Bivalve Molluscs - European Union regulations
General Requirements for Imports
Regulation (EC) No 178/2002: Laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.
Regulation (EC) No 852/2004: Providing general guidance on hygiene of foodstuffs.
Regulation (EC) No 853/2004: Laying down specific hygiene rules of foodstuffs. In the section VII, it provides guidance for:
- General requirements for the placing on the market of live bivalve molluscs;
- Hygiene requirements for the production and harvesting of live bivalve molluscs;
- Structural requirements for dispatch and purification centres;
- Hygiene requirements for purification and dispatch centres; and
- Health standards for live bivalve molluscs.
Regulation (EC) No 854/2004: Laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption. For bivalve molluscs, in Annex II it provides guidance on the classification and monitoring of production and relaying areas.
Regulation (EC) No 882/2004: Provides guidance on official controls performed to ensure the verification of compliance with food law, animal health and animal welfare rules.
Commission regulation (EC) No 136/2004: Laying down procedures for veterinary checks at Community border inspection posts on products imported from third countries.
Council directive 97/78/EC: Laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries.
Council directive 2002/99/EC: Laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption.
Commission regulation (EU) No 28/2012: Laying down requirements for the certification for imports into and transit through the Union of certain composite products and amending Decision 2007/275/EC and Regulation (EC) No 1162/2009.
Commission decision No 2006/766/EC: Establishing the lists of third countries and territories from which imports of bivalve molluscs, echinoderms, tunicates, marine gastropods and fishery products are permitted.
Additives, Contaminants, Antimicrobials and Residues
Commission regulation (EC) No 1881/2006: Provides guidance about contaminants, their standards and their maximum levels.
Regulation (EC) No 1333/2008: Provides guidance about additives in foodstuffs, which are permitted to be added to food sold in the European Union, their standards and their maximum levels.
Commission regulation (EU) No 37/2010: Provides guidance about residues of veterinary drugs, their standards and their maximum levels.
Microbiological and Organic Criteria
Commission regulation (EC) No 2073/2005: Provides guidance about the microbiological maximum limits.
Commission regulation (EU) 2015/2285: Amending Annex II to Regulation (EC) No 854/2004 as regards microbiological requirements for live bivalve molluscs, echinoderms, tunicates and marine gastropods.
Criteria for Biotoxins
Regulation (EC) No 853/2004: Provides guidance in its Section VII about maximum limits of marine biotoxins.
Traceability
Council regulation (EC) No 1005/2008: Establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing.
Council regulation (EC) No 1224/2009: Establishing a Community control system for ensuring compliance with the rules of the common fisheries policy.
Regulation (EU) No 1379/2013: Provides general traceability requirements and guidance related to the imported food inspection advice, the treatment, destruction or re-exportation of non-compliant food.
Labelling and Packaging
Regulation (EC) No 853/2004: In the section VII, it provides guidance on wrapping, packaging, identification marking and labelling of live bivalve molluscs.
How do we find the last consolidated version of the regulations?
The latest version of the updated laws is available at the following link: