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- 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:
- Trade concerns
- 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.
- Transparency
- 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
- legislation.
- 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.
- Yours sincerely
- Euros Jones
- Director Regulatory Affairs
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