SCoPAFF_for_6-7_December_2016

Dear Dr Flüh
Dear ScoPAFF members

Ahead of the SCoPAFF-phytopharmaceutical of 6-7 December, ECPA would like to take this
opportunity to provide our input on a number of current issues. Reference is made to the
meeting agenda item where relevant:

Endocrine disruption (Agenda item A.18)

ECPA would underline the concerns we have with the proposal for the criteria for endocrine
disruptors. For decision making under Regulation 1107/2009, we believe regulators should
be provided with the necessary tools to separate out those substances which have the real
potential to cause harm, from those that do not. It remains our firm view that endocrine
disruptors can and should be regulated like other substances of potential concern and be
subject to risk assessment considering both hazard and exposure. A departure from this
framework sets a precedent for regulation that neglects the consideration of all information
potentially available to ensure the protection of human health and the environment.

We hope that the Commission will look to adopt workable, proportionate and science based
criteria which ensure that regulators have the necessary tools to make informed decisions;
maintaining the existing high levels of protection for human health and the environment,
while also ensuring that European farmers have access to essential crop protection products.
Further information in the Zip file annex – ECPA letter ahead of Nov 18th SCoPAFF/ED
meeting - doc.no.27011

Bee guidance document (Agenda items A.16)

ECPA is supportive of a revision of the pollinator risk assessment. However, we still fail to
see how the outdated document from 2013 will ensure appropriate risk assessment for
pollinators and allow risk managers to take robust decisions.

We continue to be of the opinion that the current guidance is unworkable and would mean
that all insecticides, and a lot of herbicides, fungicides would fail the first tier laboratory risk
assessment and trigger the need for follow up semi-field and field studies despite the fact
that the study specifications cannot be met. Today, a year after EFSA’s decision to use de
facto this unapproved document, we see the practical consequences with nearly all EFSA
conclusions highlighting risks and data gaps1. This clearly demonstrates the inappropriate
calibration of the guidance, with the protection goals sustaining the whole document being
based on incorrect and extremely conservative assumptions. It also creates unnecessary
complexity for many substances that can only be addressed at Member State level.

ECPA will continue to ask that the Commission, EFSA and Member States:

 Not to adopt the guidance document as it currently stands, on the basis that it is
not fit for purpose.
 Reject the proposed legislative changes when the proposed trigger values remain
questionable and are not based on the most recent scientific knowledge
 Carry out a transparent assessment of the impact of the proposed measures
before taking a final decision
 Review the progress gained in science and knowledge over the last 3 years,
before implementing the measures currently under discussion, which lead to
unfeasible additional data requests.
As industry, we would welcome the opportunity to engage in a technical discussion with risk
assessors and risk managers so that solutions to some practical issues could be jointly
explored.

Co-formulants

ECPA would again highlight industry concerns with the way forward set out in the Discussion
paper on implementation rules for the inclusion of unacceptable co-formulants in Annex III.
We would in particular highlight the impact of duplication of work in the evaluation of coformulants
and the potential impact of the suggested triggers which could potential restrict
many commonly used co-formulants.

Given the potential impact of this exercise, ECPA believes that an impact assessment is
required to ensure a full understanding of the implications. ECPA’s aim is to ensure a
streamlined process that avoids the duplication of effort - in line with the broader principles of
Better Regulation. ECPA will continue to input into the Working Group discussions to support
the development of such a streamlined process.

Further information in the Zip file annex – ECPA letter - doc.no.26056. Also, please
see separate published paper at https://www.ncbi.nlm.nih.gov/pubmed/27411735

Guidance on the Establishment of the Residue Definition for Dietary Risk Assessment

While we note that the EFSA Guidance Document on the Establishment of the Residue
Definition for Dietary Risk Assessment is not on the agenda for the December meeting,
ECPA would highlight some issues at this stage, ahead of a possible future discussion and
‘noting’ of the document. We emphasise the complexity of the evaluation scheme, and we
would in particular stress that additional elements (e.g. QSAR tools and databases) are
required for the workable implementation of the guidance document - proceeding without
such tools will lead to additional toxicological testing including unnecessary vertebrate
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.

ECPA would therefore propose a technical discussion to ensure a high level of
understanding and consistency (i) across the Member States and, (ii) with international
systems, as well as the provision of a suitable toolkit and respective training requirements, to
support the implementation process.

REFIT evaluation: Regulations 1107/2009 & 396/2005 (Agenda items A.26)
ECPA welcomes the publication of the roadmap for the review of both Regulations. The
review is an essential step to understand the shortcomings of the legislation and to consider
improvement options for the future. ECPA support the roadmap work programme and
believes that an essential element of the review will be to consider improvements options for
- in the implementation of the current legislation and in future legislative changes.
Further information in the Zip file annex – ECPA view on roadmap (doc.no.27064) and

ECPA position paper on review (doc.no.22085 – July 2015)

Stakeholder dialogue with SCoPAFF

ECPA have recently written to DG SANTE requesting greater Stakeholder transparency and
participation in the work of the ScoPAFF sections on ‘Phytopharmaceuticals’ and ‘Pesticide
Residues’. While all discussions in these groups have to date been held without stakeholder
participation, we request that this policy to reviewed, in particular to ensure greater
consistency with other similar Standing Committees such as the Biocides Committee.

There are two areas where we would request greater transparency:

 Documentation – create a CIRCABC section with stakeholder access for the documents
that are to be discussed in the meeting. While complying with the EU’s transparency
principle, such access to drafts would also enable commenting on latest versions, and
potentially avoid waste of resources in trying to solve subsequent issues.
 Participation - Relevant non-confidential discussions in the SCoPAFF section meetings
should be opened up to stakeholders to allow dialogue with decision makers.
Our experience from other sectors is that the organised participation of stakeholders has
been helpful and have provided a higher level of transparency. We look forward to greater
transparency and greater consistency with the committee procedures in similar policy areas.
Further information in the Zip file annex – ECPA letter to DG SANTE - doc.no.26781.

To ensure full transparency, this letter is being published on the ECPA website and will be
available at: http://www.ecpa.eu/transparency-policy. We would of course welcome a more
detailed discussion with DG SANTE on these issues. If you have any questions about the
ECPA views, please do not hesitate to contact me.

Yours sincerely

Euros Jones
Director, Regulatory Affairs