In the interests of food safety and public health, it lays down the microbiological criteria* for certain micro-organisms* and the rules which food businesses must follow with respect to the general and specific hygiene requirements laid down in Regulation (EC) No 852/2004 on the hygiene of foodstuffs.
The purpose is to provide objectives and reference points to assist food businesses and EU countries’ competent authorities to manage and monitor the safety of food.
The regulation requires food businesses to ensure that the food they handle, supply or process complies with these criteria.

KEY POINTS

Microbiological criteria

The regulation sets out 2 types of microbiological criteria with which food businesses must comply, listed in its Annex I:

food safety criteria;
process hygiene criteria.

Food businesses at each stage of food production, processing and distribution, including retail, must, as part of their procedures based on HACCP principles* and using good hygiene practice, ensure 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;
the food safety criteria applicable throughout the shelf-life of the products can be met under reasonably foreseeable conditions of distribution, storage and use.

For each food category, the regulation and its annex specify:

the micro-organisms for which it must be tested;
the sampling plan (the number of units to be tested, frequency, etc.);
the limits for each sample unit tested;
the analytical reference method to be used;
the stage at which the criterion applies (e.g. end of the manufacturing process, at the time in the manufacturing process when the count of a given micro-organism is expected to be highest);
the action in case of unsatisfactory results.

Testing and its scope

Food businesses must ensure foods comply with the relevant criteria, and perform appropriate testing for the criteria set out in Annex I. The criteria relate to the following products:

ready-to-eat foods;
fresh poultry meat;
minced meat and meat preparations;
meat products;
mechanically-separated meat;
gelatine and collagen;
dairy products;
egg products;
live bivalve molluscs;
fishery products;
cooked crustaceans and molluscan shellfish;
pre-cut, ready-to eat fruit and vegetables;
sprouts and sprouted seeds;
unpasteurised, ready-to-eat fruit and vegetable juices; and
carcases.

The rules for sampling and for the preparation of test samples are laid down in Annex I.

Results

If test results for either type of criteria are unsatisfactory, food businesses must take the action set out in the regulation. When they observe a trend towards unsatisfactory results, they must take appropriate actions without undue delay to prevent the occurrence of microbiological risks.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 1 January 2006.

BACKGROUND

For more information, see:

Microbiological criteria (European Commission)
European Food Safety Authority (European Food Safety Authority).

KEY TERMS

Microbiological criteria: because foods derived from animals and plants may present a microbiological risk, these criteria give guidance on the acceptability of foodstuffs and their manufacturing processes. The criteria define the acceptability of a product, a batch of foodstuffs or a process, based on the absence, presence or number of micro-organisms, and/or on the quantity of their toxins/metabolites, per unit(s) of mass, volume, area or batch.

Micro-organism: includes bacteria, viruses, yeasts, moulds, algae, parasitic protozoa, microscopic parasitic helminths, and their toxins and metabolites. Common examples include salmonella, listeria and E. coli.

HACCP (Hazard Analysis Critical Control Point) principles: based on 7 internationally agreed principles which identify, evaluate and control hazards relevant to food safety. It focuses on preventing contamination and places a responsibility on food producers to ensure that their product is safe.

MAIN DOCUMENT

Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, pp. 1-26)

Successive amendments to Regulation (EC) No 2073/2005 have been incorporated into the original document. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1-142)

See consolidated version.

Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, pp. 1-54). Text republished in corrigendum (OJ L 226, 25.6.2004, pp. 3-21)

See consolidated version.

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, pp. 1-24)

See consolidated version.

last update 17.05.2019

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