Microbiological criteria for foodstuffs
Legislation
Rules for testing and sampling
European Commission guidance documents
European Legislation
Commission Regulation (EC) No 2073/2005 (OJ L338, p1, 22/12/2005 ) of 15 November 2005 on microbiological criteria for foodstuffs
Corrected by:
Amended by:
Consolidated version Regulation (EC) No 2073/2005 ( as at 1st December 2011)
National Legislation
For food businesses supervised by the Department of Agriculture, Food and Marine (DAFM), theSea-Fisheries Protection Authority (SPFA) and Local Authorities
European Communities (Food and Feed Hygiene) Regulations 2009 (S.I. No. 432 of 2009)
Amended by:
Relevant Guidance Notes published by the European Commission
Foodstuffs should not contain micro-organisms or their toxins or metabolites in quantities that present an unacceptable risk for human health. The safety of foodstuffs is mainly ensured by a preventive approach, such as implementation of good hygiene practice and application of procedures based on hazard analysis and critical control point (HACCP) principles. Testing against the criteria set down in Regulation (EC) No 2073/2005 should be undertaken when validating or verifying the correct functioning of systems in place. In addition, food business operators (FBOs) should determine shelf-life by a strict testing programme to ensure that the criteria are met over the entire intended shelf-life of the product.
Article 4 of Regulation (EC) No 852/2004 places an obligation on FBOs to comply with microbiological criteria for foodstuffs. This should include testing against the values set for the criteria through the taking of samples, the conduct of analyses and the implementation of corrective actions, in accordance with food law and the instructions given by the competent authority. The producer or manufacturer of a food product has to decide whether the product is ready to be consumed as such, without the need to cook or otherwise process it in order to ensure its safety and compliance with the microbiological criteria. According to Article 3 of Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs, the instructions for use of a foodstuff are compulsory on the labelling when it would be impossible to make appropriate use of the foodstuff in the absence of such instructions. Such instructions should be taken into account by food business operators when deciding appropriate sampling frequencies for the testing against microbiological criteria.
In ensuring compliance with the relevant microbiological criteria set out in Annex I to Regulation (EC) No 2073/2005 , the FBOs at each stage of food production, processing and distribution, including retail, must take measures, as part of their procedures based on HACCP principles together with the implementation of good hygiene practice, to ensure the following:
(a) that the supply, handling and processing of raw materials and foodstuffs under their control are carried out in such a way that the process hygiene criteria are met,
(b) that the food safety criteria applicable throughout the shelf-life of the products can be met under reasonably foreseeable conditions of distribution, storage and use.
Regulation (EC) No 2073/2005 defines ‘food safety criterion’ as meaning 'a criterion defining the acceptability of a product or a batch of foodstuff applicable to products placed on the market' and
‘process hygiene criterion’ as meaning 'a criterion indicating the acceptable functioning of the production process. Such a criterion is not applicable to products placed on the market. It sets an indicative contamination value above which corrective actions are required in order to maintain the hygiene of the process in compliance with food law';
As necessary, the FBOs responsible for the manufacture of a product must conduct studies in accordance with Annex II to Regulation (EC) No 2073/2005 in order to investigate compliance with the criteria throughout the shelf-life. In particular, this applies to ready-to-eat foods that are able to support the growth of Listeria monocytogenes and that may pose a Listeria monocytogenes risk for public health.
Rules for testing and sampling
Regulation (EC) No 2073/2005 sets out specific rules for testing and sampling and requires that the analytical methods and the sampling plans and methods in Annex I to the Regulation are applied as reference methods. The Regulation requires that:
- Samples must be taken from processing areas and equipment used in food production, when such sampling is necessary for ensuring that the criteria are met. In that sampling the ISO standard 18593 shall be used as a reference method. FBOs manufacturing ready-to-eat foods, which may pose a Listeria monocytogenes risk for public health, must sample the processing areas and equipment for Listeria monocytogenes as part of their sampling scheme. FBOs manufacturing dried infant formulae or dried foods for special medical purposes intended for infants below six months which pose an Enterobacter sakazakii risk are required to monitor the processing areas and equipment for Enterobacteriaceae as part of their sampling scheme.
- The number of sample units of the sampling plans set out in Annex I to Regulation (EC) No 2073/2005 may be reduced if the food business operator can demonstrate by historical documentation that he has effective HACCP-based procedures. If the aim of the testing is to specifically assess the acceptability of a certain batch of foodstuffs or a process, the sampling plans set out in Annex I must l be respected as a minimum.
FBOs may use other sampling and testing procedures, if they can demonstrate to the satisfaction of the competent authority that these procedures provide at least equivalent guarantees. Those procedures may include use of alternative sampling sites and use of trend analyses. Testing against alternative micro-organisms and related microbiological limits as well as testing of analytes other than microbiological ones shall be allowed only for process hygiene criteria.
European Commission guidance documents
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
The main objective of this document is to guide food business operators (FBO) producing ready to eat (RTE) foods:
- to demonstrate to the satisfaction of the competent authority that the products will comply with the Community Regulation until the end of the shelf-life,
- to 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 and
- to classify their products into RTE foods in which growth of L.monocytogenes can occur or in RTE foods in which growth of L. monocytogenes will not occur during their shelf-life.
Technical Guidance Document on shelf-life laboratory durability and challenge studies for Listeria monocytogenes in ready-to-eat foods
This document was prepared by the EU Community Reference Laboratory (CRL) for Listeria monocytogenes in collaboration with a working group consisting of 10 laboratories, including 9 National Reference Laboratories (NRL’s) for Listeria monocytogenes. It is a technical guidance document which is basically intended for laboratories conducting shelf-life studies for L. monocytogenes in ready to eat (RTE) foods, in collaboration with Food Business Operators and it provides recommendations on how to select, implement and perform the tests required. It describes the microbiological procedures for determining growth of L. monocytogenes using challenge tests and durability studies in the frame of the application of the Regulation (EC) No. 2073/2005.
European Commission Guidance Note on official controls, under Regulation (EC) No 882/2004, concerning microbiological sampling and testing of foodstuffs
This document provides guidance on official sampling, requirements of official laboratories, analysis methods to be used for official samples and interpretation of microbiological analysis results. The document also explains the link between Regulation (EC) No 882/2004 and Regulation (EC) No 2073/2005 as well as the link between Regulation (EC) No 882/2004 and Regulation (EC) No 178/2002
Information on national microbiological surveillance carried out in Ireland is contained in the Microbiological Surveillance webpage .
Last reviewed: 12/1/2012