OpenLegislation

Commission Implementing Regulation (EU) 2020/579 of 27 April 2020 granting a Union authorisation for the biocidal product family ‘HYPRED’s octanoic acid based products’ (Text with EEA relevance)

EU Regulation 2020/579 · Adopted 27 April 2020 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Commission Implementing Regulation (EU) 2020/579

of 27 April 2020

granting a Union authorisation for the biocidal product family ‘HYPRED’s octanoic acid 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 the first subparagraph of Article 44(5) thereof,

Whereas:

(1)

On 25 August 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 octanoic acid based products’ of product-type 4, 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 the case number BC-LR019297-17 in the Register for Biocidal Products.

(2)

‘HYPRED‘s octanoic acid based products’ contains octanoic acid, 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.

(3)

On 19 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 11 July 2019, the Agency submitted to the Commission an opinionf2, including the draft summary of the biocidal product characteristics (‘SPC’) of ‘HYPRED‘s octanoic acid based products’ 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 ‘HYPRED‘s octanoic acid based products’ 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 25 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 ‘HYPRED‘s octanoic acid based products’.

(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 ‘HYPRED‘s octanoic acid based products’ (ECHA/BPC/226/2019), 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. META SPC 2
  48. META SPC 2 ADMINISTRATIVE INFORMATION
  49. 1.1Meta SPC 2 identifier
  50. 1.2Suffix to the authorisation number
  51. 1.3Product type(s)
  52. META SPC 2 COMPOSITION
  53. 2.1Qualitative and quantitative information on the composition of the meta SPC 2
  54. 2.2Type(s) of formulation of the meta SPC 2
  55. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
  56. AUTHORISED USE(S) OF THE META SPC 2
  57. 4.1Use description
  58. 4.1.1Use-specific instructions for use
  59. 4.1.2Use-specific risk mitigation measures
  60. 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
  61. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  62. 4.1.5Where 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 3 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. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
  89. 5.1Instructions for use
  90. 5.2Risk mitigation measures
  91. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  92. 5.4Instructions for safe disposal of the product and its packaging
  93. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  94. OTHER INFORMATION
  95. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
  96. 7.1Trade name(s), authorisation number and specific composition of each individual product
  97. META SPC 4
  98. META SPC 4 ADMINISTRATIVE INFORMATION
  99. 1.1Meta SPC 4 identifier
  100. 1.2Suffix to the authorisation number
  101. 1.3Product type(s)
  102. META SPC 4 COMPOSITION
  103. 2.1Qualitative and quantitative information on the composition of the meta SPC 4
  104. 2.2Type(s) of formulation of the meta SPC 4
  105. 3HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
  106. AUTHORISED USE(S) OF THE META SPC 4
  107. 4.1Use description
  108. 4.1.1Use-specific instructions for use
  109. 4.1.2Use-specific risk mitigation measures
  110. 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
  111. 4.1.4Where specific to the use, the instructions for safe disposal of the product and its packaging
  112. 4.1.5Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
  113. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
  114. 5.1Instructions for use
  115. 5.2Risk mitigation measures
  116. 5.3Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
  117. 5.4Instructions for safe disposal of the product and its packaging
  118. 5.5Conditions of storage and shelf-life of the product under normal conditions of storage
  119. 6OTHER INFORMATION
  120. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
  121. 7.1Trade name(s), authorisation number and specific composition of each individual product