On 24 July 2026, the European Commission adopted a Delegated Regulation amending Annexes II and III to Regulation (EC) No 853/2004, which sets specific hygiene rules for live bivalve molluscs. The changes affect food business operators and competent authorities across all Member States, clarifying identification mark requirements, defining re-immersion, and mandating the use of the TRACES system for registration documents.
The regulation clarifies that live bivalve molluscs from class B or C production areas sent unpurified from approved intermediary operators to purification centres or processing establishments shall not bear an identification mark. This amends Annex II, Section I, Part A, point 3. Additionally, the regulation defines the activity of re-immersion of live bivalve molluscs in Section VII of Annex III to remove ambiguity. The most significant operational change is the requirement for food business operators to use a standardised model available in TRACES for the registration document accompanying live bivalve molluscs after harvesting until the dispatch centre, and to issue the document in TRACES. The Commission has provided a transition period to allow competent authorities and operators sufficient time to comply with this obligation.
The regulation enters into force on the twentieth day after publication in the Official Journal of the European Union. The main impacts are on food business operators, who must adapt their practices to stop applying identification marks to unpurified molluscs from class B or C areas and transition to electronic documentation via TRACES. Competent authorities will need to update their inspection and verification procedures. The changes aim to enhance traceability and food safety while reducing administrative burdens through digitalisation. No prior coverage of this specific file exists in recent months.