ANNEX to SANCO 11802-2010 Rev. 2 - European ….doc

D021893/02 EN PAGE \* MERGEFORMAT 1 DOCVARIABLE "LW_Confidence" \* MERGEFORMAT Error! No document variable supplied. EN ANNEX to SANCO/11802/2010 Rev. 3 "ANNEX INTRODUCTION Information to be submitted, its generation and its presentation 1. The information submitted shall meet the following requirements. 1.1. The information shall be sufficient to evaluate the foreseeable risks, whether immediate or delayed, which the active substance may entail for humans, including vulnerable groups, animals and the environment and contain at least the information and results of the studies referred to in this Annex. 1.2. Any information on potentially harmful effects of the active substance, its metabolites and impurities on human and animal health or on groundwater shall be included. 1.3. Any information on potentially unacceptable effects of the active substance, its metabolites and impurities on the environment, on plants and plant products shall be included. 1.4. The information shall include all relevant data from the scientific peer reviewed open literature on the active substance, metabolites and breakdown or reaction products and plant protection products containing the active substance and dealing with side-effects on health, the environment and non-target species. A summary of this data shall be provided. 1.5. The information shall include a full and unbiased report of the studies conducted as well as a full description of them. Such information shall not be required, where one of the following conditions is fulfilled: it is not necessary owing to the nature of the product or its proposed uses, or it is not scientifically necessary; it is technically not possible to supply. In such a case a justification shall be provided. 1.6. The simultaneous use of the active substance as a biocide or in veterinary medicine shall be reported. If the applicant for the active substance in the plant protection product is identical to the one responsible for the notification of the a