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The regulatory framework for bivalve mollusc aquaculture in the European Union is characterized by a high degree of articulation and integration between food law, environmental legislation, and health control systems. At the European level, the discipline is based on a coordinated set of regulations that define the general principles of food safety, the hygiene and health conditions of production, and official control mechanisms throughout the supply chain. The safety of mussel farmed products depends significantly on the environmental conditions of the production areas and the quality of monitoring systems (EFSA, 2015; FAO, 2023). In particular, at the European level, the legal framework is based on Regulation (EC) No. 178/2002, which establishes the general principles of food law in the European Union, introducing the concept of primary responsibility of the food business operator and the risk-based approach. This is the basis for Regulations (EC) No. 178/2002 and (EC) No. 178/2002. Regulation (EC) No. 852/2004, which defines general food hygiene requirements and mandates the application of procedures based on the HACCP principles, and Regulation No. 853/2004, which establishes specific requirements for foods of animal origin, devoting a specific section to live bivalve molluscs and the hygiene and health conditions for their placing on the market. A central role in the governance system is played by Regulation (EU) 2017/625 on official controls along the agri-food chain, which strengthened and harmonized inspection and verification procedures by competent authorities in the Member States. This regulation, together with Implementing Regulation (EU) 2019/627, defines the operational procedures for monitoring bivalve mollusc production areas, including sampling methods, classification criteria, and continuous health surveillance. A key element of the European regulatory system is the classification of production areas, which is the main risk management tool for bivalve molluscs. This classification is based on monitoring fecal contamination, measured by the concentration of Escherichia coli in mollusc tissue, used as a reference microbiological indicator. Based on the levels detected, areas are divided into three health classes: A, B, and C, each of which determines the marketing conditions and required post-harvest treatments.

Class A areas have the lowest levels of contamination and allow the direct marketing of molluscs for human consumption, provided they meet the required health standards.

Class B areas have intermediate levels of contamination and require molluscs to undergo purification or relaying before marketing, while Class C areas, characterized by higher levels, allow harvesting only after extended relaying periods or equivalent treatments.

The threshold values are defined quantitatively: for example, for class A, at least 80% of samples must have concentrations less than or equal to 230 E. coli per 100 grams of tissue, while for class B the limit rises to 4,600 E. coli for 90% of samples, and for class B it reaches 46,000 E. coli per 100 grams of tissue. This system is accompanied by microbiological criteria for the final product, established by Regulation (EC) No. 2073/2005, which also uses E. coli as a benchmark for the food safety of the finished product.

From a procedural standpoint, the classification of areas requires the performance of preliminary health surveys, which include the identification of sources of contamination, the analysis of anthropogenic pressures and seasonal variations, as well as the definition of sampling and continuous monitoring plans.

Competent authorities must also keep updated lists of classified areas to ensure product traceability throughout the supply chain, ensuring that this system is closely linked to the official controls required by European legislation.

At the national level, the regulatory framework is characterized by strong integration between European provisions and internal administrative responsibilities, often spread across multiple levels (national, regional, and local).

Competent authorities are responsible for implementing official controls, classifying areas, and issuing authorizations, in compliance with European requirements but with discretion in organizing monitoring systems and administrative procedures.