Microbiological Criteria
Introduction
Foodstuffs should not contain microorganisms, their toxins or metabolites in quantities that present an unacceptable risk for human health. In order to contribute to the protection of public health, Commission Regulation (EC) No 2073/2005 establishes harmonised microbiological criteria for microorganisms, their toxins or metabolites in certain foodstuffs. It also lays down a number of implementing rules. Food business operators at all stages of the food chain, i.e. primary production, processing, manufacturing, distribution, retail and catering must comply with the relevant criteria. For full details of the Regulation and its amendments please consult the legislation section of the FSAI website .
Detailed guidance for food business operators on the implementation of this Regulation is provided in FSAI Guidance Note No. 26. Fact sheets outlining the key elements to be considered by i) primary producers of horticultural products, ii) manufacturers and processors, iii) retailers and iv) caterers are also available (these fact sheets must be read in conjunction with FSAI Guidance Note No. 26).
This section of the website highlights some of the key requirements of the Regulation.
- Types of criteria
- Compliance with criteria
- Testing foodstuffs to assess compliance with the criteria
- Action to be taken in the case of unsatisfactory results
- Shelf-life studies
- Environmental monitoring
Types of criteria
Commission Regulation (EC) No. 2073/2005 as amended, lays down microbiological criteria, i.e. food safety criteria and process hygiene criteria, for various combinations of food commodities and microorganisms, their toxins or metabolites.
- Food safety criteria define the acceptability of a product or batch of foodstuffs. They are applicable throughout the shelf-life of foodstuffs placed on the market.
Food safety criteria are established for microorganisms (usually pathogenic microorganisms), their toxins or metabolites in various food commodities, e.g. Listeria monocytogenes in ready-to-eat foods, staphylococcal enterotoxin in certain cheeses, milk powder and whey powder.
- Process hygiene criteria are used to assess the correct functioning of production processes. They are applicable to foodstuffs either during or at the end of the manufacturing process.
Process hygiene criteria are established for microorganisms (usually indicator microorganisms) in various food commodities, e.g. E. coli in minced meat, Enterobacteriaceae in egg products.
The food safety and process hygiene criteria are laid down in Annex 1, Chapter 1 and Annex 1, Chapter 2 of the Regulation, respectively. See Guidance Note No. 26.
Compliance with the criteria
Food business operators must take measures, as part of their procedures based on GHP and HACCP principles, to ensure compliance with the microbiological criteria. In other words, they must ensure that:
i) The raw materials and foodstuffs under their control are supplied, handled and processed in a manner which ensures compliance with the relevant process hygiene criteria.
ii) The relevant food safety criteria (which are applicable throughout the shelf-life of products placed on the market) can be met under reasonably foreseeable conditions of distribution, storage and use.
Testing foodstuffs to assess compliance with the criteria
The Regulation requires food business operators to test against the criteria, as appropriate, when validating and verifying the correct functioning of their procedures based on GHP and HACCP principles.
There are no specific requirements in Commission Regulation (EC) No. 2073/2005 regarding the laboratory conducting analysis. However, the Food Safety Authority of Ireland (FSAI) strongly recommends that food business operators use the services of accredited laboratories only. Use of an accredited laboratory gives the food business operator confidence in the standard and quality of service provided.
The Regulation, on the other hand, is prescriptive in terms of the analytical method to be used by the laboratory. An analytical method is specified in the Regulation for each microbiological criterion. The laboratory can use the most recent version of this method or, under certain circumstances; the laboratory can use an alternative method (including rapid methods).
It is the responsibility of the food business operator to ensure: i) the laboratory and ii) the analytical method used by the laboratory meet legal and best practice requirements. To assist food business operators, the FSAI has developed a fact sheet entitled ‘Best Practice for Testing Foods when Assessing Compliance with the Microbiological Criteria specified in Commission Regulation (EC) No. 2073/2005’. It includes a questionnaire which should be completed by the laboratory before any analysis is conducted.
In addition, the FSAI has collated lists of alternative rapid methods for food safety criteria and process hygiene criteria. These methods meet the requirements of the Regulation. Please note that methods certified by AFNOR and MicroVal are listed; however, alternative rapid methods certified by other organisations may also meet the requirements of the Regulation.
Action to be taken in the case of unsatisfactory results
Failure to comply with a process hygiene criterion
If a foodstuff fails to comply with a process hygiene criterion, the food business operator must undertake the corrective actions specified in the Regulation for that criterion (i.e. in Chapter 2 of Annex 1 of Commission Regulation (EC) No. 2073/2005). In most cases, these actions are hygiene based, e.g. improvements in production hygiene and selection of raw materials.
In addition to the requirements outlined above, the food business operator must undertake the corrective actions which are defined in their HACCP based-procedures and any other corrective actions necessary to protect the health of consumers. Furthermore, they must take measures to find the cause of the unsatisfactory results in order to prevent the recurrence of the unacceptable microbiological contamination. Those measures may include modifications to the HACCP-based procedures or other food hygiene control measures in place.
Failure to comply with a food safety criterion
If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with a food safety criterion, he/she must immediately implement procedures to remove the unsafe food from the market (where the food has left the immediate control of the initial food business operator).
Unsafe food must be removed from the market through a withdrawal or recall. This must be done in accordance with the requirements of Article 19 of Regulation (EC) No 178/2002. For further details on product recalls and withdrawals please consult FSAI Guidance Note No 10 (Revision 2)
In addition to the requirements outlined above, the food business operator must undertake the corrective actions which are defined in their HACCP based-procedures and any other corrective actions necessary to protect the health of consumers. Furthermore, they must take measures to find the cause of the unsatisfactory results in order to prevent the recurrence of the unacceptable microbiological contamination. Those measures may include modifications to the HACCP-based procedures or other food hygiene control measures in place.
Shelf-life studies
There is an additional requirement for food business operators responsible for the manufacture of a product, to conduct shelf-life studies, as necessary, to investigate compliance with the food safety criteria throughout the shelf-life (i.e. under reasonably foreseeable conditions of distribution, storage and use). In particular, this applies to ready-to-eat foods that are able to support the growth of Listeria monocytogenes and that may pose a L. monocytogenes risk to public health.
The European Commission has produced two guidance documents on shelf-life studies:
i) Guidance Document on Listeria monocytogenes shelf-life studies for ready-to-eat foods under Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs
This document is directed towards food business operators. The aim of this document is to guide food business operators producing ready-to-eat foods, to:
- demonstrate to the satisfaction of the competent authority that the products will comply with the Regulation until the end of the shelf-life
- understand the range of different approaches available to help establish a safe product shelf-life in relation to L. monocytogenes and to decide the appropriate approach for their products
- classify their products into ready-to-eat foods in which growth of L. monocytogenes can occur or into ready-to-eat foods in which growth of L. monocytogenes will not occur during their shelf-life.
http://www.fsai.ie/uploadedFiles/EU_Guidance_listeria_monocytogenes.pdf
ii) Technical Guidance Document on shelf-life laboratory durability and challenge studies for Listeria monocytogenes in ready-to-eat foods
This document is directed towards laboratories conducting shelf life studies. It provides recommendations on how to select, implement and perform the tests required (e.g. challenge test, durability studies, etc.). http://www.fsai.ie/uploadedFiles/EU_Guidance_shelflife_listeria_monocytogenes_en.pdf
In addition, the following FSAI publications should be consulted:
i) FSAI Guidance Note No. 18 ‘Determination of Product Shelf-Life’
ii) The control and management of Listeria monocytogenes contamination in food
Environmental monitoring
Commission Regulation (EC) No. 2073/2005 requires environmental monitoring to be conducted in establishments manufacturing:
- Ready-to-eat foods, which may pose a Listeria monocytogenes risk for public health.
- dried infant formulae or dried foods for special medical purposes intended for infants below six months which pose a Cronobacter spp. (Enterobacter sakazakii) risk
Environmental monitoring should be conducted in other establishments as necessary.
The Regulation requires that samples are taken from processing areas and equipment used in food production. The ISO standard 18593 must be used as a reference method.
For information regarding environmental monitoring for Listeria monocytogenes, please refer to the FSAI report ‘The Control and Management of Listeria monocytogenes Contamination of Food’.
Please note that the EU Reference Laboratory for L. monocytogenes is developing ‘Guidelines on sampling the food processing area and equipment for detection or enumeration of Listeria monocytogenes’.
Last reviewed: 6/2/2012