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Commission Implementing Regulation (EU) 2018/1288 of 24 September 2018 granting a Union authorisation for the biocidal product family Prodhynet's iodine based products (Text with EEA relevance)

EU Regulation 2018/1288 · Adopted 24 September 2018 · Extends to United Kingdom

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Commission Implementing Regulation (EU) 2018/1288

of 24 September 2018

granting a Union authorisation for the biocidal product family Prodhynet'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 3 August 2015, Prodhynet SA submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013f2 for authorisation of a same biocidal product family, as referred to in Article 1 of Regulation (EU) No 414/2013, named Prodhynet's iodine based products (‘the same product family’) of product-type 3, as described in Annex V to Regulation (EU) No 528/2012. The application for the same product family was recorded under the case number BC-YK019030-42 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference product family (Hypred's iodine based products), recorded in the Register under the case number BC-LC018584-49.

(2)

The same 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) 2017/2100f3 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 biocidal products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012.

(3)

On 26 January 2018, the Agency submitted to the Commission an opinionf4, including the draft summary of the biocidal product characteristics (‘SPC’), in accordance with Article 6(2) of Regulation (EU) No 414/2013. The opinion concluded that the same product family falls within the definition of ‘biocidal product family’ laid down in Article 3(1)(s) of Regulation (EU) No 528/2012, that the proposed differences between the same product family and the related reference biocidal product family are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013f5, and that based on the assessment of the above-mentioned related reference product family and subject to compliance with the draft SPC, the same product family meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.

(4)

On 6 March 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.

(5)

The Commission concurs with the opinion of the Agency and considers therefore appropriate to grant a Union authorisation for the same product family, and to record the SPC in the Register in accordance with Article 71(6) of that Regulation.

(6)

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 Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4).

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).

f4

ECHA opinion of 25 January 2018 on the Union authorisation of the same biocidal product family PRODHYNET'S iodine based products (UBP-C-1177988-02-00/F).

f5

Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).

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