantitative information on the composition of the meta SPC 2
  74. 2.2Type(s) of formulation of the meta SPC 2
  75. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
  76. AUTHORISED USE(S) OF THE META SPC 2
  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. 4.2Use description
  84. 4.2.1Use-specific instructions for use
  85. 4.2.2Use-specific risk mitigation measures
  86. 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
  87. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  88. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  89. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
  90. 5.1Instructions for use
  91. 5.2Risk mitigation measures
  92. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  93. Description of first aid measures
  94. Environmental emergency measures
  95. 5.4Instructions for safe disposal of the product and its packaging
  96. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  97. 6OTHER INFORMATION
  98. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
  99. 7.1Trade name(s), authorisation number and specific composition of each individual product
  100. META SPC 3
  101. META SPC 3 ADMINISTRATIVE INFORMATION
  102. 1.1Meta SPC 3 identifier
  103. 1.2Suffix to the authorisation number
  104. 1.3Product type(s)
  105. META SPC 3 COMPOSITION
  106. 2.1Qualitative and quantitative information on the composition of the meta SPC 3
  107. 2.2Type(s) of formulation of the meta SPC 3
  108. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
  109. AUTHORISED USE(S) OF THE META SPC 3
  110. 4.1Use description
  111. 4.1.1Use-specific instructions for use
  112. 4.1.2Use-specific risk mitigation measures
  113. 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
  114. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  115. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  116. 4.2Use description
  117. 4.2.1Use-specific instructions for use
  118. 4.2.2Use-specific risk mitigation measures
  119. 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
  120. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  121. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  122. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
  123. 5.1Instructions for use
  124. 5.2Risk mitigation measures
  125. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  126. Description of first aid measures
  127. Environmental emergency measures
  128. 5.4Instructions for safe disposal of the product and its packaging
  129. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  130. 6OTHER INFORMATION
  131. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
  132. 7.1Trade name(s), authorisation number and specific composition of each individual product
  133. META SPC 4
  134. META SPC 4 ADMINISTRATIVE INFORMATION
  135. 1.1Meta SPC 4 identifier
  136. 1.2Suffix to the authorisation number
  137. 1.3Product type(s)
  138. META SPC 4 COMPOSITION
  139. 2.1Qualitative and quantitative information on the composition of the meta SPC 4
  140. 2.2Type(s) of formulation of the meta SPC 4
  141. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
  142. AUTHORISED USE(S) OF THE META SPC 4
  143. 4.1Use description
  144. 4.1.1Use-specific instructions for use
  145. 4.1.2Use-specific risk mitigation measures
  146. 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
  147. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  148. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  149. 4.2Use description
  150. 4.2.1Use-specific instructions for use
  151. 4.2.2Use-specific risk mitigation measures
  152. 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
  153. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  154. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  155. 4.3Use description
  156. 4.3.1Use-specific instructions for use
  157. 4.3.2Use-specific risk mitigation measures
  158. 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
  159. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  160. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  161. 4.4Use description
  162. 4.4.1Use-specific instructions for use
  163. 4.4.2Use-specific risk mitigation measures
  164. 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
  165. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  166. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  167. 4.5Use description
  168. 4.5.1Use-specific instructions for use
  169. 4.5.2Use-specific risk mitigation measures
  170. 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
  171. 4.5.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  172. 4.5.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  173. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
  174. 5.1Instructions for use
  175. 5.2Risk mitigation measures
  176. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  177. Description of first aid measures
  178. Environmental emergency measures
  179. 5.4Instructions for safe disposal of the product and its packaging
  180. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  181. 6OTHER INFORMATION
  182. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
  183. 7.1Trade name(s), authorisation number and specific composition of each individual product
  184. META SPC 5
  185. META SPC 5 ADMINISTRATIVE INFORMATION
  186. 1.1Meta SPC 5 identifier
  187. 1.2Suffix to the authorisation number
  188. 1.3Product type(s)
  189. META SPC 5 COMPOSITION
  190. 2.1Qualitative and quantitative information on the composition of the meta SPC 5
  191. 2.2Type(s) of formulation of the meta SPC 5
  192. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
  193. AUTHORISED USE(S) OF THE META SPC 5
  194. 4.1Use description
  195. 4.1.1Use-specific instructions for use
  196. 4.1.2Use-specific risk mitigation measures
  197. 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
  198. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  199. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  200. 4.2Use description
  201. 4.2.1Use-specific instructions for use
  202. 4.2.2Use-specific risk mitigation measures
  203. 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
  204. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  205. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  206. 4.3Use description
  207. 4.3.1Use-specific instructions for use
  208. 4.3.2Use-specific risk mitigation measures
  209. 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
  210. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  211. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  212. 4.4Use description
  213. 4.4.1Use-specific instructions for use
  214. 4.4.2Use-specific risk mitigation measures
  215. 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
  216. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  217. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  218. 4.5Use description
  219. 4.5.1Use-specific instructions for use
  220. 4.5.2Use-specific risk mitigation measures
  221. 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
  222. 4.5.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  223. 4.5.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  224. GENERAL DIRECTIONS FOR USE OF THE META SPC 5
  225. 5.1Instructions for use
  226. 5.2Risk mitigation measures
  227. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  228. Description of first aid measures
  229. Environmental emergency measures
  230. 5.4Instructions for safe disposal of the product and its packaging
  231. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  232. 6OTHER INFORMATION
  233. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
  234. 7.1Trade name(s), authorisation number and specific composition of each individual product
  235. META SPC 6
  236. META SPC 6 ADMINISTRATIVE INFORMATION
  237. 1.1Meta SPC 6 identifier
  238. 1.2Suffix to the authorisation number
  239. 1.3Product type(s)
  240. META SPC 6 COMPOSITION
  241. 2.1Qualitative and quantitative information on the composition of the meta SPC 6
  242. 2.2Type(s) of formulation of the meta SPC 6
  243. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
  244. AUTHORISED USE(S) OF THE META SPC 6
  245. 4.1Use description
  246. 4.1.1Use-specific instructions for use
  247. 4.1.2Use-specific risk mitigation measures
  248. 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
  249. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  250. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  251. 4.2Use description
  252. 4.2.1Use-specific instructions for use
  253. 4.2.2Use-specific risk mitigation measures
  254. 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
  255. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  256. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  257. 4.3Use description
  258. 4.3.1Use-specific instructions for use
  259. 4.3.2Use-specific risk mitigation measures
  260. 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
  261. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  262. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  263. 4.4Use description
  264. 4.4.1Use-specific instructions for use
  265. 4.4.2Use-specific risk mitigation measures
  266. 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
  267. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  268. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  269. 4.5Use description
  270. 4.5.1Use-specific instructions for use
  271. 4.5.2Use-specific risk mitigation measures
  272. 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
  273. 4.5.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  274. 4.5.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  275. GENERAL DIRECTIONS FOR USE OF THE META SPC 6
  276. 5.1Instructions for use
  277. 5.2Risk mitigation measures
  278. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  279. Description of first aid measures
  280. Environmental emergency measures
  281. 5.4Instructions for safe disposal of the product and its packaging
  282. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  283. 6OTHER INFORMATION
  284. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
  285. 7.1Trade name(s), authorisation number and specific composition of each individual product