The classification of a production area determines the treatment required before Live Bivalve Molluscs (shellfish) may be marketed for human consumption.
Shellfish production and relay areas are classified according to the levels of E. coli detected in shellfish flesh.
Permitted levels of E. coli
Levels of E. coli are measured per 100g flesh.
In all cases, the health standards are set out in:
- Annex III of retained EU law Regulation (EC) 853/2004
- Articles 53, 54 and 55 of retained EU law Regulation (EU) 2019/627
The end product microbiological criteria specified in the retained EU law Regulation (EC) 2073/2005 must also be met.
The production area will be classified as A, B or C, with A as the least and C as the most contaminated. The level of treatment required to remove contamination from the LBMs after harvesting depends on this classification. If contamination levels are consistently so high that a class C cannot be achieved then harvesting from the area may be prohibited.
The standards that must be achieved and the level of treatment required for each classification are:
- minimum of 10 samples required per year
- 80% of sample results must be less than or equal to 230 E. coli/100g
- no results may exceed 700 E. coli/100g
Shellfish can be harvested for direct human consumption if the end product standard requirements are met.
- minimum of 8 samples required per year
- 90% of sample results must be less than or equal to 4600 E. coli/100g
- No sample result may exceed 46000 E. coli/100g
Shellfish can be supplied for human consumption after one of three processes. The options are:
- purification in an approved establishment
- relaying for at least one month in a classified Class A relaying area
- an EC approved heat treatment process
- minimum of 8 samples required per year
- All sample results must be less than or equal to 46000 E. coli/100g
Shellfish can only be sold for human consumption after completing one of three possible processes.
These processes are:
- relaying for at least two months in an approved class B relaying area followed by treatment in an approved purification centre
- relaying for at least two months in an approved class A relaying area
- after an EC approved heat treatment process
Shellfish from areas with consistently prohibited level results (greater than 46000 E. coli/100g) must not be subject to production or be harvested.
Shellfish can be purified (depurated) by holding them in purpose built tanks of clean or artificial seawater. The shellfish are placed in water for the time necessary to reduce contamination to make them fit for human consumption. The water conditions encourage the shellfish to filter out contaminants such as E. coli.
Dispatch centres are any on-shore or off-shore area that processes shellfish fit for human consumption.
All purification and dispatch establishments must be approved by your local authority. You must meet the specific requirements for purification and dispatch centres in Annex III of retained EU law Regulation (EC) 853/2004.
EU references in FSA guidance documents
The FSA is updating all EU references, to accurately reflect the law now in force, in all new or amended guidance published since the Transition Period ended at the end of 2020. In some circumstance it may not always be practicable for us to have all EU references updated at the point we publish new or amended guidance.
Other than in Northern Ireland, any references to EU Regulations in this guidance should be read as meaning retained EU law. You can access retained EU law via HM Government EU Exit Web Archive. This should be read alongside any EU Exit legislation that was made to ensure retained EU law operates correctly in a UK context. EU Exit legislation is on legislation.gov.uk. In Northern Ireland, EU law will continue to apply in respect to the majority of food and feed hygiene and safety law, as listed in the Northern Ireland Protocol, and retained EU law will not apply to Northern Ireland in these circumstances.
Potential classification and filling out the form
If you are interested in principle to harvest/fish or relay shellfish in England, Wales and Northern Ireland, you must first apply for classification of the production area. The production or relay area application form should be completed by the applicant (the harvester) in conjunction with the local authority.
Please complete and submit this form electronically, along with a suitable map and any other relevant supporting information, and refrain from completing by hand. Hard or scanned copies will not be accepted.
Please note that the classification of a shellfish harvesting area does not confer the right to harvest shellfish.
You may need permissions from other bodies before proceeding. It is the responsibility of the applicant to obtain these permissions, as required, and for the local authority to check everything is in place, including their ability to sample for ongoing monitoring, before the application is submitted to the FSA.
After you’ve sent the form
Once we receive your application, it is verified by us and we will ask for further information or clarification if needed. Once we are satisfied, we will send it to our contractor to undertake a sanitary survey if it’s necessary.
A sanitary survey is an assessment of the pollution sources affecting the shellfish harvesting area, to determine appropriate sampling points and a sampling plan for potential classification.
Ten official control samples, taken by the local authority in England and Wales and a range of sampling bodies in Northern Ireland, at least a week apart are required for a provisional classification. After a full year of official control sampling, an annual classification may be granted.
A minimum of 16 weeks from the date of application submission is required before any shellfish harvesting could commence, pending approval of classification.
Further information on the classification process is available in the classification protocol.
Sanitary survey reports
Between April 2017 and March 2020 an interim arrangement was in place for the assessment of new production areas to determine provisional representative monitoring points (RMPs). An RMP is one monitoring point within a shellfish production area, which can represent a number of sites within that production area.
From April 2020, we commission sanitary surveys which consider additional information for production areas.
You can apply for potential classification in England and Wales using our application form.
You can apply for classification in Northern Ireland using our application form.
Dealing with high results
A local action group is led by your local authority and can include local industry groups, fishermen or shellfish gatherers and other stakeholders who can contribute to the investigation, e.g. the Environment Agency or Natural Resources Wales and Water Companies.
This group deal with high results and consider whether to:
- close the bed
- notify harvesters
- take action to protect public health
- liaise with FSA food incidents when necessary
For further information please refer to our Local action group guidance.
Local action plans are decided using local factors and conditions. The amount of detail in the plan will depend on:
- the number and size of shellfish beds under the responsibility of the local food authority
- any special local conditions
- the number of stakeholders involved
Action states apply to all classes of shellfish beds. It will be in place after your results have been found to be above the permitted level.
A bed may be temporarily downgraded or closed as part of short term control measures during an action state.
To re-open the bed at its previous classification, two consecutive satisfactory samples taken at least seven days apart.