Title: Proof of concept pesticides dossier in IUCLID format
Budget: 50,000.00 Euro
Approximate launch date: Mid-August
Deadline to register interest:
08/08/2019 extended to 16/08/2019
Increasing the amount of evidence received as structured data is a key component of EFSA strategic objective 2 “Widen EFSA evidence base and maximise access to its data”. The use of standardised data formats can improve transparency in the risk assessment process, increase efficiency in checking dossier ‘admissibility’ and confidentiality claims, enable data mining and support the proactive publication of evidence submitted for risk assessment. Changes to the General Food Law (Regulation (EC) No 178/2002) require the adoption of information management tools which can increase transparency in the processing and assessment of evidence submitted in regulated product dossiers.
EFSA seeks to explore the use of OECD Harmonised Template (OHT) documents in the production and management of regulated product dossiers. OHTs are an international standard for the exchange of a broad range of summaries of chemical safety tests and studies and are already used by the European Chemicals Agency (ECHA). The REACH, CLP and BPR regulations state explicitly that data shall be submitted to European Chemicals agency (ECHA) in IUCLID format.
EFSA has been involved in an analysis with the ECHA to explore whether IUCLID and related technologies could be used to manage regulated product dossier information from the food and feed domain.
As the next step in this collaboration activity EFSA and ECHA plan to run a pilot testing the creation and processing of an active substance pesticides dossier using IUCLID. A key part of this pilot will be the creation of a proof of concept pesticides dossier in IUCLID format.
The following links provide additional background material:
The objectives of the contract resulting from this procurement procedure are as follows:
- Participate in the pesticide dossier pilot project
- Creation of a new active substance proof of concept pesticide dossier
- Creation of a renewal application using the new active substance proof of concept pesticide dossier created in objective 2
Selection criteria - professional capacity:
The proposed expert/experts must have demonstrable experience in the following areas
- Preparation of regulated product dossiers (experience with pesticides dossiers is desirable), OECD harmonised templates or IUCLID
- Reporting chemical safety studies/data
- Software testing / evaluation and performing quality checks
- The project manager must have overall an excellent level of spoken and written standard UK English (proven with C1 certification or 5 years’ experience in working in English)
If you are interested in this procedure, please send an email within the deadline to efsaprocurement [at] efsa.europa.eu quoting the reference of the procedure and specifying the following:
- your name/organisation’s name and address
- whether you would like to participate as a physical person or an organisation/private company.