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Commission Implementing Regulation (EU) 2019/1794 of 22 October 2019 granting a Union authorisation for the biocidal product family ‘Boumatic Iodine product family’ (Text with EEA relevance)

EU Regulation 2019/1794 · Adopted 22 October 2019 · Extends to United Kingdom

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Commission Implementing Regulation (EU) 2019/1794

of 22 October 2019

granting a Union authorisation for the biocidal product family ‘Boumatic Iodine product family’

(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 21 August 2015, Boumatic Gascoigne Melotte submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Boumatic Iodine product family’ of product-type 3, 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-PG019260-52 in the Register for Biocidal Products.

(2)

The ‘Boumatic Iodine 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 10 April 2018, 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 4 April 2019, the Agency submitted to the Commission an opinionf3, including the draft summary of the biocidal product characteristics (‘SPC’) of the ‘Boumatic Iodine 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 ‘Boumatic Iodine product family’ 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.

(5)

On 20 June 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 ‘Boumatic Iodine 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 27 February 2019 on the Union authorisation of ‘Boumatic Iodine product family’ (ECHA/BPC/220/2019).

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. 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. OTHER 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. 4.3Use description
  82. 4.3.1Use-specific instructions for use
  83. 4.3.2Use-specific risk mitigation measures
  84. 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
  85. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  86. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  87. 4.4Use description
  88. 4.4.1Use-specific instructions for use
  89. 4.4.2Use-specific risk mitigation measures
  90. 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
  91. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  92. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  93. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
  94. 5.1Instructions for use
  95. 5.2Risk mitigation measures
  96. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  97. 5.4Instructions for safe disposal of the product and its packaging
  98. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  99. OTHER INFORMATION
  100. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
  101. 7.1Trade name(s), authorisation number and specific composition of each individual product
  102. 7.2Trade name(s), authorisation number and specific composition of each individual product
  103. META SPC 3
  104. META SPC 3 ADMINISTRATIVE INFORMATION
  105. 1.1Meta SPC 3 identifier
  106. 1.2Suffix to the authorisation number
  107. 1.3Product type(s)
  108. META SPC 3 COMPOSITION
  109. 2.1Qualitative and quantitative information on the composition of the meta SPC 3
  110. 2.2Type(s) of formulation of the meta SPC 3
  111. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
  112. AUTHORISED USE(S) OF THE META SPC 3
  113. 4.1Use description
  114. 4.1.1Use-specific instructions for use
  115. 4.1.2Use-specific risk mitigation measures
  116. 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
  117. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  118. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  119. 4.2Use description
  120. 4.2.1Use-specific instructions for use
  121. 4.2.2Use-specific risk mitigation measures
  122. 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
  123. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  124. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  125. 4.3Use description
  126. 4.3.1Use-specific instructions for use
  127. 4.3.2Use-specific risk mitigation measures
  128. 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
  129. 4.3.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  130. 4.3.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  131. 4.4Use description
  132. 4.4.1Use-specific instructions for use
  133. 4.4.2Use-specific risk mitigation measures
  134. 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
  135. 4.4.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  136. 4.4.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  137. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
  138. 5.1Instructions for use
  139. 5.2Risk mitigation measures
  140. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  141. 5.4Instructions for safe disposal of the product and its packaging
  142. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  143. OTHER INFORMATION
  144. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
  145. 7.1Trade name(s), authorisation number and specific composition of each individual product