Preparatory support for the evaluation of toxicity studies supporting the GM food and feed safety assessment.

The objective of this procurement is for each in vivo toxicity study to perform an evaluation of the overall experimental design and statistical analysis methodology. Background In the context of applications for the authorisation of genetically modified (GM) plants for food and feed uses in the European Union (EU), applicants are required to submit 90-day oral toxicity studies in rodents conducted with whole GM food/feed. In addition, 28-day oral toxicity studies in rodents may be submitted to support the safety assessment of newly expressed proteins or newly produced compounds present in the GM plant. Where scientifically justified, additional toxicity studies may be requested on a case-by-case basis to complement the overall safety assessment of GM food/feed. The EFSA Nutrition and Food Innovation Unit provides scientific and technical support to the GMO Panel in the assessment of in vivo toxicity studies. EFSA aims to outsource part of the activities preliminary to the assessment, such as the verification of the toxicity studies compliance with the applicable requirements, specifications, provisions and methodological standards in the relevant EU regulatory framework and associated guidance documents. Objectives The tasks to be performed by the Contractor shall include the evaluation of the adequacy of the overall experimental design and statistical analysis in relation to the applicable EU regulatory requirements and EFSA guidance. The objective of this procurement is for each in vivo toxicity study to perform an evaluation of the overall experimental design and statistical analysis methodology. The evaluation shall identify deviations from applicable requirements, as well as data gaps, inconsistencies, or uncertainties, and shall formulate questions for the applicant seeking clarification and verify whether all issues have been adequately addressed, identifying any outstanding issues. The estimated number of deliverables is twenty reports per year, based on the average number of studies evaluated by EFSA in recent years in the context of applications received. Professional capacity: overall at organisational level : The Tenderer must demonstrate the technical and professional capacity to perform the contract in accordance with the tender specifications (which will be published on the day of call launch), including extensive and verifiable experience in the scientific evaluation of in vivo regulatory toxicity studies and in statistical analysis methodologies applied to such studies. The Tenderer should also be familiar with the applicable regulatory framework, including relevant OECD test guidelines and with the main guidance documents relevant to the conduct of toxicity studies supporting GM food and feed safety assessments, including those listed below (not exhaustive list): OECD Principles of Good Laboratory Practice (1998) OECD Test Guideline 407 (1998) OECD Test Guideline 408 (1998, 2018, 2025) EFSA Scientific Committee, 2011, Guidance on conducting repeated-dose 90-day oral toxicity studies in rodents on whole food/feed EFSA, 2014, Explanatory statement on the applicability of the EFSA Scientific Committee (2011) guidance for GMO risk assessment EFSA GMO Panel (2011), Guidance for risk assessment of food and feed from genetically modified plants Regulation (EU) No 503/2013 - Annex II, with specific reference to Section 1.4 (Toxicology) Directive 2004/10/EC - with specific reference to the principles of good laboratory practice and the verification of their applications for tests on chemical substances The Tenderer shall ensure adequate resourcing to fully cover the tasks which will be described in the tender specifications to be published The language for the implementation of the assignment shall be English. Team members must demonstrate an adequate level of English proficiency necessary for the execution of the tasks.