Key data
| Regulation | Commission Implementing Regulation (EU) 2026/1305 of 11 June 2026 |
|---|---|
| Amends | Implementing Regulation (EU) 2020/1641 |
| Publication | 12 June 2026 |
| Entry into force | Not specified in the published text |
| Affected parties | Importers, distributors and food operators working with seafood from the USA |
| Category | Agriculture and Fisheries — Food safety |
| Geographic origin | United States of America |
| Affected products | Live, chilled, frozen or processed bivalve mollusks, echinoderms, tunicates and marine gastropods |
Importers and distributors of seafood products of American origin have a new regulatory framework to review. The Implementing Regulation (EU) 2026/1305, published on 12 June 2026, amends Implementing Regulation (EU) 2020/1641 and updates the sanitary and control conditions that bivalve mollusks, echinoderms, tunicates and marine gastropods from the United States must meet to access the European market.
This is not a theoretical rule: the concrete risk for companies is the retention or return of shipments at the border if US suppliers do not adapt to the new requirements. Any operator in the fishing sector, distribution or catering that works with these species of American origin must act now.
What does this regulation establish?
Implementing Regulation (EU) 2026/1305 amends the regulatory framework in force since 2020 for imports of seafood products from the USA. The changes focus on the sanitary and control conditions that these products must demonstrate to cross the European border.
The affected products, in all their commercial presentation forms, are as follows:
| Product | Presentation states covered |
|---|---|
| Bivalve mollusks | Live, chilled, frozen or processed |
| Echinoderms | Live, chilled, frozen or processed |
| Tunicates | Live, chilled, frozen or processed |
| Marine gastropods | Live, chilled, frozen or processed |
The regulation being amended is Implementing Regulation (EU) 2020/1641, which established the previous regime for these imports from the USA. The new regulation updates that framework with revised sanitary and control requirements, although the published text does not publicly detail the exact content of each specific technical change compared to the previous regulation.
The intended use of these products is human consumption, which means that sanitary requirements are of maximum application and any non-compliance activates the EU's border control mechanisms.
Economic and operational impact
The most direct and quantifiable impact for companies is the risk of retention or return of shipments at the border. This means, in practice:
- Storage costs at border facilities while the incident is resolved.
- Total loss of merchandise if it is live or chilled product with an adjusted expiration date.
- Return cost to the US supplier or destruction of the shipment.
- Supply disruption with impact on end customers (restaurants, distributors, food chains).
- Contract review with suppliers to include guarantees of compliance with the new European regulation.
Beyond the immediate economic risk, companies that do not adapt their supplier verification processes assume a reputational risk with their customers and an audit risk from the competent health authorities.
Who does it affect?
- Direct importers of bivalve mollusks, echinoderms, tunicates or marine gastropods from the USA.
- Wholesale distributors of seafood products working with US suppliers.
- Food operators (canning industry, seafood processors) using raw materials of American origin.
- Catering and hospitality companies that import directly or through intermediaries these species from the USA.
- Customs agents and logistics operators managing the clearance of these products at the border.
- Advisors and consultants in foreign trade advising companies in the fishing and food sector.
Practical example
A seafood distribution company based in Spain regularly imports live oysters and frozen clams from the USA to supply a restaurant chain and several central market wholesalers.
With the entry into force of Implementing Regulation (EU) 2026/1305, this company must verify that its US supplier complies with the new sanitary and control requirements established. If the supplier has not updated its certifications or cannot demonstrate compliance at the time of customs clearance, the shipment may be retained at the border inspection point.
In the case of live oysters, whose shelf life is very limited, a 48-72 hour retention can result in total loss of merchandise. For frozen clams, the cost of storage in a border cold storage facility and possible return to origin represent a significant economic impact, in addition to supply disruption with end customers.
The solution involves proactively contacting the supplier before the next shipment, requesting updated documentation and reviewing supply contracts to include clauses guaranteeing compliance with European regulatory requirements.
What should companies do now?
- Identify all US suppliers that supply bivalve mollusks, echinoderms, tunicates or marine gastropods, in any format (live, chilled, frozen or processed).
- Contact each supplier to request confirmation that they comply with the new sanitary and control requirements established by Implementing Regulation (EU) 2026/1305.
- Review the sanitary documentation accompanying shipments in transit or pending clearance to detect possible non-compliance before they reach the border.
- Update supply contracts with suppliers to include clauses guaranteeing compliance with current European regulations and transferring responsibility in case of retention.
- Inform the customs agent or logistics operator of the regulatory changes so they apply updated documentary controls in the clearance process.
- Consult the full text of Implementing Regulation (EU) 2026/1305 in the EU Official Journal to verify the specific technical requirements applicable to each product category.
Frequently asked questions
What products from the USA are affected by the new seafood import regulation?
Implementing Regulation (EU) 2026/1305 affects bivalve mollusks, echinoderms, tunicates and marine gastropods from the United States, in their live, chilled, frozen or processed presentations, intended for human consumption.
What happens if my US supplier does not comply with the new requirements?
If the supplier does not demonstrate compliance with the new sanitary and control requirements, the shipment may be retained or returned at the border. This implies direct economic loss (especially in live or chilled product), storage costs and possible supply disruption with your customers.
When does Implementing Regulation (EU) 2026/1305 enter into force?
The exact date of entry into force is not specified in the published information. It is recommended to consult the full text in the EU Official Journal to confirm the applicable date and plan adaptation with sufficient notice.
What regulation does this amend and what changes compared to the previous regime?
The new regulation amends Implementing Regulation (EU) 2020/1641, which was the framework in force for imports of these species from the USA. The amendment updates the required sanitary and control conditions, although the precise technical details of each change must be consulted in the official text published in the EU Official Journal.
Does this regulation also affect restaurants and catering establishments that buy American seafood?
Yes. Operators in the catering and hospitality sector working with bivalve mollusks, echinoderms, tunicates or marine gastropods of US origin must review their supply chains to ensure that the products they receive comply with the new European regulation.
Official source
Consult complete regulation in official source
Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202601305