This Regulation establishes requirements for collecting and analyzing molecular data during food-borne outbreak investigations in the EU. It introduces mandatory Whole Genome Sequencing (WGS) for specific food-borne pathogens and creates a system for sharing this data between Member States through the European Food Safety Authority (EFSA).The Regulation consists of three main articles that outline: (1) the collection and WGS requirements for pathogen isolates, (2) the transmission of WGS results to EFSA, and (3) the implementation timeline. The act introduces new obligations compared to previous legislation by making WGS mandatory for specific pathogens and establishing a standardized data sharing system.Key provisions include:
- Mandatory collection and WGS analysis of five specific pathogens (Salmonella enterica, Listeria monocytogenes, Escherichia coli, Campylobacter jejuni and Campylobacter coli) when associated with outbreaks
- Requirement for food and feed business operators to submit isolates and WGS results to competent authorities upon request
- Detailed requirements for data transmission to EFSA, including specific associated data points like unique reference numbers, sampling dates, and outbreak information
- WGS must be performed in accredited laboratories according to ISO 17025 standards
- The regulation will become applicable from August 23, 2026, allowing time for technical and financial adaptation
