Dossier 1


Dossier 1 :

An application dossier is a package of information prepared by the applicant, which contains all of the data required by the EU Commission and Member States in order to evaluate an application for inclusion on the Union list of approved active substances or authorisation of a biocidal product. The dossier is made up of 4 documents termed Document I, II, III and IV plus several appendices which cover claims for confidentiality, references, literature searches etc. Documents II, III and IV are further split into 'A' and 'B' categories for the active substance and associated product(s) respectively. Document I - is the application form with appendices (lists of end points, standard terms and abbreviations, completeness check forms, safety data sheets, overall summary and conclusions, proposal for decision). Document II -risk assessment. Document III - study summaries. Document IV - the original and study reports. EC Classification: The Chemicals (Hazard Information and Packaging for Supply) (CHIP) Regulations and The Dangerous Preparations Directive (99/45/EC) stipulate how a product should be classified. Examples of EC classifications can range from not classified to carcinogen, corrosive, explosive, flammable, harmful, etc. Some of these have accompanying hazard symbols that must also be displayed on product labels. Please consult the regulations for a complete list of the classifications and hazard symbols

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