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 https://esubmission.croplifeeurope.eu). 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.
The full members of the eSEG are:
- Katja Timm, Bayer (Chair)
- Andrew Whyte, ADAMA (Co-Chair)
- Marc Teiwes, BASF
- Stephanie Walburg, BASF
- Stefan Tessmann, Bayer
- Gail Schneiders, FMC
- Kristian Franke, FMC
- Michael Lennartz, Syngenta
- Michael Heneghan, Syngenta
- Sarah Kent, Corteva
- Georg Schifferdecker, GCont Consulting
We mourn the death of our chair Dr. Bodo Stadtbäumer (Bayer) who left us in January 2019.