PPP EU Data Requirements

Environmental Fate and Behaviour

Plant protection products (PPP) and active substances are regulated in the EU by the Commission Regulation (EC) No. 1107/2009 in a two stage market authorisation process.  The active component against pests/plant diseases (the “active substance”) is assessed at EU level in a process involving the EU member states, EFSA and the Commission.  The formulation containing an EU approved active substance (i.e. the plant protection product) is assessed at national/zonal level.  Data requirements for assessing the safety of the active substance are presented in Regulation (EU) No. 283/2013.  Section 7 deals with the data requirements for assessing the environmental fate and behaviour of the active substance. The corresponding data requirements for assessing the safety and effectiveness of the plant protection product are specified in Regulation (EU) No 284/2013.  Section 9 specifies the requirements for assessing the environmental fate and behaviour of the product.  The Commission Communication (2013/C 95/02) provides the list of test methods and guidance documents relevant to the implementation of the Regulation.  Section 9 deals with environmental fate and behaviour.  Applicants are advised to consider all available guidance when preparing submissions.  The latest guidance and models at the time of dossier submission must be applied. 

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