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Commission Implementing Regulation (EU) 2020/1991 of 27 November 2020 granting a Union authorisation for the biocidal product family ‘perform-IPA’ (Text with EEA relevance)

EU Regulation 2020/1991 · Adopted 27 November 2020 · Extends to United Kingdom

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Commission Implementing Regulation (EU) 2020/1991

of 27 November 2020

granting a Union authorisation for the biocidal product family ‘perform-IPA’

(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 19 April 2016, Schuelke & Mayr GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘perform-IPA’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-AB023095-72 in the Register for Biocidal Products.

(2)

‘perform-IPA’ contains propan-2-ol, 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.

(3)

On 27 August 2019, 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 7 April 2020, the Agency submitted to the Commission an opinionf2, the draft summary of the biocidal product characteristics (‘SPC’) of ‘perform-IPA’ 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 ‘perform-IPA’ 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 27 April 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 ‘perform-IPA’.

(8)

According to the opinion of the Agency, as regards the non-active substance diethyl phthalate contained in ‘perform-IPA’, it was not possible to conclude whether it meets the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100f3 within the period for the evaluation of the application. Further examination of diethyl phthalate should therefore take place. If it is concluded that diethyl phthalate is considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘perform-IPA’ 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

ECHA opinion of 5 March 2020 on the Union authorisation of ‘perform-IPA’ (ECHA/BPC/245/2020), https://echa.europa.eu/bpc-opinions-on-union-authorisation

f3

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).

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. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
  51. 5.1Instructions for use
  52. 5.2Risk mitigation measures
  53. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  54. 5.4Instructions for safe disposal of the product and its packaging
  55. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  56. 6OTHER INFORMATION
  57. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
  58. 7.1Trade name(s), authorisation number and specific composition of each individual product
  59. META SPC 2
  60. META SPC 2 ADMINISTRATIVE INFORMATION
  61. 1.1Meta SPC 2 identifier
  62. 1.2Suffix to the authorisation number
  63. 1.3Product type(s)
  64. META SPC 2 COMPOSITION
  65. 2.1Qualitative and quantitative information on the composition of the meta SPC 2
  66. 2.2Type(s) of formulation of the meta SPC 2
  67. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
  68. AUTHORISED USE(S) OF THE META SPC 2
  69. 4.1Use description
  70. 4.1.1Use-specific instructions for use
  71. 4.1.2Use-specific risk mitigation measures
  72. 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
  73. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  74. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  75. 4.2Use description
  76. 4.2.1Use-specific instructions for use
  77. 4.2.2Use-specific risk mitigation measures
  78. 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
  79. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  80. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  81. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
  82. 5.1Instructions for use
  83. 5.2Risk mitigation measures
  84. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  85. 5.4Instructions for safe disposal of the product and its packaging
  86. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  87. 6OTHER INFORMATION
  88. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
  89. 7.1Trade name(s), authorisation number and specific composition of each individual product
  90. META SPC 3
  91. META SPC 3 ADMINISTRATIVE INFORMATION
  92. 1.1Meta SPC 3 identifier
  93. 1.2Suffix to the authorisation number
  94. 1.3Product type(s)
  95. META SPC 3 COMPOSITION
  96. 2.1Qualitative and quantitative information on the composition of the meta SPC 3
  97. 2.2Type(s) of formulation of the meta SPC 3
  98. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
  99. AUTHORISED USE(S) OF THE META SPC 3
  100. 4.1Use description
  101. 4.1.1Use-specific instructions for use
  102. 4.1.2Use-specific risk mitigation measures
  103. 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
  104. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  105. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  106. 4.2Use description
  107. 4.2.1Use-specific instructions for use
  108. 4.2.2Use-specific risk mitigation measures
  109. 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
  110. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  111. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  112. 4.3Use description
  113. 4.3.1Use-specific instructions for use
  114. 4.3.2Use-specific risk mitigation measures
  115. 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
  116. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  117. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  118. 4.4Use description
  119. 4.4.1Use-specific instructions for use
  120. 4.4.2Use-specific risk mitigation measures
  121. 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
  122. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  123. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  124. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
  125. 5.1Instructions for use
  126. 5.2Risk mitigation measures
  127. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  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. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
  156. 5.1Instructions for use
  157. 5.2Risk mitigation measures
  158. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  159. 5.4Instructions for safe disposal of the product and its packaging
  160. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  161. 6OTHER INFORMATION
  162. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
  163. 7.1Trade name(s), authorisation number and specific composition of each individual product
  164. META SPC 5
  165. META SPC 5 ADMINISTRATIVE INFORMATION
  166. 1.1Meta SPC 5 identifier
  167. 1.2Suffix to the authorisation number
  168. 1.3Product type(s)
  169. META SPC 5 COMPOSITION
  170. 2.1Qualitative and quantitative information on the composition of the meta SPC 5
  171. 2.2Type(s) of formulation of the meta SPC 5
  172. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
  173. AUTHORISED USE(S) OF THE META SPC 5
  174. 4.1Use description
  175. 4.1.1Use-specific instructions for use
  176. 4.1.2Use-specific risk mitigation measures
  177. 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
  178. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  179. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  180. 4.2Use description
  181. 4.2.1Use-specific instructions for use
  182. 4.2.2Use-specific risk mitigation measures
  183. 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
  184. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  185. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  186. GENERAL DIRECTIONS FOR USE OF THE META SPC 5
  187. 5.1Instructions for use
  188. 5.2Risk mitigation measures
  189. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  190. 5.4Instructions for safe disposal of the product and its packaging
  191. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  192. 6OTHER INFORMATION
  193. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
  194. 7.1Trade name(s), authorisation number and specific composition of each individual product
  195. META SPC 6
  196. META SPC 6 ADMINISTRATIVE INFORMATION
  197. 1.1Meta SPC 6 identifier
  198. 1.2Suffix to the authorisation number
  199. 1.3Product type(s)
  200. META SPC 6 COMPOSITION
  201. 2.1Qualitative and quantitative information on the composition of the meta SPC 6
  202. 2.2Type(s) of formulation of the meta SPC 6
  203. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6
  204. AUTHORISED USE(S) OF THE META SPC 6
  205. 4.1Use description
  206. 4.1.1Use-specific instructions for use
  207. 4.1.2Use-specific risk mitigation measures
  208. 4.1.3Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  209. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  210. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  211. 4.2Use description
  212. 4.2.1Use-specific instructions for use
  213. 4.2.2Use-specific risk mitigation measures
  214. 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
  215. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  216. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  217. GENERAL DIRECTIONS FOR USE OF THE META SPC 6
  218. 5.1Instructions for use
  219. 5.2Risk mitigation measures
  220. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  221. 5.4Instructions for safe disposal of the product and its packaging
  222. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  223. 6OTHER INFORMATION
  224. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
  225. 7.1Trade name(s), authorisation number and specific composition of each individual product
  226. META SPC 7
  227. META SPC 7 ADMINISTRATIVE INFORMATION
  228. 1.1Meta SPC 7 identifier
  229. 1.2Suffix to the authorisation number
  230. 1.3Product type(s)
  231. META SPC 7 COMPOSITION
  232. 2.1Qualitative and quantitative information on the composition of the meta SPC 7
  233. 2.2Type(s) of formulation of the meta SPC 7
  234. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7
  235. AUTHORISED USE(S) OF THE META SPC 7
  236. 4.1Use description
  237. 4.1.1Use-specific instructions for use
  238. 4.1.2Use-specific risk mitigation measures
  239. 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
  240. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  241. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  242. 4.2Use description
  243. 4.2.1Use-specific instructions for use
  244. 4.2.2Use-specific risk mitigation measures
  245. 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
  246. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  247. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  248. 4.3Use description
  249. 4.3.1Use-specific instructions for use
  250. 4.3.2Use-specific risk mitigation measures
  251. 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
  252. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  253. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  254. 4.4Use description
  255. 4.4.1Use-specific instructions for use
  256. 4.4.2Use-specific risk mitigation measures
  257. 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
  258. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  259. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  260. GENERAL DIRECTIONS FOR USE OF THE META SPC 7
  261. 5.1Instructions for use
  262. 5.2Risk mitigation measures
  263. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  264. 5.4Instructions for safe disposal of the product and its packaging
  265. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  266. 6OTHER INFORMATION
  267. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7
  268. 7.1Trade name(s), authorisation number and specific composition of each individual product
  269. 7.2Trade name(s), authorisation number and specific composition of each individual product
  270. META SPC 8
  271. META SPC 8 ADMINISTRATIVE INFORMATION
  272. 1.1Meta SPC 8 identifier
  273. 1.2Suffix to the authorisation number
  274. 1.3Product type(s)
  275. META SPC 8 COMPOSITION
  276. 2.1Qualitative and quantitative information on the composition of the meta SPC 8
  277. 2.2Type(s) of formulation of the meta SPC 8
  278. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8
  279. AUTHORISED USE(S) OF THE META SPC 8
  280. 4.1Use description
  281. 4.1.1Use-specific instructions for use
  282. 4.1.2Use-specific risk mitigation measures
  283. 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
  284. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  285. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  286. 4.2Use description
  287. 4.2.1Use-specific instructions for use
  288. 4.2.2Use-specific risk mitigation measures
  289. 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
  290. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  291. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  292. GENERAL DIRECTIONS FOR USE OF THE META SPC 8
  293. 5.1Instructions for use
  294. 5.2Risk mitigation measures
  295. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  296. 5.4Instructions for safe disposal of the product and its packaging
  297. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  298. 6OTHER INFORMATION
  299. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8
  300. 7.1Trade name(s), authorisation number and specific composition of each individual product
  301. 7.2Trade name(s), authorisation number and specific composition of each individual product