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Bform Information on the chemical biocidal product对化学杀菌品B的信息
B-form: Information on the chemical biocidal product
All the points in the form should be filled with information. In cases where the data requirement is not covered by a study/report, a detailed justification should be given.
Further information can be found in the Technical Notes for Guidance (TNsG) on Data Requirements. Consider in particular chapter 2 and 3 (Common core data set for active substances and biocidal products), Part B (Biocidal products).
For guidance on exposure estimates for livestock, see the guidance document Guidance on Estimating Livestock Exposure to Active Substances used in Biocidal Products which is available via the European Commissions website for biocidal products (DG Environment). For guidance on the assessment of MRLs (Maximum Residue Limits) please refer to the guidance document Risk characterisation and assessment of Maximum Residue Limits (MRLs) for Biocides at the European Medicines Agency’s (EMA) website.
If you have questions, please contact the Swedish Chemicals Agency at: biocider@kemi.se
Point Data requirement Information/value Reference to the application Reference in the TNsG on Data Requirements B1. General information B1.1 Name of the product
B1.2 Product manufacturer
State name or company
B1.3 Production plant(s)
State address(es) of all production plants
B2. Specific information on the product Chapter 2, part B B2.1 Active substance(s) in the product
State chemical name of each active substance in the product
B2.2 Physical state of the product
State the formulation type according to GIFAP-codes. See table B in the end of this document
B2.3 Detailed quantitative and qualitative information on the composition of the product
Fill in the quantitative and qualitative information on the composition of the product. State active substance(s), impurities, adjuvants, inert ingredients etc. State for each constituent an unambiguous
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