NL Storm Ultra PT 14 Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products PRODUCT ASSESSMENT REPORT OF A BIOCIDAL PRODUCT FOR NATIONAL AUTHORISATION APPLICATIONS (submitted by the eCA) Storm Ultra Product type 14 Flocoumafen as included in the Union list of approved active substances Case Number in R4BP: BC-GJ024217-49 Evaluating Competent Authority: The Netherlands Date: 7/12/2018 1 NL Storm Ultra PT 14 Table of Contents 1 CONCLUSION ....................................................................................................................................... 5 2 ASSESSMENT REPORT ..................................................................................................................... 7 2.1 SUMMARY OF THE PRODUCT ASSESSMENT ............................................................................................... 7 2.1.1 ADMINISTRATIVE INFORMATION ........................................................................................................... 7 2.1.1.1 IDENTIFIER OF THE PRODUCT / PRODUCT FAMILY ........................................................................... 7 2.1.1.2 AUTHORISATION HOLDER .................................................................................................................. 7 2.1.1.3 MANUFACTURER(S) OF THE PRODUCT.............................................................................................. 7 2.1.1.4 MANUFACTURER(S) OF THE ACTIVE SUBSTANCE ............................................................................. 7 2.1.2 PRODUCT COMPOSITION AND FORMULATION ...................................................................................... 8 2.1.2.1 IDENTITY OF THE ACTIVE SUBSTANCE .............................................................................................. 8 2.1.2.2 CANDIDATE(S) FOR SUBSTITUTION ................................................................................................. 8 2.1.2.3 QUALITATIVE AND QUANTITATIVE INFORMATION ON THE COMPOSITION OF THE BIOCIDAL PRODUCT 9 2.1.2.4 INFORMATION ON TECHNICAL EQUIVALENCE ................................................................................... 9 2.1.2.5 INFORMATION ON THE SUBSTANCE(S) OF CONCERN ...................................................................... 9 2.1.2.6 TYPE OF FORMULATION ..................................................................................................................... 9 2.1.3 HAZARD AND PRECAUTIONARY STATEMENTS ....................................................................................... 9 2.1.4 AUTHORISED USE(S)........................................................................................................................... 10 2.1.4.1 House mice – general public – indoor ................................................................................................................ 10 2.1.4.2 Use-specific instructions for use ......................................................................................................................... 10 2.1.4.3 Use-specific risk mitigation measures ................................................................................................................ 11 2.1.4.4 Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment......................................................................................................... 11 2.1.4.5 Where specific to the use, the instructions for safe disposal of the product and its packaging ........................ 11 2.1.4.6 Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage ............................................................................................................................................................................ 11 2.1.4.7 Rats – general public – indoor ............................................................................................................................ 11 2.1.4.8 Use-specific instructions for use ......................................................................................................................... 12 2.1.4.9 Use-specific risk mitigation measures ................................................................................................................ 12 2.1.4.10 Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment......................................................................................................... 13 2.1.4.11 Where specific to the use, the instructions for safe disposal of the product and its packaging....................... 13 2.1.4.12 Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage ............................................................................................................................................................................ 13 2.1.4.13 Rats – general public – outdoor around buildings ............................................................................................ 13 2.1.4.14 Use-specific instructions for use ....................................................................................................................... 14 2.1.4.15 Use-specific risk mitigation measures .............................................................................................................. 14 2.1.4.16 Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment......................................................................................................... 14 2.1.4.17 Where specific to the use, the instructions for safe disposal of the product and its packaging....................... 15 2.1.4.18 Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage ............................................................................................................................................................................ 15 2.1.4.19 House mice – professionals – indoor ................................................................................................................ 15 2.1.4.20 Use-specific instructions for use ....................................................................................................................... 15 2.1.4.21 Use-specific risk mitigation measures .............................................................................................................. 16 2.1.4.22 Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment......................................................................................................... 16 2.1.4.23 Where specific to the use, the instructions for safe disposal of the product and its packaging....................... 16 2.1.4.24 Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage ............................................................................................................................................................................ 16 2.1.4.25 Rats – professionals– indoor ............................................................................................................................ 16 2.1.4.26 Use-specific instructions for use ....................................................................................................................... 17 2.1.4.27 Use-specific risk mitigation measures .............................................................................................................. 17 2 NL Storm Ultra PT 14 2.1.4.28 Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment......................................................................................................... 17 2.1.4.29 Where specific to the use, the instructions for safe disposal of the product and its packaging....................... 17 2.1.4.30 Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage ............................................................................................................................................................................ 17 2.1.4.31 House mice and rats – professionals – outdoor around buildings.................................................................... 17 2.1.4.32 Use-specific instructions for use ....................................................................................................................... 18 2.1.4.33 Use-specific risk mitigation measures .............................................................................................................. 19 2.1.4.34 Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment......................................................................................................... 19 2.1.4.35 Where specific to the use, the instructions for safe disposal of the product and its packaging......................