draft commission regulation ec no ... of ... on the second phase of the 10-year work programme referred to in article 16 2 of directive 98 8 ec of the european parliament and of the council concerning the placing of biocidal products on the market and amending regulation ec no 1896 2000. 113 pages available in english text and annexes danish german greek spanish french italian dutch portuguese finnish swedish text only . directive 98 8 ec lays down in article 16 that the commission and the member states have to review all existing active substances in biocidal products within a 10-year programme of work with regard to the safety of their use for human health and the environment with a view of their possible inclusion into annex i or ia to the directive. once the review of an active substance is completed biocidal products containing it will have to be authorised in the member states. according to article 5 of the directive member states can only authorise biocidal products if the active substance or substances is listed in annex i or ia and if the product among others is i sufficiently effective ii has no unacceptable effects on the target organisms such as unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates iii has no unacceptable effects itself or as a result of its residues on human or animal health directly or indirectly through drinking water food or feed indoor air or consequences in the place of work or on surface water or groundwater iv has no unacceptable effect itself or as a result of its residues on the environment having particular regard to the following considerations - its fate and distribution in the environment particularly contamination of surface waters including estuarian and seawater groundwater and drinking water - its impact on non-target organisms v the nature and quantity of its active substances and where appropriate any toxicologically or ecotoxicologically significant impurities and co-formulants and its residues of toxicological or environmental significance which result from authorised uses can be determined according to the relevant requirements in annex iia iib iiia iiib iva or ivb to the directive vi its physical and chemical properties have been determined and deemed acceptable for purposes of the appropriate use storage and transport of the products regulation 1896 2000 established the first phase of this review programme. the new draft regulation establishes all necessary provisions for the second phase. for substances not notified no dossiers will be provided to allow their evaluation. it is therefore not possible to demonstrate that their continued use meets the requirements established by directive 98 8 ec and their marketing and use will have to be phased out after a period of grace of 3 years unless a complete dossier will be prepared during that period of grace. the draft commission regulation provides for the detailed rules for the implementation of the second phase of the programme of work for the systematic examination of all active substances already on the market in biocidal products when directive 98 8 ec entered into force on 14 may 2000 . annex i contains the exhaustive list of existing active substances i.e. those used in biocidal products on 14 may 2000 in the ec . annex ii contains the list of notified existing active substances i.e. those for which operators will prepare comprehensive dossiers allowing for the evaluation of the safety of their use regarding human health and the environment with a view of their inclusion into one of the annexes of the directive. the regulation further lays down all necessary details regarding the submission of dossiers including the schedule for their submission and evaluation annex v . annex iii contains the list of only-identified substances i.e those for which at the current time no operator expressed an interest to prepare a dossier or have them included in the annexes of the directive . marketing and use of these substances for biocidal purposes will have to cease as of 1 september 2006. however if operators deem this necessary in the future they can prepare dossiers for these substances and request inclusion into one of the annexes of the directive at a later stage