LAW ON BIOCIDAL PRODUCTS

methods of detection, identification and analysis; data on toxicological and eco-toxicologicalproperties, data on effectiveness against target organisms and intended uses, data on measuresnecessary to protect humans, animals and environment, data on classification, labelling andpackaging as well as summary of the Technical Dossier.The Technical Dossier for low-risk biocidal product contains data on active substanceand biocidal product, in particular: identity, data on physical and chemical properties, data onintended use, data on effectiveness against target organisms, data on methods of detection,identification and analysis, as well as data on classification, labelling and packaging.Technical dossier from Paragraphs 2 and 3 of this Article shall contain full descriptionof the studies conducted or a bibliographical reference to those data.If some of the data referred to in Paragraphs 2 and 3 of this Article are not necessary tobe provided owing to the nature of the biocidal product or of its proposed uses or if testing forthe purpose of data delivery is not scientifically necessary or technically possible, justificationin written form must be submitted.Instead of the Technical Dossier, or certain parts of the Technical Dossier consent foruse of such data may be submitted by a person who already submitted Technical Dossier tothe Agency for similar biocidal product.Along with the consent from Paragraph 6 of this Article, evidence that variations inthe composition of the biocidal product are in accordance with acceptable variations set out inthe frame formulation shall be presented.Data from the Technical Dossier may be used for the same or similar biocidal producteven without the consent from Paragraph 6 of this Article, within the deadlines laid down bythe Agency, and in such case the evidence that the biocidal product is the same or evidencefrom Paragraph 7 of this Article shall be submitted.The Agency shall lay down the scope and the content of the Technical Dossier for thebiocidal product i.e. low-risk biocidal product.Article 14Test methods laid down in the Law on Chemicals shall be applied for obtaining of thedata on physical, chemical, toxicological and eco-toxicological properties of the activesubstance and biocidal product necessary for the Technical Dossier.Internationally accepted and harmonised test methods shall be used, where the testmethod from paragraph 1 of this Article is inappropriate, i.e. nonexistent.If methods referred to in Paragraph 1 of this Article are not used for testing, theadequacy of such methods shall be verified for every single test, taking into account theminimisation of the testing on vertebrates.New testing of the active substance and biocidal product shall be carried out in thelaboratory whose work is harmonised with the principles of Good Laboratory Practice.Testing of the efficacy of the active substance and biocidal product shall be carried outin the laboratory with quality control and quality insurance.The Agency shall lay down test methods for the efficacy of the active substance andbiocidal product.6