About the biological efficacy tests of the products in the Biocidal Products 3rd Main Group, Product Type-14 exceeding 10 years
Announcement from HSGM Regarding Product Type-14 (Biocidal Products Used in Mice and Rat Control)
Brodifacoum, bromodiolone, chlorophacinone, coumatetralyl, difenacoum, difethiolone and flocoumafen active substances are the active substances allowed as active substances in biocidal products under product type 14 used for mouse and rat control in the Biocidal Products Regulation.
In a publication published by the World Health Organization (WHO) in 2006, the amount of active ingredient that should be included in the product is stated instead of the application dose in the products in question.
In this application, where the struggle will continue until the population is taken under control, the application dose is determined according to the density of the population to be combated, due to the feed form of these types of products.
Biological effectiveness tests on the target organism are carried out to prove the effectiveness of the product during the licensing process of biocidal products. At the same time, biological effectiveness studies are conducted every ten years to determine whether the biocidal product creates resistance in the target organism at the application dose determined by WHO.
Chapter 4 article 12 of the Biocidal Product Regulation "The number of tests carried out on vertebrates shall be minimized", "European Biocidal Products Regulation No 528/2012 article 62 "In order to avoid animal testing, testing on vertebrates for the purposes of this Regulation shall only be carried out in the last will be carried out as a remedy" and Directive 2010/63/EU of The European Parliament And of The Council, article 13 states "use a minimum number of animals" in the method selection section in experiments.
Considering the relevant legislative provisions, it has been determined that it is appropriate to perform only physical and chemical analyzes in biological activity studies exceeding ten years, since there is no specified dose range in this product group and only the concentration of the active substance in the product is fixed.