Dec 9th, 2016
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  1. Dear Dr Flüh
  2. Dear ScoPAFF members
  4. Ahead of the SCoPAFF-phytopharmaceutical of 6-7 December, ECPA would like to take this
  5. opportunity to provide our input on a number of current issues. Reference is made to the
  6. meeting agenda item where relevant:
  8. Endocrine disruption (Agenda item A.18)
  10. ECPA would underline the concerns we have with the proposal for the criteria for endocrine
  11. disruptors. For decision making under Regulation 1107/2009, we believe regulators should
  12. be provided with the necessary tools to separate out those substances which have the real
  13. potential to cause harm, from those that do not. It remains our firm view that endocrine
  14. disruptors can and should be regulated like other substances of potential concern and be
  15. subject to risk assessment considering both hazard and exposure. A departure from this
  16. framework sets a precedent for regulation that neglects the consideration of all information
  17. potentially available to ensure the protection of human health and the environment.
  19. We hope that the Commission will look to adopt workable, proportionate and science based
  20. criteria which ensure that regulators have the necessary tools to make informed decisions;
  21. maintaining the existing high levels of protection for human health and the environment,
  22. while also ensuring that European farmers have access to essential crop protection products.
  23. Further information in the Zip file annex – ECPA letter ahead of Nov 18th SCoPAFF/ED
  24. meeting -
  26. Bee guidance document (Agenda items A.16)
  28. ECPA is supportive of a revision of the pollinator risk assessment. However, we still fail to
  29. see how the outdated document from 2013 will ensure appropriate risk assessment for
  30. pollinators and allow risk managers to take robust decisions.
  32. We continue to be of the opinion that the current guidance is unworkable and would mean
  33. that all insecticides, and a lot of herbicides, fungicides would fail the first tier laboratory risk
  34. assessment and trigger the need for follow up semi-field and field studies despite the fact
  35. that the study specifications cannot be met. Today, a year after EFSA’s decision to use de
  36. facto this unapproved document, we see the practical consequences with nearly all EFSA
  37. conclusions highlighting risks and data gaps1. This clearly demonstrates the inappropriate
  38. calibration of the guidance, with the protection goals sustaining the whole document being
  39. based on incorrect and extremely conservative assumptions. It also creates unnecessary
  40. complexity for many substances that can only be addressed at Member State level.
  42. ECPA will continue to ask that the Commission, EFSA and Member States:
  44.  Not to adopt the guidance document as it currently stands, on the basis that it is
  45. not fit for purpose.
  46.  Reject the proposed legislative changes when the proposed trigger values remain
  47. questionable and are not based on the most recent scientific knowledge
  48.  Carry out a transparent assessment of the impact of the proposed measures
  49. before taking a final decision
  50.  Review the progress gained in science and knowledge over the last 3 years,
  51. before implementing the measures currently under discussion, which lead to
  52. unfeasible additional data requests.
  53. As industry, we would welcome the opportunity to engage in a technical discussion with risk
  54. assessors and risk managers so that solutions to some practical issues could be jointly
  55. explored.
  57. Co-formulants
  59. ECPA would again highlight industry concerns with the way forward set out in the Discussion
  60. paper on implementation rules for the inclusion of unacceptable co-formulants in Annex III.
  61. We would in particular highlight the impact of duplication of work in the evaluation of coformulants
  62. and the potential impact of the suggested triggers which could potential restrict
  63. many commonly used co-formulants.
  65. Given the potential impact of this exercise, ECPA believes that an impact assessment is
  66. required to ensure a full understanding of the implications. ECPA’s aim is to ensure a
  67. streamlined process that avoids the duplication of effort - in line with the broader principles of
  68. Better Regulation. ECPA will continue to input into the Working Group discussions to support
  69. the development of such a streamlined process.
  71. Further information in the Zip file annex – ECPA letter - Also, please
  72. see separate published paper at
  74. Guidance on the Establishment of the Residue Definition for Dietary Risk Assessment
  76. While we note that the EFSA Guidance Document on the Establishment of the Residue
  77. Definition for Dietary Risk Assessment is not on the agenda for the December meeting,
  78. ECPA would highlight some issues at this stage, ahead of a possible future discussion and
  79. ‘noting’ of the document. We emphasise the complexity of the evaluation scheme, and we
  80. would in particular stress that additional elements (e.g. QSAR tools and databases) are
  81. required for the workable implementation of the guidance document - proceeding without
  82. such tools will lead to additional toxicological testing including unnecessary vertebrate
  83. testing. ECPA has also noted a lack of consistency between the guidance document and the approaches in other national and international systems –impacting global harmonisation of MRLs, import tolerances and trade.
  85. ECPA would therefore propose a technical discussion to ensure a high level of
  86. understanding and consistency (i) across the Member States and, (ii) with international
  87. systems, as well as the provision of a suitable toolkit and respective training requirements, to
  88. support the implementation process.
  90. REFIT evaluation: Regulations 1107/2009 & 396/2005 (Agenda items A.26)
  91. ECPA welcomes the publication of the roadmap for the review of both Regulations. The
  92. review is an essential step to understand the shortcomings of the legislation and to consider
  93. improvement options for the future. ECPA support the roadmap work programme and
  94. believes that an essential element of the review will be to consider improvements options for
  95. - in the implementation of the current legislation and in future legislative changes.
  96. Further information in the Zip file annex – ECPA view on roadmap ( and
  98. ECPA position paper on review ( – July 2015)
  100. Stakeholder dialogue with SCoPAFF
  102. ECPA have recently written to DG SANTE requesting greater Stakeholder transparency and
  103. participation in the work of the ScoPAFF sections on ‘Phytopharmaceuticals’ and ‘Pesticide
  104. Residues’. While all discussions in these groups have to date been held without stakeholder
  105. participation, we request that this policy to reviewed, in particular to ensure greater
  106. consistency with other similar Standing Committees such as the Biocides Committee.
  108. There are two areas where we would request greater transparency:
  110.  Documentation – create a CIRCABC section with stakeholder access for the documents
  111. that are to be discussed in the meeting. While complying with the EU’s transparency
  112. principle, such access to drafts would also enable commenting on latest versions, and
  113. potentially avoid waste of resources in trying to solve subsequent issues.
  114.  Participation - Relevant non-confidential discussions in the SCoPAFF section meetings
  115. should be opened up to stakeholders to allow dialogue with decision makers.
  116. Our experience from other sectors is that the organised participation of stakeholders has
  117. been helpful and have provided a higher level of transparency. We look forward to greater
  118. transparency and greater consistency with the committee procedures in similar policy areas.
  119. Further information in the Zip file annex – ECPA letter to DG SANTE -
  121. To ensure full transparency, this letter is being published on the ECPA website and will be
  122. available at: We would of course welcome a more
  123. detailed discussion with DG SANTE on these issues. If you have any questions about the
  124. ECPA views, please do not hesitate to contact me.
  126. Yours sincerely
  128. Euros Jones
  129. Director, Regulatory Affairs
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