IUCLID demonstration dossiers for pesticides

• Ref: NP/EFSA/FDP/2022/03
• Budget: € 140,000.00
• Approximate launch date: 22/07/2022
• Deadline to register interest: 15/07/2022

Background:

The new regulation on the transparency and sustainability of the EU risk assessment in the food chain, which has been applicable since 27 March 2021, strengthens the Authority’s ability to carry out its risk assessment functions in accordance with the highest transparency standards. This requires applicants to provide plant protection product dossiers to EFSA in IUCLID format . There are four IUCLID working contexts for European Plant Protection Product dossiers:

1. EU_PPP_Basic_Substance
2. EU_PPP_Active Substance
3. EU_PPP_Maximum_Residue_Levels
4. EU_PPP_Microorganisms

Information on the submission requirements for all four types can be found in the Applicants Toolkit under the IUCLID section.

In 2019 EFSA launched a negotiated procedure (NP/EFSA/DATA/TS/2019/01) and a key deliverable under this contract was the creation of two ‘proof of concept’ (PoC) pesticides dossiers in IUCLID format. The resulting dossiers were used to refine the implementation of IUCLID for plant protection dossiers.

The PoC dossiers do not cover all currently available submission types or scenarios and were created in IUCLID version 6.4. There is a need for correctly completed/sanitised dossiers to support the development of training materials, for use in system testing and optimisation and to identify additional improvements that would facilitate dossier completion as well as the need for updates to the existing resources for applicants completing EU_PPP dossiers.

EFSA will provide the contractor with access to the existing PoC pesticide dossiers and to all support and training materials currently developed for the PPP context.

Objectives:

1. To produce fourteen dossiers using the materials provided by EFSA (original POC dossiers, manuals, training materials etc);
2. Analysis of problems encountered and proposals for improvement;

Selection criteria - technical and professional capacity:

• Requirement 1: The tenderer overall must have extensive and demonstrable experience in preparation of regulated product dossiers, pesticide applications, OECD harmonised templates and IUCLID;
• Requirement 2: Ability to provide project team members compliant with these specific expertise requirements:
  • experience in reporting chemical safety studies/data of at least 2 years;
  • experience of software testing or performing quality checks of at least one year;
  • experience in preparation of manuals, SOPs, working instructions, technical documentation or training on the use of IUCLID of at least two years
• Requirement 3: The members of the team must have an excellent level of spoken and written standard UK English. For non-native speakers, this must be demonstrated by an Official certificate of English proving a C1 level OR at least 3 years of working in English;
• Requirement 4: The tenderer must be able to access the cloud IUCLID Database and install IUCLID client or server version for use at their premises and must be able to join remote meetings using Microsoft Teams;

If you are interested in this procedure please send an email within the deadline to efsaprocurement [at] efsa.europa.eu (EFSAprocurement[at]efsa[dot]europa[dot]eu) quoting the reference of the procedure and specifying the following:

• your name/organisation’s name and address;
• whether you participate as a physical person or an organisation/private company.