Conclusions of ECPA Residues workshop, 17 & 18 October
Dear Ms Juelicher
Following discussions at a Residues Workshop held on 17th & 18th October, ECPA would like
to take this opportunity to highlight to you a number of important issues related to the
implementation of Regulation 396/2005.
The workshop was organised to look at the implementation challenges linked to the
regulation and we welcomed the active participation of DG SANTE and EFSA officials at the
meeting. It was also attended by a broad range of stakeholders including participants from
the crop protection industry, EU national authorities, third country Missions to the EU as well
as farmers and food chain representatives from the EU and third countries.
The following key points came from the workshop discussions:
While the implementation of Regulation 396/2005 has led to significant improvements in
ensuring harmonised EU MRLs, a number of sectors highlighted during the workshop that
this issue is their biggest policy challenge at present, and is having a significant impact on
predictability and on trade.
With regular MRL changes in the EU system, one significant challenge relates to shelf life of
food products. Numerous examples were given where crops have been treated prior to
legislative changes in the MRLs – and where these products can not comply with the
amended EU MRL. This is an area that requires further consideration, to ensure that sensible
MRL transitional periods are built into the process, in particular for raw and processed
products that have a multi-year shelf life e.g. frozen or tinned foods.
Many stakeholders also requested greater transparency in the process of MRL reviews and
early notice of subsequent outcomes. While the process may be very clear to those working
within the system in the relevant authorities, the process remains very unclear for the
regulated sectors. Additional steps need to be put in place to provide greater transparency in
the MRL review process, in order to ensure that stakeholders are informed and can provide
input where required. Providing transparency similar to that seen in other regulated sectors
(e.g. biocides, REACH) requires further consideration and ECPA will provide further food
chain suggestions on how this could be developed.
Developments in the evaluation of MRLs
A number of guidance documents are currently under development that could have a
significant impact on the MRL setting and review processes in the EU and concerns were
raised about the potential increase in complexity and the resources required to deal with
these changes. The workshop noted in particular the possible revision of the JMPR guidance
on the IESTI equation, and the EU discussions on Cumulative Risk Assessment (CRA) and
Residue Definition for Dietary Risk Assessment.
For the guidance document on residue definition, it was highlighted that the adoption of the
current guidance would have a significant impact, requiring additional data generation,
greater resources in industry and authorities. It would also reduce the number of crop MRLs,
and introduce a disconnect in the residue definitions between that in the EU and third
countries. The unnecessary envisaged increase in animal testing was also highlighted;
further refinements are therefore essential to ensure workable application of the residue
definition guidance that minimises vertebrate testing in line with the EU’s animal welfare
The discussions on IESTI & CRA are on-going and it is hoped that progress can be made to
ensure final guidance that is workable and realistic.
Improving the EU legislative framework
With the planned review of Regulation 396/2005 and Regulation 1107/2009, which we
understand will take place in 2017, a number of suggestions were discussed for future
legislative improvements. Many of the workshop participants will actively contribute to this
important legislative review and will highlight blockers in the current legislation and suggest
improvements for the future.
While we believe that legislative improvements are required, we understand that this is a
long term process; we will therefore work with policy makers to share and promote
procedural improvements in the application of the current legislation. One key example is the
faster setting of MRL to encourage innovation for new crops and uses into the EU market.
The workshop also discussed market issues such as private standards, brand management
and the importance of training to ensure the highest level of compliance. All workshop
presentations are available on the ECPA website
We would of course welcome the opportunity to discuss these conclusions with you in due course.
Director Regulatory Affairs