农药风险评价与实施意见 ppt.pptVIP

Environmental risk assessmentfor pesticide registrationin the European Union Outline of the presentation Main structure and procedures of the EU pesticide registration system Approaches to environmental risk assessment of plant protection products Toxicity studies Pesticide fate modelling Criteria for the authorization of plant protection products in the EU Learning from EU experiences – Lessons for China? Main structure and procedures of the EU pesticide registration system Pesticide registration in the European Union Why a harmonized registration system? Work sharing for registrars Reduction of costs for industry Removal of trade barriers by harmonizing legislation Basic structure of EU registration system Dual authorization system: European Community : authorizes active substances Member States: authorize commercial pesticide products First: registration of active substances at EU level (“Annex I”) Second: registration of formulation in one of the Member States Mutual recognition of product authorizations among Member States (in principle) Infrastructure and costs of registering a pesticide in EU Very detailed and comprehensive registration dossier Typical dossier: 50 000 pages Total duration of preparation: 4 – 5 years Execution of environmental tests : 4 – 5 man-years Evaluation of a dossier: 2 – 3 man-years Evaluation of environmental part: 6 man-months Costs of evaluation of a dossier for the a.i.: € 250000 – € 350000 (= 2.5 – 3.5 million Yuan Renminbi) Approaches to environmental risk assessment of plant protection products Environmental risk assessment – principles Definitions (OECD, 2003) Risk – The probability of an adverse effect in an organism, system or (sub) population caused under specified circumstances by exposure to an agent. ? Evaluation of elements of the pesticide dossier is preferably risk-based. Environmental risk assessment – approach in EU Risk estimate Risk estimate Tiered (=step-wise) risk assessment Tiered risk assessment – sc