2.4 National and European regulations, directives, and legal procedures relating to bivalve mollusc aquaculture: EU regulations, food safety directives, classification of aquaculture production areas

2.4.3 Regulations for the export of juvenile bivalve molluscs used for reintroduction into the marine environment in other EU countries: risk of introducing alien species or diseases

The transboundary movement of juvenile bivalve molluscs intended for reintroduction or restocking in marine environments of other European Union Member States is regulated by Regulation (EU) 2017/625 on official controls and Regulation (EU) 2016/429, known as the Animal Health Law, which governs the prevention and control of transmissible animal diseases. These instruments are complemented by Regulation (EC) No. 708/2007, which regulates the use of non-native and locally absent species in aquaculture at the European level. Bivalve molluscs, as filter-feeders, are particularly susceptible to the accumulation and transmission of pathogens, including bacteria, viruses, and parasites, acting as vectors for associated alien species. The translocation and reintroduction of juvenile stocks represents one of the main routes of unintentional introduction of non-native organisms into European marine systems. This risk is also widely recognized in the guidelines developed by the International Council for the Exploration of the Sea (ICES), which emphasize the need to adopt preventive assessment procedures, quarantine measures, and monitoring systems to limit the ecological impacts of translocations. This likelihood is further amplified by the difficulty of ensuring complete traceability of intra-Community operations and the variability in the application of control measures between Member States. European legislation explicitly recognizes the health risks associated with the spread of bivalve molluscs diseases, listing diseases such as bonamiosis caused by the protozoan Bonamia ostreae, which affects flat oysters (Ostrea edulis), marteiliosis caused by a protozoan called Marteilia refringens, which affects flat oysters and mussels (Mytilus spp.), and other infections that pose a significant threat to wild populations and aquaculture stocks.

To mitigate these risks, the European regulatory system provides for the classification of production areas and specific health requirements for the movement of live molluscs, precisely to limit the cross-border spread of these pathogens. Regulation (EU) 2017/625 strengthens the role of official controls along the supply chain, assigning the responsibility of verifying the health and environmental compliance of movements to the competent authorities of the Member States. In this context, European-level supervision, exercised through audits and verification systems, helps ensure a certain degree of harmonization, while not completely eliminating operational differences between different national systems.

From an ecological risk perspective, the movement of juvenile bivalves not only involves the transfer of the target species but can also include a series of unintentional associated organisms, increasing the risk of introducing alien species into new environments. This aspect is particularly relevant in reintroduction and restocking programs, where the objective of ecological restoration can be compromised by unforeseen side effects related to insufficient health control measures. 

Furthermore, critical issues related to traceability and regulatory practices persist among Member States, resulting in significant regulatory inconsistencies across countries. The European Union includes molluscs among the substances requiring mandatory controls and declarations, but this is not implemented or only partially implemented in other countries. In this context, characterized by health and environmental risks associated with the movement of bivalve molluscs, the need to ensure effective traceability has led to the adoption of shared digital tools at the European level, such as the TRACES (Trade Control and Expert System) system. This is the European Union's official IT infrastructure for recording the movements of live bivalve molluscs within and outside the EU. 

Its primary function is to ensure complete traceability of batches throughout the supply chain, allowing authorities to monitor the origin, destination, and health status of mussels. The use of TRACES for intra-Community trade in live bivalve molluscs is mandatory under the regulatory framework defined by Regulation (EU) 2017/625 on official controls and Regulation (EU) 2016/429. However, in some specific situations, such as bivalve molluscs intended exclusively for relaying, TRACES notification requirements may not be mandatory. The IT platform allows for the digitization of health certificates and their electronic validation. Operators are required to notify the competent authorities of shipments in advance, generally 24 to 48 hours before departure, to allow for official controls. 

The use of TRACES contributes to transparency and security in trade, ensuring document traceability throughout the supply chain. Countries such as Italy, Greece, France, Ireland, and Spain use the same TRACES system and operate within a harmonized regulatory framework. This ensures a high level of structural and procedural uniformity among the countries considered, without any substantial regulatory or functional differences. The only difference would be the data quality, which depends on the national systems.