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CropLife Europe (CLE) provides technical support directly related to one of the software components maintained by CropLife Europe. While every effort is made to provide timely technical support no guarantees whatsoever are implied that technical support will be provided or that technical support, when provided, will be accurate.

Please note that our technical support for the software components is limited to issues directly on the components maintained by CropLife Europe. Although we try to maintain the components for a variety of possible environments we cannot provide support to resolve company-specific issues.

Electronic Submission Expert Group

The information and software published on this website is developed and maintained by the electronic Submission Expert Group (eSEG) within CropLife Europe.

What is the eSEG group?

The eSEG (electronic Submission Expert Group) is a group of regulatory, scientific and technical experts within CropLife Europe, that develops and communicates strategies for the efficient and harmonized submission of information from industry to authorities which is needed for the assessment of pesticides (conventional and biopesticides) and GMOs (plant biotechnology).

Why does this group exist?

In light of the amount of information to be submitted by industry and evaluated by regulatory authorities, it is essential to ensure value generation by best use ​of available scientific resources​ instead of generating administrative burden ​for all stakeholders. Well-designed submission and evaluation processes also help fulfil industry commitment to transparency.

In detail, the rationale for this group arises from the following observations:

  • regulations define which information needs to be submitted (data requirements), however how exactly this information should be submitted is normally not regulated in detail.
  • an efficient and transparent handover of information needs to serve the goal of a sound scientific risk assessment and accompany the whole process from 1. the generation and compilation of information in companies’ inhouse environments, via 2. the actual transmission to authorities to 3. the consumption and publication on authority side
  • The transition from document-centric submissions (e.g. with PDF) to structured data-centric submissions (e.g. with XML) affects all systems and stakeholders in this process. The same guiding principles that have proven successful in managing documents should apply to structured information as well.
    Such principles include
    • Reliability and traceability: Single source of information, easy identification and clear links between raw data, summaries and conclusions
    • Life cycle management: Transparency and information about changes of information (who changed what, when and why)
    • Alignment on detailed data requirements, mapping information flows from generation to consumption and, consequently, design of adequate information structures (pick lists, terms, …)  
  • The current process includes significant manual workload for applicants and authorities, i.e., partly unnecessary and time-consuming activities, as scientists and regulatory managers are looking for data / information and several copy / paste operations need to be performed.

What are the main activities?

As a consequence, the group engages in the following activities, either as the driver or in close collaboration with authority stakeholders:

  • Defining and communicating guiding principles for
    • Information exchange and processing
    • Technical platforms and integration
  • Developing, promoting, and sharing best practices
    • Definition of open technical submission standards (CADDY, GHSTS), being the “handover container” of information (see this site). Supply of free-to-use software tools to support the adoption of the submission in those standards (builder, viewer, validator)
    • Execution of technical proof-of-concepts to test a seamless integration of submission software with inhouse systems without disruptions (e.g. with IUCLID and OHTs)
    • Support and guidance of the transition process from document-centric to data-centric submissions (e.g. participation in the EFSA IUCLID technical working group, active participation in the OECD EGEEPD)
      • Definition and modelling of the structured information being handed over, in conjunction with company inhouse regulatory and scientific experts (e.g. in the revision of the OECD OHTs, as part of the IUCLID format definition)
    • Alignment with other regulated domains under the Transparency regulation to ensure a pragmatic and harmonized implementation of the the above-mentioned principles, including the development of industry standards/identification of software for redaction of personal data and confidential business information.

The same goals and guiding principles apply of course also beyond the EU, which is why CropLife Europe member companies also engage within Crop Life International and on OECD level (EGEEPD) to further promote harmonization and best practices.

Members

The full members of the eSEG are:

  • Andrew Whyte, ADAMA (Chair)
  • Michael Lennartz, Syngenta (Co-Chair)
  • Katja Timm, Bayer
  • Viktoria Eriksson, Bayer
  • Marc Teiwes, BASF
  • Stephanie Walburg, BASF
  • Stephane Prioux, FMC
  • Michael Heneghan, Syngenta
  • Sarah Kent, Corteva
  • Rosie Wilson, Corteva
  • Georg Schifferdecker, GCont Consulting

 

CropLife Europe

This website is maintained on behalf of CropLife Europe (CLE). For general question about the information on this website please contact CropLife Europe.

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