EU Central Zone Requirements (PPP)

Environmental fate and behaviour

The Central zone Members States (Austria, Belgium, Czech Republic, Germany, Hungary, Ireland, Luxembourg, the Netherlands, Poland, Romania, Slovak Republic and Republic of Slovenia) have agreed a procedure for the assessment of the Environmental fate and behaviour section of plant protection product application/dossiers for authorisation /re-authorisation following Annex I inclusion of an active substance under Directive 91/414/EEC or its approval under Regulation (EC) No. 1107/2009 in the Central zone.  Please refer to the “Working document of the Central Zone in the Authorisation of Plant Protection Products, Section 8, Environmental Fate and Behaviour Version 1 rev. 1 – June 2018” for further details.  This document is NOT intended to produce legally binding effects and by its nature does NOT prejudice any measure taken by a Member State/country within the implementation prerogatives under Annex II, III and VI of Council Directive 91/414/EEC or subsequently Regulation (EC) No. 1107/2009, nor any case law developed with regard to these provisions. This document also does not preclude the possibility that the European Court of Justice may give one or another provision direct effect in Member States.  The Guidance document is updated from time to time to take account of regulatory developments, (e.g. new data requirements and/or guidance on risk assessment, risk mitigation measures) and practical experience of the procedures.  Applicants should ensure they have the latest version of the guidance document.


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