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Commission Implementing Regulation (EU) 2020/580 of 27 April 2020 granting a Union authorisation for the biocidal product family ‘SOPURCLEAN’ (Text with EEA relevance)

EU Regulation 2020/580 · Adopted 27 April 2020 · Extends to United Kingdom

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Commission Implementing Regulation (EU) 2020/580

of 27 April 2020

granting a Union authorisation for the biocidal product family ‘SOPURCLEAN’

(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 28 August 2015, SOPURA N.V., submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘SOPURCLEAN’ of product-type 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under the case number BC-PJ019489-22 in the Register for Biocidal Products.

(2)

‘SOPURCLEAN’ contains octanoic acid and decanoic acid, as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.

(3)

On 15 December 2017, 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 15 July 2019, the Agency submitted to the Commission an opinionf2, including the draft summary of the biocidal product characteristics (‘SPC’) of ‘SOPURCLEAN’ 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 ‘SOPURCLEAN’ 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 26 July 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.

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘SOPURCLEAN’.

(8)

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 26 June 2019 on the Union authorisation of ‘SOPURCLEAN’ (ECHA/BPC/227/2019), https://echa.europa.eu/bpc-opinions-on-union-authorisation.

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. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
  39. 5.1Instructions for use
  40. 5.2Risk mitigation measures
  41. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  42. 5.4Instructions for safe disposal of the product and its packaging
  43. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  44. 6OTHER INFORMATION
  45. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
  46. 7.1Trade name(s), authorisation number and specific composition of each individual product
  47. 7.2Trade name(s), authorisation number and specific composition of each individual product
  48. 7.3Trade name(s), authorisation number and specific composition of each individual product
  49. 7.4Trade name(s), authorisation number and specific composition of each individual product
  50. 7.5Trade name(s), authorisation number and specific composition of each individual product
  51. META SPC 2
  52. META SPC 2 ADMINISTRATIVE INFORMATION
  53. 1.1Meta SPC 2 identifier
  54. 1.2Suffix to the authorisation number
  55. 1.3Product type(s)
  56. META SPC 2 COMPOSITION
  57. 2.1Qualitative and quantitative information on the composition of the meta SPC 2
  58. 2.2Type(s) of formulation of the meta SPC 2
  59. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
  60. AUTHORISED USE(S) OF THE META SPC 2
  61. 4.1Use description
  62. 4.1.1Use-specific instructions for use
  63. 4.1.2Use-specific risk mitigation measures
  64. 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
  65. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  66. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  67. 4.2Use description
  68. 4.2.1Use-specific instructions for use
  69. 4.2.2Use-specific risk mitigation measures
  70. 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
  71. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  72. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  73. 4.3Use description
  74. 4.3.1Use-specific instructions for use
  75. 4.3.2Use-specific risk mitigation measures
  76. 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
  77. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  78. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  79. 4.4Use description
  80. 4.4.1Use-specific instructions for use
  81. 4.4.2Use-specific risk mitigation measures
  82. 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
  83. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  84. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  85. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
  86. 5.1Instructions for use
  87. 5.2Risk mitigation measures
  88. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  89. 5.4Instructions for safe disposal of the product and its packaging
  90. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  91. 6OTHER INFORMATION
  92. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
  93. 7.1Trade name(s), authorisation number and specific composition of each individual product
  94. META SPC 3
  95. META SPC 3 ADMINISTRATIVE INFORMATION
  96. 1.1Meta SPC 3 identifier
  97. 1.2Suffix to the authorisation number
  98. 1.3Product type(s)
  99. META SPC 3 COMPOSITION
  100. 2.1Qualitative and quantitative information on the composition of the meta SPC 3
  101. 2.2Type(s) of formulation of the meta SPC 3
  102. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
  103. AUTHORISED USE(S) OF THE META SPC 3
  104. 4.1Use description
  105. 4.1.1Use-specific instructions for use
  106. 4.1.2Use-specific risk mitigation measures
  107. 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
  108. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  109. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  110. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
  111. 5.1Instructions for use
  112. 5.2Risk mitigation measures
  113. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  114. 5.4Instructions for safe disposal of the product and its packaging
  115. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  116. 6OTHER INFORMATION
  117. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
  118. 7.1Trade name(s), authorisation number and specific composition of each individual product
  119. META SPC 4
  120. META SPC 4 ADMINISTRATIVE INFORMATION
  121. 1.1Meta SPC 4 identifier
  122. 1.2Suffix to the authorisation number
  123. 1.3Product type(s)
  124. META SPC 4 COMPOSITION
  125. 2.1Qualitative and quantitative information on the composition of the meta SPC 4
  126. 2.2Type(s) of formulation of the meta SPC 4
  127. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
  128. AUTHORISED USE(S) OF THE META SPC 4
  129. 4.1Use description
  130. 4.1.1Use-specific instructions for use
  131. 4.1.2Use-specific risk mitigation measures
  132. 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
  133. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  134. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  135. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
  136. 5.1Instructions for use
  137. 5.2Risk mitigation measures
  138. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  139. 5.4Instructions for safe disposal of the product and its packaging
  140. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  141. 6OTHER INFORMATION
  142. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
  143. 7.1Trade name(s), authorisation number and specific composition of each individual product