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Commission Implementing Regulation (EU) 2018/1261 of 20 September 2018 granting a Union authorisation for the biocidal product family Hypred's iodine based products (Text with EEA relevance)

EU Regulation 2018/1261 · Adopted 20 September 2018 · Extends to United Kingdom

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Commission Implementing Regulation (EU) 2018/1261

of 20 September 2018

granting a Union authorisation for the biocidal product family Hypred's iodine based products

(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 16 July 2015, Hypred SAS submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named Hypred's iodine based products (‘the product family’) of product-type 3, as defined in Annex V to that Regulation. The Netherlands agreed that their competent authority referred to in Article 43(1) of Regulation (EU) No 528/2012 evaluate this application. The application was recorded under the case number BC-LC018584-49 in the Register for Biocidal Products (‘the Register’).

(2)

The biocidal product family contains iodine as 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, once the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100f2 will become applicable, 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 6 June 2017 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 12 January 2018, the Agency submitted to the Commission an opinionf3, including the draft summary of the biocidal product characteristics (hereinafter ‘SPC’) and the final product assessment report on the product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concluded that the 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 was found eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, the product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(5)

On 26 February 2018, 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 therefore appropriate to grant a Union authorisation for the biocidal product family, and to record the SPC and the product assessment report on the product family in the Register in accordance with Article 71(6) of Regulation (EU) No 528/2012.

(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 12 December 2017 on the Union authorisation of Hypred's iodine based products (ECHA/BPC/178/2017).

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. 7.2Trade name(s), authorisation number and specific composition of each individual product
  42. META SPC 2
  43. META SPC 2 ADMINISTRATIVE INFORMATION
  44. 1.1Meta SPC 2 identifier
  45. 1.2Suffix to the authorisation number
  46. 1.3Product type(s)
  47. META SPC 2 COMPOSITION
  48. 2.1Qualitative and quantitative information on the composition of the meta SPC 2
  49. 2.2Type(s) of formulation of the meta SPC 2
  50. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
  51. AUTHORISED USE(S) OF THE META SPC 2
  52. 4.1Use description
  53. 4.1.1Use-specific instructions for use
  54. 4.1.2Use-specific risk mitigation measures
  55. 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
  56. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  57. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  58. 4.2Use description
  59. 4.2.1Use-specific instructions for use
  60. 4.2.2Use-specific risk mitigation measures
  61. 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
  62. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  63. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  64. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
  65. 5.1Instructions for use
  66. 5.2Risk mitigation measures
  67. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  68. 5.4Instructions for safe disposal of the product and its packaging
  69. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  70. OTHER INFORMATION
  71. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
  72. 7.1Trade name(s), authorisation number and specific composition of each individual product
  73. 7.2Trade name(s), authorisation number and specific composition of each individual product
  74. META SPC 3
  75. META SPC 3 ADMINISTRATIVE INFORMATION
  76. 1.1Meta SPC 3 identifier
  77. 1.2Suffix to the authorisation number
  78. 1.3Product type(s)
  79. META SPC 3 COMPOSITION
  80. 2.1Qualitative and quantitative information on the composition of the meta SPC 3
  81. 2.2Type(s) of formulation of the meta SPC 3
  82. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
  83. AUTHORISED USE(S) OF THE META SPC 3
  84. 4.1Use description
  85. 4.1.1Use-specific instructions for use
  86. 4.1.2Use-specific risk mitigation measures
  87. 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
  88. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  89. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  90. 4.2Use description
  91. 4.2.1Use-specific instructions for use
  92. 4.2.2Use-specific risk mitigation measures
  93. 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
  94. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  95. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  96. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
  97. 5.1Instructions for use
  98. 5.2Risk mitigation measures
  99. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  100. 5.4Instructions for safe disposal of the product and its packaging
  101. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  102. OTHER INFORMATION
  103. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
  104. 7.1Trade name(s), authorisation number and specific composition of each individual product
  105. META SPC 4
  106. META SPC 4 ADMINISTRATIVE INFORMATION
  107. 1.1Meta SPC 4 identifier
  108. 1.2Suffix to the authorisation number
  109. 1.3Product type(s)
  110. META SPC 4 COMPOSITION
  111. 2.1Qualitative and quantitative information on the composition of the meta SPC 4
  112. 2.2Type(s) of formulation of the meta SPC 4
  113. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
  114. AUTHORISED USE(S) OF THE META SPC 4
  115. 4.1Use description
  116. 4.1.1Use-specific instructions for use
  117. 4.1.2Use-specific risk mitigation measures
  118. 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
  119. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  120. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  121. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
  122. 5.1Instructions for use
  123. 5.2Risk mitigation measures
  124. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  125. 5.4Instructions for safe disposal of the product and its packaging
  126. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  127. OTHER INFORMATION
  128. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
  129. 7.1Trade name(s), authorisation number and specific composition of each individual product
  130. META SPC 5
  131. META SPC 5 ADMINISTRATIVE INFORMATION
  132. 1.1Meta SPC 5 identifier
  133. 1.2Suffix to the authorisation number
  134. 1.3Product type(s)
  135. META SPC 5 COMPOSITION
  136. 2.1Qualitative and quantitative information on the composition of the meta SPC 5
  137. 2.2Type(s) of formulation of the meta SPC 5
  138. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
  139. AUTHORISED USE(S) OF THE META SPC 5
  140. 4.1Use description
  141. 4.1.1Use-specific instructions for use
  142. 4.1.2Use-specific risk mitigation measures
  143. 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
  144. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  145. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  146. 4.2Use description
  147. 4.2.1Use-specific instructions for use
  148. 4.2.2Use-specific risk mitigation measures
  149. 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
  150. 4.2.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  151. 4.2.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  152. GENERAL DIRECTIONS FOR USE OF THE META SPC 5
  153. 5.1Instructions for use
  154. 5.2Risk mitigation measures
  155. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  156. 5.4Instructions for safe disposal of the product and its packaging
  157. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  158. OTHER INFORMATION
  159. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
  160. 7.1Trade name(s), authorisation number and specific composition of each individual product