In the complex world of food safety, regulations play a pivotal role in safeguarding consumer health.

Among these regulations, Commission Regulation (EC) No 2073/2005 defines the acceptable levels of microorganisms in food products and was meticulously designed to mitigate the risk of foodborne illnesses by controlling the presence of pathogens.

In this article, Ester Benguerel, Food Safety and Animal Welfare Technical Lead at E&J, explains how microbiological regulations can help food businesses manage microbial risks and provide safe food to consumers.


Understanding microbiological criteria

The microbiological criteria, as outlined in Regulation 2073/2005, is categorised into two main types:

Food safety criteria: these define the microbiological acceptability of food placed on the market during shelf-life and are used to assess the safety of a product or batch of foodstuffs. They focus on pathogens, their toxins or metabolites that pose a significant risk to human health from food placed on the market. They specify maximum limits for the presence of pathogens such as Salmonella, Listeria monocytogenes, and Escherichia Coli in food products, ensuring that they do not reach levels that could cause illness.

Process hygiene criteria: this is used to assess the hygienic functioning of production processes at the end of the manufacturing process. Unlike food safety criteria, process hygiene criteria target indicator organisms, such as total viable count (TVC), Enterobacteriaceae and Salmonella, which serve as indicators of overall hygiene and process control during food production. These criteria help assess the effectiveness of hygiene practices and the adequacy of process controls in food establishments.

To achieve compliance with microbiological criteria, food business operators are required to establish robust Food Safety Management Systems aligned with the microbiological criteria. This entails devising sampling plans, conducting microbiological testing, and implementing corrective actions in the event of a non-compliance.


Interpreting sampling and testing requirements

Regulation 2073/2005 provides detailed guidance on sampling and testing procedures to assess compliance with microbiological criteria. Key aspects to consider include…

Sampling plan: The regulation specifies the sampling plan, including the number of samples to be taken and sampling frequency.

Analytical methods: Approved analytical methods must be employed for microbiological testing to ensure the accuracy and reliability of results. Official laboratories may use alternative analytical methods to the reference method specified in the regulation, provided that the alternative method is validated/certified.

Sampling points: Sampling points within the food production process should be strategically chosen to capture potential microbial hazards at critical control points.

Corrective actions: In case of non-compliance with microbiological criteria, food businesses are required to implement corrective actions.

For food safety criteria, if the results are unsatisfactory, the food business operators must notify the Competent Authority and the product or batch of foodstuffs must be withdrawn or recalled.

For process hygiene criteria, if the results of testing against these criteria are unsatisfactory, the food business operators must take the corrective actions defined in their HACCP based procedures to prevent the reoccurrence of the unacceptable microbiological contamination and other actions necessary to protect consumer health.


Documentation and record-keeping

Regulation 2073/2005 emphasises the importance of maintaining comprehensive records to demonstrate compliance with microbiological criteria. Essential documentation includes…

Sampling records: Records of sampling activities, including sample identification, sampling dates and the rationale for sample selection.

Analytical results: Detailed reports of microbiological test results, including the method used, analytical parameters and interpretation of findings.

Corrective actions: Documentation of any corrective actions taken in response to non-compliant results, along with verification of the effectiveness of these actions in rectifying the situation.


Navigating compliance and enforcement

Compliance with Regulation 2073/2005 is essential for food businesses to ensure the safety and quality of their products and to maintain consumer trust.

Official Veterinarians are tasked to verify food business operators’ compliance with the regulation. This can be done in several ways, including auditing HACCP-based procedures and good hygiene practices, assessing the food business operator’s sampling and testing schemes, checking laboratory test reports, assessing the adequacy of the corrective and preventive actions and taking appropriate enforcement actions when microbiological limits are breached.

By ensuring swift and decisive enforcement, competent authorities play a crucial role in maintaining the integrity of the food supply chain.

Harmonisation of enforcement practices is paramount for fostering consistency and coherence in the application of microbiological standards across all food businesses.


Final thoughts

Commission Regulation 2073/2005 serves as a framework for controlling microbiological hazards in foodstuff and safeguarding public health.

By understanding and adhering to its provisions regarding microbiological criteria, sampling and testing requirements, food businesses can effectively manage microbial risks throughout the food supply chain. Compliance with these standards not only ensures regulatory compliance but also reinforces the commitment to providing safe and wholesome food products to consumers.


For more information on our Official Controls, head to our Services page.