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Commission Implementing Regulation (EU) 2020/1995 of 4 December 2020 amending Implementing Regulation (EU) No 2018/1261 as regards administrative changes of the information related to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’ (Text with EEA relevance)

EU Regulation 2020/1995 · Adopted 4 December 2020 · Extends to United Kingdom

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Commission Implementing Regulation (EU) 2020/1995

of 4 December 2020

amending Implementing Regulation (EU) No 2018/1261 as regards administrative changes of the information related to the Union authorisation of 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 50(2) thereof,

Whereas:

(1)

On 20 September 2018, a Union authorisation with authorisation number EU-0018397-0000 was granted by Commission Implementing Regulation (EU) 2018/1261f2 to HYPRED SAS for the making available on the market and use of the biocidal product family ‘Hypred’s iodine based products‘.

(2)

On 04 April 2019, HYPRED SAS submitted a notification to the European Chemicals Agency (‘the Agency’), in accordance with Article 11(1) of Commission Implementing Regulation (EU) No 354/2013f3, in respect of administrative changes to the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’ as described in Title 1, Sections 1 and 2 of the Annex to that Regulation.

(3)

HYPRED SAS proposed the following changes to the summary of the product characteristics for the biocidal product family ‘Hypred’s iodine based products’, as set out in the Annex to Implementing Regulation (EU) 2018/1261: (a) the addition of names for the biocidal product family in Section 7.1 of the third information level: individual products in the meta SPCs 1, 2, 3 and 5; (b) the change of the name of the authorisation holder in Section 1.3; (c) the addition of two manufacturers for the active substance and their respective manufacturing sites in Section 1.5; (d) the change of administrative details of the manufacturer in Section 1.4; (e) changes of administrative details of the location of existing manufacturing sites, and addition of location of new manufacturing sites in Section 1.4. The notification was recorded under case number BC-KC049719-36 in the Register for Biocidal Products.

(4)

On 19 June 2019, the Agency submitted to the Commission an opinion on the proposed changes, in accordance with Article 11(3) of Implementing Regulation (EU) No 354/2013. The opinion concludes that the amendments to the existing authorisation sought by the authorisation holder falls under the category of change set out in Article 50(3)(a) of Regulation (EU) No 528/2012, and that after the implementation of the changes the conditions of Article 19 to that Regulation are still met.

(5)

On 28 June 2019, the Agency transmitted to the Commission the revised summary of the biocidal product characteristics in all the official languages of the Union in accordance with Article 11(6) of Implementing Regulation (EU) No 354/2013.

(6)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to amend the Union authorisation of the biocidal product family ‘Hypred’s iodine based products’.

(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 Implementing Regulation (EU) 2018/1261 of 20 September 2018 granting a Union authorisation for the biocidal product family Hypred’s iodine based products (OJ L 238, 21.9.2018, p. 33).

f3

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. 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