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Commission Implementing Regulation (EU) 2020/1187 of 7 August 2020 granting a Union authorisation for the biocidal product family ‘Iodine based products – CID LINES NV’ (Text with EEA relevance)

EU Regulation 2020/1187 · Adopted 7 August 2020 · 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) 2020/1187

of 7 August 2020

granting a Union authorisation for the biocidal product family ‘Iodine based products – CID LINES NV’

(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 13 August 2015, CID LINES NV submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Iodine based products – CID LINES NV’ of product-types 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-BY019142-30 in the Register for Biocidal Products.

(2)

‘Iodine based products – CID LINES NV’ 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 is carrying out a review of 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 consider whether the Union authorisations for products containing the active substance have to be cancelled or amended in accordance with Article 48 of Regulation (EU) No 528/2012.

(3)

On 28 May 2019, 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 17 January 2020, the Agency submitted to the Commission an opinionf3, including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Iodine based products – CID LINES NV’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5)

The opinion concludes that ‘Iodine based products – CID LINES NV’ 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.

(6)

On 4 February 2020 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.

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Iodine based products – CID LINES NV’.

(8)

According to the opinion of the Agency, as regards the non-active substances sodium iodide and sodium iodate contained in ‘Iodine based products – CID LINES NV’, it was not possible to conclude whether they meet the scientific criteria for the determination of endocrine-disrupting properties set out in Delegated Regulation (EU) 2017/2100 within the period for the evaluation of the application. Further examination of sodium iodide and sodium iodate should therefore take place. If it is concluded that sodium iodide or sodium iodate or both are considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘Iodine based products – CID LINES NV’ in accordance with Article 48 of Regulation (EU) No 528/2012.

(9)

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 11 December 2019 on the Union authorisation of ‘Iodine based products – CID LINES NV’ (ECHA/BPC/237/2019).

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. Instructions for use
  85. For disinfection of the skin:
  86. 5.2Risk mitigation measures
  87. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  88. 5.4Instructions for safe disposal of the product and its packaging
  89. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  90. OTHER INFORMATION
  91. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
  92. 7.1Trade name(s), authorisation number and specific composition of each individual product
  93. 7.2Trade name(s), authorisation number and specific composition of each individual product
  94. META SPC 4
  95. META SPC 4 ADMINISTRATIVE INFORMATION
  96. 1.1Meta SPC 4 identifier
  97. 1.2Suffix to the authorisation number
  98. 1.3Product type(s)
  99. META SPC 4 COMPOSITION
  100. 2.1Qualitative and quantitative information on the composition of the meta SPC 4
  101. 2.2Type(s) of formulation of the meta SPC 4
  102. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
  103. AUTHORISED USE(S) OF THE META SPC 4
  104. 4.1Use description
  105. Use-specific instructions for use
  106. For disinfection of the teats:
  107. 4.1.2Use-specific risk mitigation measures
  108. 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
  109. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  110. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  111. 4.2Use description
  112. Use-specific instructions for use
  113. For disinfection of the skin:
  114. 4.2.2Use-specific risk mitigation measures
  115. 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
  116. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  117. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  118. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
  119. 5.1Instructions for use
  120. 5.2Risk mitigation measures
  121. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  122. 5.4Instructions for safe disposal of the product and its packaging
  123. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  124. OTHER INFORMATION
  125. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
  126. 7.1Trade name(s), authorisation number and specific composition of each individual product
  127. META SPC 5
  128. META SPC 5 ADMINISTRATIVE INFORMATION
  129. 1.1Meta SPC 5 identifier
  130. 1.2Suffix to the authorisation number
  131. 1.3Product type(s)
  132. META SPC 5 COMPOSITION
  133. 2.1Qualitative and quantitative information on the composition of the meta SPC 5
  134. 2.2Type(s) of formulation of the meta SPC 5
  135. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
  136. AUTHORISED USE(S) OF THE META SPC 5
  137. 4.1Use description
  138. 4.1.1Use-specific instructions for use
  139. 4.1.2Use-specific risk mitigation measures
  140. 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
  141. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  142. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  143. GENERAL DIRECTIONS FOR USE OF THE META SPC 5
  144. 5.1Instructions for use
  145. 5.2Risk mitigation measures
  146. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  147. 5.4Instructions for safe disposal of the product and its packaging
  148. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  149. OTHER INFORMATION
  150. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
  151. 7.1Trade name(s), authorisation number and specific composition of each individual product
  152. 7.2Trade name(s), authorisation number and specific composition of each individual product
  153. META SPC 6
  154. META SPC 6 ADMINISTRATIVE INFORMATION
  155. 1.1Meta SPC 6 identifier
  156. 1.2Suffix to the authorisation number
  157. 1.3Product type(s)
  158. META SPC 6 COMPOSITION
  159. 2.1Qualitative and quantitative information on the composition of the meta SPC 6
  160. 2.2Type(s) of formulation of the meta SPC 6
  161. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
  162. AUTHORISED USE(S) OF THE META SPC 6
  163. 4.1Use description
  164. 4.1.1Use-specific instructions for use
  165. 4.1.2Use-specific risk mitigation measures
  166. 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
  167. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  168. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  169. GENERAL DIRECTIONS FOR USE OF THE META SPC 6
  170. 5.1Instructions for use
  171. 5.2Risk mitigation measures
  172. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  173. 5.4Instructions for safe disposal of the product and its packaging
  174. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  175. OTHER INFORMATION
  176. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
  177. 7.1Trade name(s), authorisation number and specific composition of each individual product
  178. META SPC 7
  179. META SPC 7 ADMINISTRATIVE INFORMATION
  180. 1.1Meta SPC 7 identifier
  181. 1.2Suffix to the authorisation number
  182. 1.3Product type(s)
  183. META SPC 7 COMPOSITION
  184. 2.1Qualitative and quantitative information on the composition of the meta SPC 7
  185. 2.2Type(s) of formulation of the meta SPC 7
  186. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
  187. AUTHORISED USE(S) OF THE META SPC 7
  188. 4.1Use description
  189. 4.1.1Use-specific instructions for use
  190. 4.1.2Use-specific risk mitigation measures
  191. 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
  192. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  193. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  194. 4.2Use description
  195. 4.2.1Use-specific instructions for use
  196. 4.2.2Use-specific risk mitigation measures
  197. 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
  198. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  199. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  200. GENERAL DIRECTIONS FOR USE OF THE META SPC 7
  201. 5.1Instructions for use
  202. 5.2Risk mitigation measures
  203. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  204. 5.4Instructions for safe disposal of the product and its packaging
  205. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  206. OTHER INFORMATION
  207. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7
  208. 7.1Trade name(s), authorisation number and specific composition of each individual product
  209. META SPC 8
  210. META SPC 8 ADMINISTRATIVE INFORMATION
  211. 1.1Meta SPC 8 identifier
  212. 1.2Suffix to the authorisation number
  213. 1.3Product type(s)
  214. META SPC 8 COMPOSITION
  215. 2.1Qualitative and quantitative information on the composition of the meta SPC 8
  216. 2.2Type(s) of formulation of the meta SPC 8
  217. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
  218. AUTHORISED USE(S) OF THE META SPC 8
  219. 4.1Use description
  220. 4.1.1Use-specific instructions for use
  221. 4.1.2Use-specific risk mitigation measures
  222. 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
  223. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  224. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  225. 4.2Use description
  226. 4.2.1Use-specific instructions for use
  227. 4.2.2Use-specific risk mitigation measures
  228. 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
  229. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  230. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  231. GENERAL DIRECTIONS FOR USE OF THE META SPC 8
  232. 5.1Instructions for use
  233. 5.2Risk mitigation measures
  234. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  235. 5.4Instructions for safe disposal of the product and its packaging
  236. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  237. OTHER INFORMATION
  238. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8
  239. 7.1Trade name(s), authorisation number and specific composition of each individual product
  240. META SPC 9
  241. META SPC 9 ADMINISTRATIVE INFORMATION
  242. 1.1Meta SPC 9 identifier
  243. 1.2Suffix to the authorisation number
  244. 1.3Product type(s)
  245. META SPC 9 COMPOSITION
  246. 2.1Qualitative and quantitative information on the composition of the meta SPC 9
  247. 2.2Type(s) of formulation of the meta SPC 9
  248. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9
  249. AUTHORISED USE(S) OF THE META SPC 9
  250. 4.1Use description
  251. 4.1.1Use-specific instructions for use
  252. 4.1.2Use-specific risk mitigation measures
  253. 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
  254. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  255. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  256. GENERAL DIRECTIONS FOR USE OF THE META SPC 9
  257. 5.1Instructions for use
  258. 5.2Risk mitigation measures
  259. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  260. 5.4Instructions for safe disposal of the product and its packaging
  261. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  262. OTHER INFORMATION
  263. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9
  264. 7.1Trade name(s), authorisation number and specific composition of each individual product
  265. META SPC 10
  266. META SPC 10 ADMINISTRATIVE INFORMATION
  267. 1.1Meta SPC 10 identifier
  268. 1.2Suffix to the authorisation number
  269. 1.3Product type(s)
  270. META SPC 10 COMPOSITION
  271. 2.1Qualitative and quantitative information on the composition of the meta SPC 10
  272. 2.2Type(s) of formulation of the meta SPC 10
  273. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10
  274. AUTHORISED USE(S) OF THE META SPC 10
  275. 4.1Use description
  276. 4.1.1Use-specific instructions for use
  277. 4.1.2Use-specific risk mitigation measures
  278. 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
  279. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  280. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  281. GENERAL DIRECTIONS FOR USE OF THE META SPC 10
  282. 5.1Instructions for use
  283. 5.2Risk mitigation measures
  284. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  285. 5.4Instructions for safe disposal of the product and its packaging
  286. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  287. 6OTHER INFORMATION
  288. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 10
  289. 7.1Trade name(s), authorisation number and specific composition of each individual product
  290. META SPC 11
  291. META SPC 11 ADMINISTRATIVE INFORMATION
  292. 1.1Meta SPC 11 identifier
  293. 1.2Suffix to the authorisation number
  294. 1.3Product type(s)
  295. META SPC 11 COMPOSITION
  296. 2.1Qualitative and quantitative information on the composition of the meta SPC 11
  297. 2.2Type(s) of formulation of the meta SPC 11
  298. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11
  299. AUTHORISED USE(S) OF THE META SPC 11
  300. 4.1Use description
  301. 4.1.1Use-specific instructions for use
  302. 4.1.2Use-specific risk mitigation measures
  303. 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
  304. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  305. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  306. GENERAL DIRECTIONS FOR USE OF THE META SPC 11
  307. 5.1Instructions for use
  308. 5.2Risk mitigation measures
  309. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  310. 5.4Instructions for safe disposal of the product and its packaging
  311. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  312. OTHER INFORMATION
  313. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11
  314. 7.1Trade name(s), authorisation number and specific composition of each individual product
  315. META SPC 12
  316. META SPC 12 ADMINISTRATIVE INFORMATION
  317. 1.1Meta SPC 12 identifier
  318. 1.2Suffix to the authorisation number
  319. 1.3Product type(s)
  320. META SPC 12 COMPOSITION
  321. 2.1Qualitative and quantitative information on the composition of the meta SPC 12
  322. 2.2Type(s) of formulation of the meta SPC 12
  323. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12
  324. AUTHORISED USE(S) OF THE META SPC 12
  325. 4.1Use description
  326. 4.1.1Use-specific instructions for use
  327. 4.1.2Use-specific risk mitigation measures
  328. 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
  329. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  330. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  331. GENERAL DIRECTIONS FOR USE OF THE META SPC 12
  332. 5.1Instructions for use
  333. 5.2Risk mitigation measures
  334. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  335. 5.4Instructions for safe disposal of the product and its packaging
  336. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  337. OTHER INFORMATION
  338. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 12
  339. 7.1Trade name(s), authorisation number and specific composition of each individual product
  340. 7.2Trade name(s), authorisation number and specific composition of each individual product