Microbiological Criteria for Seafood

Commission Regulation (EC) No 2073/2005 lays down microbiological criteria for foodstuffs within the European Community.

Regulation 2073/2005

Food Business Operators (FBOs) are required to comply with Regulation 2073/2005 by implementing Food Safety Management Systems (based on HACCP principles and Good Hygiene Practice). Microbiological testing should be undertaken as appropriate by FBOs, on a risk-based frequency, to validate and verify of the effectiveness of their food safety management system. Competent authorities such as the SFPA are required to verify FBO compliance with Regulation 2073/2005. In addition to reviewing FBO records, this may involve official control sampling by the SFPA.  

Criteria types

Criteria are divided into Food Safety Criteria and Process Hygiene Criteria.

Food Safety Criteria (FSC) are used to assess the safety of a product or batch of foodstuffs.  FSC usually apply throughout the shelf-life of the food. If a FSC is not met, the FBO will not be able to place the foodstuff on the market. If already on the market, the FBO must inform the SFPA and remove the food from the market (ie initiate a withdrawal / recall). The FBO must take action to find the cause and prevent re-occurrence. It may be possible to use the product for a different purpose, provided that this use doesn’t pose a risk and is authorised by the SFPA. If not yet at the retail stage, SFPA may authorise that the product is submitted for further processing to render it safe.

Process Hygiene Criteria (PHC) are used to assess the correct functioning of production processes. PHC usually apply until the end of the manufacturing process. Failure to meet a PHC requires improvements to the process hygiene. The FBO should find the cause and prevent re-occurrence.

Microbiological criteria of relevance to seafood

Regulation 2073/2005 includes microbiological criteria of relevance to seafood as outlined in the table below.

Table 1. Microbiological Criteria in Regulation 2073/2005 of Relevance to Fishery Products and Other Seafood

Food Descriptor (NB: More than one may apply to a given food) Food Safety Criteria Process Hygiene Criteria
  Listeria monocytogenes Salmonella E. coli Histamine E. coli Coagulase-positive Staphylococci
Ready-to-eat (RTE) foods (e.g. smoked salmon, cooked crab meat)¥ · √ (Ref. nos. 1.1, 1.2 & 1.3ª)          
Cooked crustaceans & molluscan shellfish   √ (Ref. no. 1.16)        
Live bivalve molluscs and live echinoderms, tunicates and gastropods*   √ (Ref. no. 1.17) √ (Ref. no. 1.25 )      
Fishery products from fish species associated with a high amount of histidine§       √ (Ref. no. 1.26)    
Fishery products which have undergone enzyme maturation in brine, manufactured from fish species associated with high amounts of histidine       √ (Ref. no. 1.27)    
Shelled & shucked products of cooked crustaceans & molluscan shellfish         √ (Ref. no. 2.4.1) √ (Ref. no. 2.4.1)


¥RTE food: food intended for direct human consumption without the need for cooking or other processing effective to reduce to an acceptable level or eliminate micro-organisms of concern.

·Regular testing against the L. monocytogenes criterion is not required under normal circumstances for: (a) RTE live bivalve molluscs  and (b) RTE foods that have undergone a treatment to eliminate L. monocytogenes when recontamination is not possible after this treatment (eg for products heated in their final package).

*Bivalve Molluscs: mussels, oysters, scallops, clams, etc.; Echinoderms: urchins, sea cucumbers, etc.; Tunicates: sea squirts; Gastropods: whelks, winkles, etc.

§Fish associated with high histidine levels: tuna, mackerel, pilchards, sardines, anchovies, herring etc.

ªFor reference purposes, criteria are given a Food Category Reference Number in Regulation 2073/2005.

This table is provided only for guidance. For information on sampling plans, analytical methods, limits and interpretation of results, please refer to Regulation 2073/2005 as amended (see links below). 

Further information

To view Commission Regulation (EC) No 2073/2005, associated legislation and European Commission Guidance Documents, please refer to the microbiological criteria for foodstuffs page in the legislation section of the Food Safety Authority of Ireland (FSAI) website.

To view relevant FSAI publications (including FSAI Guidance Note No. 26 – Guidance for Food Business Operators on the implementation of Commission Regulation (EC) No 2073/2005 on the Microbiological Criteria for Foodstuffs), please refer to the microbiological criteria page in the Food Businesses HACCP section of FSAI website.