Denmark’s control system on live bivalve mollusks is not good enough, according to the European Commission.

DG Sante, the EU’s health and safety unit, held a remote audit in Denmark from April to May 2021.

Auditors said potential public health risks cannot be excluded as the system does not reliably prevent live bivalve mollusks contaminated with E. coli and bivalve mollusks with biotoxins exceeding the regulatory limits from reaching the market.

The check covered the official control of live bivalve mollusks in classified production areas and outside them, until harvesting, including the laboratory support.

Production of live bivalve mollusks in 2018 and 2019 amounted to 90,000 tons. Mainly blue mussel but also common cockle, surf clams, oysters and whelk. There are 165 production areas in national legislation and 56 had activity in the past three years.

A previous audit in 2012 highlighted deficiencies in the classification and monitoring of production areas for microbiological quality and biotoxins, laboratories and testing methods. It made nine recommendations.

Classification and oversight
The latest assessment found national legislation deviates from almost all the EU requirements and made 17 recommendations.

“The classification and monitoring of production areas, and the decisions that the authority takes are inadequate. The absence of oversight over laboratories and the shortcomings in analytical methods, particularly for biotoxins, constitute a serious limitation for the authorities to rely on testing results,” according to the report.

The majority of results considered for classification of production areas are from harvesters’ own-check plans. However, the heat treatment of most samples, a lack of training for samplers, absence of control and supervision and sampling points not representative of the area may impact results.

The Danish Veterinary and Food Administration (DVFA) has a yearly project to verify the reliability of harvesters’ results. The audit evaluated a case with discrepancies between the two, with official results higher than operators’ results. DVFA disregarded findings from official samples and used the harvesters’ lower results for action.

Classification of production areas was not in line with EU requirements. This means there is a risk of live bivalve mollusks with E. coli contamination reaching the market, which is a potential threat to food safety, said the report.

In response, the DVFA said it would reconsider the use of sanitary surveys, including the fixed sampling points and the set-up of monitoring of production areas used for classifications.

The DVFA does not monitor production areas and has not drawn up sampling plans to check the microbiological quality of bivalve mollusks, the presence of toxin-producing plankton in seawater, and biotoxins and heavy metals in bivalve mollusks. This poses a risk that live bivalves with biotoxins and heavy metals above the limits, might be sent for sale.

The DVFA disagreed with the finding about a lack of monitoring of production areas and said it believes the Danish system delivers safe bivalve mollusks to the market. However, the agency recognized that a plan with fixed, sampling points had not been carried out.

Lab findings
The audit team intended to review the laboratory that did all testing for harvesters in 2019 and 2020, but the lab refused a meeting. In 2021, harvesters changed the lab they were using.

The DVFA has access to official or private laboratories, and has a list of labs that harvesters can use for their own-checks. However, it does not carry out any type of control, supervision or verification, so lacks oversight.

One private lab that has a contract with the DVFA is in charge of the analyses for biotoxins of official samples, and of harvesters’ samples. However, it has subcontracted this testing to another lab, in a different country.

Although labs have accredited and validated analytical methods for biotoxins, reliability of results is weakened as validation was more than a decade ago and labs use matrices different from those when the methods were accredited and validated.

The lab for Paralytic shellfish poison cannot analyze part of the compounds of this group and results in proficiency testing show it cannot detect a number of other compounds. This indicates a risk of underestimation of this biotoxin. There were also concerns about the reliability of lipophilic toxin and Amnesic shellfish poison results.

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