LAW ON BIOCIDAL PRODUCTS

3. it is established, in the light of current scientific and technical knowledge thatbiocidal product, when used under normal conditions:- is sufficiently effective;- has no unacceptable effects on the target organisms, such as unacceptableresistance or cross-resistance or unnecessary suffering or pain of vertebrates;- has no unacceptable effects itself, or as a result of its residues, on human or animalhealth, directly or indirectly (e.g. through drinking water, indoor air or the work place)or on surface and ground-waters;- has no unacceptable effects itself, or as the result of its residues, on the environmenthaving particular regard to its fate and distribution in the environment, particularlycontamination of surface, ground and drinking water, as well as its impact on nontarget organisms;4. its physical and chemical properties have beed determined and deemed acceptablefor purpose of appropriate use, storage and transport.The condition referred to in Point 3, Paragraph 1 of this Article shall be taken intoconsideration for the intended use of the material treated with that biocidal product.When carrying out assessment of the biocidal product from Paragraph 1, the Agencyshall take into consideration requirements determined by other legal acts regulating health andsafety at work, consumer’s protection, animal health and environmental protection.Article 18The Agency shall, within one year from the day of submitting of the application forauthorisation and complete Technical Dossier, i.e. 60 days for low-risk biocidal product andfor biocidal product within the established frame formulation, issue the authorisation.The authorisation shall contain: data on the applicant; trade name of the biocidalproduct; name and content of the active substances and other substances contained in thebiocidal product whose concentration does not affect the efficacy and classification of thebiocidal product; biocidal product type and conditions for placing on the market and use;period of validity of the authorisation as well as other data.Conditions for placing on the market and use of the biocidal product from Paragraph 2of this Article may for example be: authorised uses, manner of storage and keeping, retailer’sfacilities depending on the properties and biocidal product type etc.The authorisation shall be issued for the period of 10 years or for the period for whichactive substance contained in that biocidal product is included into the List I – List of activesubstances, List Ia – List of active substance contained in low-risk biocidal product.Against the Decision on authorisation from Paragraph 1 of this Article, an appeal maybe lodged to the Minster.Decision from Paragraph 1 of this Article shall be final and administrative procedureagainst it may be initiated.Article 19Person with the intention to carry out experiments involving vertebrates for thepurpose of preparing of the Technical Dossier for the biocidal product shall require from the8