Opinion Of The Scientific Panel On Plant Protection Products And Their Residues On A Request From The Commission Related To The Revision Of Annexes Ii And Iii To Council Directive 91/414/Eec Concerning The Placing Of Plant Protection Products On The Market - Fate And Behaviour In The Environment (Question No Efsa-Q-2006-117) Adopted On 31 January 2007

The PPR Panel was asked to review the Commission Working Document SANCO/10481/2006 rev. 6 on the proposed data requirements for the revision of Directive 96/68/EC (fate and behaviour) within the framework of a revision process involving Part A of Annexes II and III of Directive 91/414/EEC concerning the placing of plant protection products on the market. In particular, the PPR Panel was asked to verify that the proposed methodology and the approaches presented in the draft data requirements are in line with the state of the art and the extent of its applicability to the assessment of risks posed to the ecosystem from the residues of plant protection products, present in time and space following their application.The PPR Panel concluded that this document makes a significant contribution towards improving and better defining the data requirements in line with current scientific understanding and experience of applying the legislation for the evaluation of risks to the ecosystem, non-target organisms, humans and animals used in food production. As a result, new material is included, reflecting advances in science and technology and changes in legislation introduced since the first published edition of Directive 91/414/EEC and its data requirements for Annexes II & III (Directive 95/36/EC).However, the PPR Panel proposes that the document should be revised, taking into consideration the issues identified by the Panel, to improve precision and clarity, avoid inconsistency, and to provide justification for the proposed data requirements.It should always be open to the notifier to submit a reasoned scientific argument as to why a particular study is not needed.As a general rule, the PPR Panel thinks that the data requirements should specify the use of validated test protocols (accepted either by the EU or the OECD) where they are available and fit for purpose. Where no validated method is currently available, notifiers should justify their choice of non-standard tests, and provide details of their performance. Furthermore, should a suitable validated test be developed in the future, this should then be used in preference to non-standard or outdated tests.In particular the requirements for photolysis should be mandatory unless it can be justified that photolysis does not contribute significantly to the transformation of the active substance. Further, there is an urgent need to update and finalise the draft guidelines supporting the data requirements.The PPR Panel has doubts about the interpretation and use of lysimeter studies in leaching risk assessment. However, the FOCUS Groundwater Workgroup is currently preparing further guidance and the Panel looks forward to this.The PPR Panel recognises the importance of field leaching tests for assessing realistic worst case leaching and, although the Panel is aware that some technical aspects will be discussed and reported in the forthcoming FOCUS groundwater report, recommends that official test guidelines be developed.In its opinion adopted on the 30th January, 2003 the Scientific Committee on Plants recommended a check on the scientific validity of the stepwise procedure proposed in the MEDRICE Report, and identified some concerns about the modelling framework. The PPR Panel reminds the Commission of the need to update the MEDRICE Report.The PPR Panel has noted that data requirements on fate and behaviour are connected to other data requirements e.g. on ecotoxicology and residues in following crops and recommends that once all Annexes have been revised, a check on consistency and completeness be performed across all data requirements.In addition the PPR Panel recommends that these Annexes and the others to be revised should include a common glossary of terms to promote consistent use of key terms across the different parts of the new legislation.