Commission Regulation (EC) No 2073/2005
of 15 November 2005
on microbiological criteria for foodstuffs
(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs, and in particular Articles 4(4) and 12 thereof,
OJ L 139, 30.4.2004, p. 1, corrected by OJ L 226, 25.6.2004, p. 3.
Whereas:
(1) A high level of protection of public health is one of the fundamental objectives of food law, as laid down in 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. Microbiological hazards in foodstuffs form a major source of food-borne diseases in humans.
OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).
(2) Foodstuffs should not contain micro-organisms or their toxins or metabolites in quantities that present an unacceptable risk for human health.
(3) Regulation (EC) No 178/2002 lays down general food safety requirements, according to which food must not be placed on the market if it is unsafe. Food business operators have an obligation to withdraw unsafe food from the market. In order to contribute to the protection of public health and to prevent differing interpretations, it is appropriate to establish harmonised safety criteria on the acceptability of food, in particular as regards the presence of certain pathogenic micro-organisms.
(4) Microbiological criteria also give guidance on the acceptability of foodstuffs and their manufacturing, handling and distribution processes. The use of microbiological criteria should form an integral part of the implementation of HACCP-based procedures and other hygiene control measures.
(5) 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. Microbiological criteria can be used in validation and verification of HACCP procedures and other hygiene control measures. It is therefore appropriate to set microbiological criteria defining the acceptability of the processes, and also food safety microbiological criteria setting a limit above which a foodstuff should be considered unacceptably contaminated with the micro-organisms for which the criteria are set.
(6) According to Article 4 of Regulation (EC) No 852/2004, food business operators are to comply with microbiological criteria. 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. It is therefore appropriate to lay down implementing measures concerning the analytical methods, including, where necessary, the measurement uncertainty, the sampling plan, the microbiological limits, the number of analytical units that should comply with these limits. Furthermore, it is appropriate to lay down implementing measures concerning the foodstuff to which the criterion applies, the points of the food chain where the criterion applies, as well as the actions to be taken when the criterion is not met. The measures to be taken by the food business operators in order to ensure compliance with criteria defining the acceptability of a process may include, among other things, controls of raw materials, hygiene, temperature and shelf-life of the product.
(7) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules requires the Member States to ensure that official controls are carried out regularly, on a risk basis and with appropriate frequency. Those controls should take place at appropriate stages of the production, processing and distribution of food to ensure that the criteria laid down in this Regulation are complied with by food business operators.
OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004, p. 1.
(8) The Communication from the Commission on the Community Strategy for setting microbiological criteria for foodstuffs describes the strategy to lay down and revise the criteria in Community legislation, as well as the principles for the development and application of the criteria. This strategy should be applied when microbiological criteria are laid down.
SANCO/1252/2001 Discussion paper on strategy for setting microbiological criteria for foodstuffs in Community legislation, p. 34.
(9) The Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) issued an opinion on 23 September 1999 on the evaluation of microbiological criteria for food products of animal origin for human consumption. It highlighted the relevance of basing microbiological criteria on formal risk assessment and internationally approved principles. The opinion recommends that microbiological criteria should be relevant and effective in relation to consumer health protection. The SCVPH proposed, while awaiting formal risk assessments, certain revised criteria as interim measures.
(10) The SCVPH issued at the same time a separate opinion on Listeria monocytogenes. That opinion recommended that it be an objective to keep the concentration of Listeria monocytogenes in food below 100 cfu/g. The Scientific Committee on Food (SCF) agreed with these recommendations in its opinion of 22 June 2000.
(11) The SCVPH adopted an opinion on Vibrio vulnificus and Vibrioparahaemolyticus on 19 and 20 September 2001. It concluded that currently available scientific data do not support setting specific criteria for pathogenic V. vulnificus and parahaemolyticus in seafood. However, it recommended that codes of practice should be established to ensure that good hygiene practice has been applied.
(12) The SCVPH issued an opinion on Norwalk-like viruses (NLVs, noroviruses) on 30-31 January 2002. In that opinion it concluded that the conventional faecal indicators are unreliable for demonstrating the presence or absence of NLVs and that the reliance on faecal bacterial indicator removal for determining shellfish purification times is unsafe practice. It also recommended using E. coli rather than faecal coliforms to indicate faecal contamination in shellfish harvesting areas, when applying bacterial indicators.
(13) On 27 February 2002 the SCF adopted an opinion on specifications for gelatine in terms of consumer health. It concluded that the microbiological criteria set in Chapter 4 of Annex II to Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC in terms of consumer health were excessive, and considered it sufficient to apply a mandatory microbiological criterion for salmonella only.
OJ L 62, 15.3.1993, p. 49. Directive as last amended by Commission Regulation (EC) No 445/2004 (OJ L 72, 11.3.2004, p. 60).
(14) The SCVPH issued an opinion on verotoxigenic E. coli (VTEC) in foodstuffs on 21 and 22 January 2003. In its opinion it concluded that applying an end-product microbiological standard for VTEC O157 is unlikely to deliver meaningful reductions in the associated risk for the consumers. However, microbiological guidelines aimed at reducing the faecal contamination along the food chain can contribute to a reduction in public health risks, including VTEC. The SCVPH identified the following food categories where VTEC represents a hazard to public health: raw or undercooked beef and possibly meat from other ruminants, minced meat and fermented beef and products thereof, raw milk and raw milk products, fresh produce, in particular sprouted seeds, and unpasteurised fruit and vegetable juices.
(15) On 26 and 27 March 2003 the SCVPH adopted an opinion on staphylococcal enterotoxins in milk products, particularly in cheeses. It recommended revising the criteria for coagulase-positive staphylococci in cheeses, in raw milk intended for processing and in powdered milk. In addition, criteria for staphylococcal enterotoxins should be laid down for cheeses and powdered milk.
(16) The SCVPH adopted an opinion on salmonellae in foodstuffs on 14 and 15 April 2003. According to the opinion, food categories possibly posing a high risk to public health include raw meat and some products intended to be eaten raw, raw and undercooked products of poultry meat, eggs and products containing raw eggs, unpasteurised milk and some products thereof. Sprouted seeds and unpasteurised fruit juices are also of concern. It recommended that the decision on the need for microbiological criteria should be taken on the basis of its ability to protect the consumers and its feasibility.
(17) The Scientific Panel on Biological Hazards (BIOHAZ Panel) of the European Food Safety Authority (EFSA) issued an opinion on the microbiological risks in infant formulae and follow-on formulae on 9 September 2004. It concluded that Salmonella and Enterobacter sakazakii are the micro-organisms of greatest concern in infant formulae, formulae for special medical purposes and follow-on formulae. The presence of these pathogens constitutes a considerable risk if conditions after reconstitution permit multiplication. Enterobacteriaceae, which are more often present, could be used as an indicator for risk. Monitoring and testing of Enterobacteriaceae was recommended in both the manufacturing environment and the finished product by the EFSA. However, besides pathogenic species the family Enterobacteriaceae includes also environmental species, which often appear in the food manufacturing environment without posing any health hazard. Therefore, the family Enterobacteriaceae can be used for routine monitoring, and if they are present testing of specific pathogens can be started.
(18) International guidelines for microbiological criteria in respect of many foodstuffs have not yet been established. However, the Commission has followed the Codex Alimentarius guideline ‘Principles for the establishment and application of microbiological criteria for foods CAC/GL 21 — 1997’ and in addition, the advice of the SCVPH and the SCF in laying down microbiological criteria. Existing Codex specifications in respect of dried milk products, foods for infants and children and the histamine criterion for certain fish and fishery products have been taken account. The adoption of Community criteria should benefit trade by providing harmonised microbiological requirements for foodstuffs and replacing national criteria.
(19) The microbiological criteria set for certain categories of food of animal origin in Directives that were repealed by Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC should be revised and certain new criteria set in the light of the scientific advice.
OJ L 157, 30.4.2004, p. 33, corrected by OJ L 195, 2.6.2004, p. 12.
(20) The microbiological criteria laid down in Commission Decision 93/51 EEC of 15 December 1992 on the microbiological criteria applicable to the production of cooked crustaceans and molluscan shellfish are incorporated in this Regulation. It is therefore appropriate to repeal that Decision. Since Commission Decision 2001/471/EC of 8 June 2001 laying down rules for the regular checks on the general hygiene carried out by the operators in establishments according to Directive 64/433/EEC on health conditions for the production and marketing of fresh meat and Directive 71/118/EEC on health problems affecting the production and placing on the market of fresh poultrymeat is repealed with effect from the 1 January 2006, it is appropriate to incorporate microbiological criteria set for carcases in this Regulation.
OJ L 13, 21.1.1993, p. 11.
OJ L 165, 21.6.2001, p. 48. Decision as amended by Decision 2004/379/EC (OJ L 144, 30.4.2004, p. 1).
(21) 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 of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States 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.
OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15).
(22) Sampling of the production and processing environment can be a useful tool to identify and prevent the presence of pathogenic micro-organisms in foodstuffs.
(23) Food business operators should decide themselves the necessary sampling and testing frequencies as part of their procedures based on HACCP principles and other hygiene control procedures. However, it may be necessary in certain cases to set harmonised sampling frequencies at Community level, particularly in order to ensure the same level of controls to be performed throughout the Community.
(24) Test results are dependent on the analytical method used, and therefore a given reference method should be associated with each microbiological criterion. However, food business operators should have the possibility to use analytical methods other than the reference methods, in particular more rapid methods, as long as the use of these alternative methods provides equivalent results. Moreover, a sampling plan needs to be defined for each criterion in order to ensure harmonised implementation. It is nevertheless necessary to allow the use of other sampling and testing schemes, including the use of alternative indicator organisms, on condition that these schemes provide equivalent guarantees of food safety.
(25) Trends in test results should be analysed, as they are able to reveal unwanted developments in the manufacturing process enabling the food business operator to take corrective actions before the process is out of control.
(26) The microbiological criteria set in this Regulation should be open to review and revised or supplemented, if appropriate, in order to take into account developments in the field of food safety and food microbiology. This includes progress in science, technology and methodology, changes in prevalence and contamination levels, changes in the population of vulnerable consumers, as well as the possible outputs from risk assessments.
(27) In particular, criteria for pathogenic viruses in live bivalve molluscs should be established when the analytical methods are developed sufficiently. There is a need for development of reliable methods for other microbial hazards too, e.g. Vibrio parahaemolyticus.
(28) It has been demonstrated that the implementation of control programmes can markedly contribute to a reduction of the prevalence of salmonella in production animals and products thereof. The purpose of Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents is to ensure that proper and effective measures are taken to control salmonella at relevant stages of the food chain. Criteria for meat and products thereof should take into account the expected improvement in the salmonella situation at the level of primary production.
OJ L 325, 12.12.2003, p. 1.
(29) For certain food safety criteria, it is appropriate to grant the Member States a transitional derogation, enabling them to comply with less stringent criteria but provided that the foodstuffs would only be marketed on the national market. The Member States should notify the Commission and other Member States where this transitional derogation is used.
(30) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:

Article 1 Subject-matter and scope
This Regulation lays down the microbiological criteria for certain micro-organisms and the implementing rules to be complied with by food business operators when implementing the general and specific hygiene measures referred to in Article 4 of Regulation (EC) No 852/2004. The competent authority shall verify compliance with the rules and criteria laid down in this Regulation in accordance with Regulation (EC) No 882/2004, without prejudice to its right to undertake further sampling and analyses for the purpose of detecting and measuring other micro-organisms, their toxins or metabolites, either as a verification of processes, for food suspected of being unsafe, or in the context of a risk analysis.
This Regulation shall apply without prejudice to other specific rules for the control of micro-organisms laid down in Community legislation and in particular the health standards for foodstuffs laid down in Regulation (EC) No 853/2004 of the European Parliament and of the Council, the rules on parasites laid down under Regulation (EC) No 854/2004 of the European Parliament and of the Council and the microbiological criteria laid down under Council Directive 80/777/EEC.
OJ L 139, 30.4.2004, p. 55, corrected by OJ L 226, 25.6.2004, p. 22.
OJ L 139, 30.4.2004, p. 206, corrected by OJ L 226, 25.6.2004, p. 83.
OJ L 229, 30.8.1980, p. 1.

Article 2 Definitions
The following definitions shall apply:
(a) ‘micro-organisms’ means bacteria, viruses, yeasts, moulds, algae, parasitic protozoa, microscopic parasitic helminths, and their toxins and metabolites;
(b) ‘microbiological criterion’ means a criterion defining 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;
(c) ‘food safety criterion’ means a criterion defining the acceptability of a product or a batch of foodstuff applicable to products placed on the market;
(d) ‘process hygiene criterion’ 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;
(e) ‘batch’ means a group or set of identifiable products obtained from a given process under practically identical circumstances and produced in a given place within one defined production period;
(f) ‘shelf-life’ means either the period corresponding to the period preceding the ‘use by’ or the minimum durability date, as defined respectively in Articles 9 and 10 of Directive 2000/13/EC;
(g) ‘ready-to-eat food’ means food intended by the producer or the manufacturer for direct human consumption without the need for cooking or other processing effective to eliminate or reduce to an acceptable level micro-organisms of concern;
(h) ‘food intended for infants’ means food specifically intended for infants, as defined in Commission Directive 91/321/EEC;
OJ L 175, 4.7.1991, p. 35.
(i) ‘food intended for special medical purposes’ means dietary food for special medical purposes, as defined in Commission Directive 1999/21/EC;
OJ L 91, 7.4.1999, p. 29.
(j) ‘sample’ means a set composed of one or several units or a portion of matter selected by different means in a population or in an important quantity of matter, which is intended to provide information on a given characteristic of the studied population or matter and to provide a basis for a decision concerning the population or matter in question or concerning the process which has produced it;
(k) ‘representative sample’ means a sample in which the characteristics of the batch from which it is drawn are maintained. This is in particular the case of a simple random sample where each of the items or increments of the batch has been given the same probability of entering the sample;
(l) ‘compliance with microbiological criteria’ means obtaining satisfactory or acceptable results set in Annex I when testing against the values set for the criteria through the taking of samples, the conduct of analyses and the implementation of corrective action, in accordance with food law and the instructions given by the competent authority;
Substituted by Commission Regulation (EU) No 209/2013 of 11 March 2013 amending Regulation (EC) No 2073/2005 as regards microbiological criteria for sprouts and the sampling rules for poultry carcases and fresh poultry meat (Text with EEA relevance).
(m) the definition of ‘sprouts’ in Article 2(a) of Commission Implementing Regulation (EU) No 208/2013 of 11 March 2013 on traceability requirements for sprouts and seeds intended for the production of sprouts;
Inserted by Commission Regulation (EU) No 209/2013 of 11 March 2013 amending Regulation (EC) No 2073/2005 as regards microbiological criteria for sprouts and the sampling rules for poultry carcases and fresh poultry meat (Text with EEA relevance).
See page 16 of this Official Journal.
Substituted by Commission Regulation (EU) 2019/229 of 7 February 2019 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs as regards certain methods, the food safety criterion for Listeria monocytogenes in sprouted seeds, and the process hygiene criterion and food safety criterion for unpasteurised fruit and vegetable juices (ready-to-eat) (Text with EEA relevance).
(n) ‘a broad range of foods’, as referred to in EN ISO 16140-2, means food as defined by the first subparagraph of Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council;
Inserted by Commission Regulation (EU) 2019/229 of 7 February 2019 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs as regards certain methods, the food safety criterion for Listeria monocytogenes in sprouted seeds, and the process hygiene criterion and food safety criterion for unpasteurised fruit and vegetable juices (ready-to-eat) (Text with EEA relevance).
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, p. 1).
(o) ‘independent certification body’ means a body which is independent from the organisation that manufactures or distributes the alternative method and which provides a written assurance, in the form of a certificate, testifying that the validated alternative method meets the requirements of EN ISO 16140-2;
(p) ‘production process assurance of the manufacturer’ means a production process whose management system guarantees that the validated alternative method remains conform to the characteristics required by EN ISO 16140-2 and ensures that mistakes and defects in the alternative method are prevented.

Article 3 General requirements
1 Food business operators shall ensure that foodstuffs comply with the relevant microbiological criteria set out in Annex I. To this end the food business operators at each stage of food production, processing and distribution, including retail, shall 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.
2 As necessary, the food business operators responsible for the manufacture of the product shall conduct studies in accordance with Annex II 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.
Food businesses may collaborate in conducting those studies.
Guidelines for conducting those studies may be included in the guides to good practice referred to in Article 7 of Regulation (EC) No 852/2004.

Article 4 Testing against criteria
1 Food business operators shall perform testing as appropriate against the microbiological criteria set out in Annex I, when they are validating or verifying the correct functioning of their procedures based on HACCP principles and good hygiene practice.
2 Food business operators shall decide the appropriate sampling frequencies, except where Annex I provides for specific sampling frequencies, in which case the sampling frequency shall be at least that provided for in Annex I. Food business operators shall make this decision in the context of their procedures based on HACCP principles and good hygiene practice, taking into account the instructions for use of the foodstuff.
The frequency of sampling may be adapted to the nature and size of the food businesses, provided that the safety of foodstuffs will not be endangered.

Article 5 Specific rules for testing and sampling
1 The analytical methods and the sampling plans and methods in Annex I shall be applied as reference methods.
2 Samples shall 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.
Food business operators manufacturing ready-to-eat foods, which may pose a Listeria monocytogenes risk for public health, shall sample the processing areas and equipment for Listeria monocytogenes as part of their sampling scheme.
Food business operators manufacturing dried infant formulae or dried foods for special medical purposes intended for infants below six months, which pose a Cronobacter spp. risk shall monitor the processing areas and equipment for Enterobacteriaceae as part of their sampling scheme.
3 The number of sample units of the sampling plans set out in Annex I may be reduced if the food business operator can demonstrate by historical documentation that he has effective HACCP-based procedures.
4 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 shall be respected as a minimum.
5 Food business operators 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.
The use of alternative analytical methods is acceptable provided they are:
validated against the specific reference method provided for in Annex I in accordance with the protocol set out in standard EN ISO 16140-2, and
validated for the food category specified in the relevant microbiological criterion set in Annex I the compliance with which is verified by the food business operator, or validated for a broad range of food as referred to in EN ISO 16140-2.
Proprietary methods may be used as alternative analytical methods, provided they are:
validated, in accordance with the protocol set out in standard EN ISO 16140-2, against the specific reference method provided for verifying compliance with the microbiological criteria laid down in Annex I, as provided for in the third subparagraph, and
certified by an independent certification body.
The certification of the proprietary method referred to in the second indent of the fourth subparagraph shall:
be subject, at least every 5 years, to reassessment through renewal procedures,
show that the production process assurance of the manufacturer was evaluated, and
include a summary of or a reference to the validation results of the proprietary method and a statement on the quality management of the production process of the method.
Food business operators may use other analytical methods than those validated or certified as provided for in the third, fourth and fifth subparagraphs, where such methods have been validated in accordance with internationally accepted protocols and their use has been authorised by the competent authority.

Article 6 Labelling requirements
1 When the requirements for Salmonella in minced meat, meat preparations and meat products intended to be eaten cooked of all species set down in Annex I are fulfilled, the batches of those products placed on the market must be clearly labelled by the manufacturer in order to inform the consumer of the need for thorough cooking prior to consumption.
2 As from 1 January 2010 labelling as referred to in paragraph 1 in respect of minced meat, meat preparations and meat products made from poultrymeat will no longer be required.

Article 7 Unsatisfactory results
1 When the results of testing against the criteria set out in Annex I are unsatisfactory, the food business operators shall take the measures laid down in paragraphs 2 to 4 of this Article together with other corrective actions defined in their HACCP-based procedures and other actions necessary to protect the health of consumers.
In addition, they shall 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.
2 When testing against food safety criteria set out in Chapter 1 of Annex I provides unsatisfactory results, the product or batch of foodstuffs shall be withdrawn or recalled in accordance with Article 19 of Regulation (EC) No 178/2002. However, products placed on the market, which are not yet at retail level and which do not fulfil the food safety criteria, may be submitted to further processing by a treatment eliminating the hazard in question. This treatment may only be carried out by food business operators other than those at retail level.
The food business operator may use the batch for purposes other than those for which it was originally intended, provided that this use does not pose a risk for public or animal health and provided that this use has been decided within the procedures based on HACCP principles and good hygiene practice and authorised by the competent authority.
3 A batch of mechanically separated meat (MSM) produced with the techniques referred to in Chapter III, paragraph 3, in Section V of Annex III to Regulation (EC) No 853/2004, with unsatisfactory results in respect of the Salmonella criterion, may be used in the food chain only to manufacture heat-treated meat products in establishments approved in accordance with Regulation (EC) No 853/2004.
4 In the event of unsatisfactory results as regards process hygiene criteria the actions laid down in Annex I, Chapter 2 shall be taken.

Article 8 Transitional derogation
1 A transitional derogation is granted until 31 December 2009 at the latest pursuant to Article 12 of Regulation (EC) No 852/2004 as regards compliance with the value set in Annex I to this Regulation forSalmonella in minced meat, meat preparations and meat products intended to be eaten cooked placed on the national market of a Member State.
2 The Member States using this possibility shall notify the Commission and other Member States thereof. The Member State shall:
(a) guarantee that the appropriate means, including labelling and a special mark, which cannot be confused with the identification mark provided for in Annex II, Section I to Regulation (EC) No 853/2004, are in place to ensure that the derogation applies only to the products concerned when placed on the domestic market, and that products dispatched for intra-Community trade comply with the criteria laid down in Annex I;
(b) provide that the products to which such transitional derogation applies shall be clearly labelled that they must be thoroughly cooked prior to consumption;
(c) undertake that when testing against the Salmonella criterion pursuant to Article 4, and for the result to be acceptable as regards such transitional derogation, no more than one out of five sample units shall be found to be positive.

Article 9 Analyses of trends
Food business operators shall analyse trends in the test results. When they observe a trend towards unsatisfactory results, they shall take appropriate actions without undue delay to remedy the situation in order to prevent the occurrence of microbiological risks.

Article 10 Review
This Regulation shall be reviewed taking into account progress in science, technology and methodology, emerging pathogenic micro-organisms in foodstuffs, and information from risk assessments. In particular, the criteria and conditions concerning the presence of salmonella in carcases of cattle, sheep, goats, horses, pigs and poultry shall be revised in the light of the changes observed in salmonella prevalence.

Article 11 Repeal
Decision 93/51/EEC is repealed.
Article 12 This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1 January 2006.
This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I Microbiological criteria for foodstuffs

Chapter 1. Food safety criteria
Food category	Micro-organisms/their toxins, metabolites	Sampling plan		Limits		Analytical reference method	Stage where the criterion applies
		n	c	m	M		
1.1 Ready-to-eat foods intended for infants and ready-to-eat foods for special medical purposes	Listeria monocytogenes	10	0	Not detected in 25 g		EN/ISO 11290-1	Products placed on the market during their shelf-life
1.2 Ready-to-eat foods able to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes	Listeria monocytogenes	5	0	100 cfu/g		EN/ISO 11290-2	Products placed on the market during their shelf-life
		5	0	Not detected in 25 g		EN/ISO 11290-1	Before the food has left the immediate control of the food business operator, who has produced it
1.3 Ready-to-eat foods unable to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes	Listeria monocytogenes	5	0	100 cfu/g		EN/ISO 11290-2	Products placed on the market during their shelf-life
1.4 Minced meat and meat preparations intended to be eaten raw	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.5 Minced meat and meat preparations made from poultry meat intended to be eaten cooked Substituted by Commission Regulation (EU) No 365/2010 of 28 April 2010 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs as regards Enterobacteriaceae in pasteurised milk and other pasteurised liquid dairy products and Listeria monocytogenes in food grade salt (Text with EEA relevance).	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.6 Minced meat and meat preparations made from other species than poultry intended to be eaten cooked	Salmonella	5	0	Not detected in 10 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.7 Mechanically separated meat (MSM)	Salmonella	5	0	Not detected in 10 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.8 Meat products intended to be eaten raw, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.9 Meat products made from poultry meat intended to be eaten cooked	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.10 Gelatine and collagen	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.11 Cheeses, butter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisation	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.12 Milk powder and whey powder	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.13 Ice cream, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.14 Egg products, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.15 Ready-to-eat foods containing raw egg, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk	Salmonella	5	0	Not detected in 25 g or ml		EN ISO 6579-1	Products placed on the market during their shelf-life
1.16 Cooked crustaceans and molluscan shellfish	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.17 Live bivalve molluscs and live echinoderms, tunicates and gastropods	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.18 Sprouted seeds (ready-to-eat)	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.19 Precut fruit and vegetables (ready-to-eat)	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.20 Unpasteurised fruit and vegetable juices (ready- to-eat)	Salmonella	5	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.21 Cheeses, milk powder and whey powder, as referred to in the coagulase-positive staphylococci criteria in Chapter 2.2 of this Annex	Staphylococcal enterotoxins	5	0	Not detected in 25 g		EN ISO 19020	Products placed on the market during their shelf-life
1.22 Dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age	Salmonella	30	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.23 Dried follow-on formulae	Salmonella	30	0	Not detected in 25 g		EN ISO 6579-1	Products placed on the market during their shelf-life
1.24 Dried infant formulae and dried dietary foods for special medical purposes intended for infants below 6 months of age	Cronobacter spp.(Enterobacter sakazakii)	30	0	Not detected in 10 g		EN ISO 22964	Products placed on the market during their shelf-life
1.25 Live bivalve molluscs and live echinoderms, tunicates and marine gastropods Substituted by Commission Regulation (EU) 2015/2285 of 8 December 2015 amending Annex II to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption as regards certain requirements for live bivalve molluscs, echinoderms, tunicates and marine gastropods and Annex I to Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs (Text with EEA relevance).	E. coli	5	1	230 MPN/100 g of flesh and intravalvular liquid	700 MPN/100 g of flesh and intravalvular liquid	EN/ISO 16649-3	Products placed on the market during their shelf-life
1.26 Fishery products from fish species associated with a high amount of histidine	Histamine	9	2	100 mg/kg	200 mg/kg	EN ISO 19343	Products placed on the market during their shelf-life
1.27 Fishery products, except those in food category 1.27a, which have undergone enzyme maturation treatment in brine, manufactured from fish species associated with a high amount of histidine Substituted by Commission Regulation (EU) No 1019/2013 of 23 October 2013 amending Annex I to Regulation (EC) No 2073/2005 as regards histamine in fishery products (Text with EEA relevance).	Histamine	9	2	200 mg/kg	400 mg/kg	EN ISO 19343	Products placed on the market during their shelf-life
1.27a Fish sauce produced by fermentation of fishery products Substituted by Corrigendum to Commission Regulation (EU) No 1019/2013 of 23 October 2013 amending Annex I to Regulation (EC) No 2073/2005 as regards histamines in fishery products (Official Journal of the European Union L 282 of 24 October 2013).	Histamine	1	0	400 mg/kg		EN ISO 19343	Products placed on the market during their shelf-life
1.28 Fresh poultry meat Inserted by Commission Regulation (EU) No 1086/2011 of 27 October 2011 amending Annex II to Regulation (EC) No 2160/2003 of the European Parliament and of the Council and Annex I to Commission Regulation (EC) No 2073/2005 as regards salmonella in fresh poultry meat (Text with EEA relevance).	Salmonella TyphimuriumSalmonella Enteritidis	5	0	Not detected in 25 g		EN ISO 6579-1 (for detection) White- Kauffmann-Le Minor scheme (for serotyping)	Products placed on the market during their shelf-life
1.29 Sprouts	Shiga toxin producing E. coli (STEC) O157, O26, O111, O103, O145 and O104:H4	5	0	Not detected in 25 grams		CEN/ISO TS 13136	Products placed on the market during their shelf-life
n = number of units comprising the sample; c = number of sample units giving values between m and M.							
For points 1.1-1.25, 1.27a and 1.28 m = M.							
The most recent edition of the standard shall be used.							
Regular testing against the criterion is not required in normal circumstances for the following ready-to-eat foods: those which have received heat treatment or other processing effective to eliminate L. monocytogenes, when recontamination is not possible after this treatment (for example, products heat treated in their final package), fresh, uncut and unprocessed vegetables and fruits, excluding sprouted seeds, bread, biscuits and similar products, bottled or packed waters, soft drinks, beer, cider, wine, spirits and similar products, sugar, honey and confectionery, including cocoa and chocolate products, live bivalve molluscs, food grade salt.							
This criterion shall apply if the manufacturer is able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit 100 cfu/g throughout the shelf-life. The operator may fix intermediate limits during the process that must be low enough to guarantee that the limit of 100 cfu/g is not exceeded at the end of shelf-life.							
1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter.							
This criterion shall apply to products before they have left the immediate control of the producing food business operator, when he is not able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit of 100 cfu/g throughout the shelf-life.							
Products with pH ≤ 4,4 or aw ≤ 0,92, products with pH ≤ 5,0 and aw ≤ 0,94, products with a shelf-life of less than five days shall be automatically considered to belong to this category. Other categories of products can also belong to this category, subject to scientific justification.							
This criterion shall apply to mechanically separated meat (MSM) produced with the techniques referred to in paragraph 3 of Chapter III of Section V of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council.							
Excluding products when the manufacturer can demonstrate to the satisfaction of the competent authorities that, due to the ripening time and aw of the product where appropriate, there is no salmonella risk.							
Only ice creams containing milk ingredients.							
							
							
Parallel testing for Enterobacteriaceae and Cronobacter spp. shall be conducted, unless a correlation between these micro-organisms has been established at an individual plant level. If Enterobacteriaceae are detected in any of the product samples tested in such a plant, the batch must be tested for Cronobacter spp. It shall be the responsibility of the manufacturer to demonstrate to the satisfaction of the competent authority whether such a correlation exists between Enterobacteriaceae and Cronobacter spp.							
E. coli is used here as an indicator of faecal contamination.							
Each sample unit comprises a minimum number of individual animals according to EN/ISO 6887-3.							
Particularly fish species of the families: Scombridae, Clupeidae, Engraulidae, Coryfenidae, Pomatomidae, Scombresosidae.							
Single samples may be taken at retail level. In such a case the presumption laid down in Article 14(6) of Regulation (EC) No 178/2002, according to which the whole batch should be deemed unsafe, shall not apply, unless the result is above M.							
							
This criterion shall apply to fresh meat from breeding flocks of Gallus gallus, laying hens, broilers and breeding and fattening flocks of turkeys.							
As regards monophasic Salmonella typhimurium only 1,4,[5],12:i:- is included.							
Taking into account the most recent adaptation by the European Union reference laboratory for Escherichia coli, including Verotoxigenic E. coli (VTEC), for the detection of STEC O104:H4.							
Excluding sprouts that have received a treatment effective to eliminate Salmonella spp. and STEC.							
The term unpasteurised means that the juice has not been subjected to pasteurisation obtained by time-temperature combinations or to other processes validated to achieve an equivalent bactericidal effect to pasteurisation as regards its effect on Salmonella.							

Interpretation of the test results
The limits given refer to each sample unit tested.
The test results demonstrate the microbiological quality of the batch tested.
L. monocytogenes in ready-to-eat foods intended for infants and for special medical purposes:
satisfactory, if all the values observed indicate the absence of the bacterium,
unsatisfactory, if the presence of the bacterium is detected in any of the sample units.
L. monocytogenes in ready-to-eat foods able to support the growth of L. monocytogenes before the food has left the immediate control of the producing food business operator when he is not able to demonstrate that the product will not exceed the limit of 100 cfu/g throughout the shelf-life:
satisfactory, if all the values observed indicate the absence of the bacterium,
unsatisfactory, if the presence of the bacterium is detected in any of the sample units.
L. monocytogenes in other ready-to-eat foods:
satisfactory, if all the values observed are ≤ the limit,
unsatisfactory, if any of the values are > the limit.
E. coli in live bivalve molluscs and live echinoderms, tunicates and marine gastropods:
satisfactory, if all the five values observed are ≤ 230 MPN/100 g of flesh and intravalvular liquid or if one of the five values observed is > 230 MPN/100 g of flesh and intravalvular liquid but ≤ 700 MPN/100 g of flesh and intravalvular liquid,
unsatisfactory, if any of the five values observed are > 700 MPN/100 g of flesh and intravalvular liquid or if at least two of the five values observed are > 230 MPN/100 g of flesh and intravalvular liquid.
satisfactory, if all the values observed are ≤ the limit,
unsatisfactory, if any of the values are > the limit.
Salmonella in different food categories:
satisfactory, if all the values observed indicate the absence of the bacterium,
unsatisfactory, if the presence of the bacterium is detected in any of the sample units.
Staphylococcal enterotoxins in dairy products:
satisfactory, if in all the sample units the enterotoxins are not detected,
unsatisfactory, if the enterotoxins are detected in any of the sample units.
Cronobacter spp. in dried infant formulae and dried dietary foods for special medical purposes intended for infants below 6 months of age:
satisfactory, if all the values observed indicate the absence of the bacterium,
unsatisfactory, if the presence of the bacterium is detected in any of the sample units.
Histamine in fishery products:
Histamine in fishery products from fish species associated with a high amount of histidine except fish sauce produced by fermentation of fishery products:
satisfactory, if the following requirements are fulfilled:
1. the mean value observed is ≤ m
2. a maximum of c/n values observed are between m and M
3. no values observed excess the limit of M.
unsatisfactory, if the mean value observed exceeds m or more than c/n values are between m and M or one or more of the values observed are > M.
Histamine in fish sauce produced by fermentation of fishery products:
satisfactory, if the value observed is ≤ the limit,
unsatisfactory, if the value observed is > the limit.
The test results may be used also for demonstrating the effectiveness of the hazard analysis and critical control point principles or good hygiene procedure of the process.
Deleted by Commission Regulation (EU) 2019/229 of 7 February 2019 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs as regards certain methods, the food safety criterion for Listeria monocytogenes in sprouted seeds, and the process hygiene criterion and food safety criterion for unpasteurised fruit and vegetable juices (ready-to-eat) (Text with EEA relevance).
Deleted by Commission Regulation (EU) No 209/2013 of 11 March 2013 amending Regulation (EC) No 2073/2005 as regards microbiological criteria for sprouts and the sampling rules for poultry carcases and fresh poultry meat (Text with EEA relevance).

Chapter 2. Process hygiene criteria

2.1 Meat and products thereof
Food category	Micro-organisms	Sampling plan		Limits		Analytical reference method	Stage where the criterion applies	Action in case of unsatisfactory results
		n	c	m	M			
2.1.1 Carcases of cattle, sheep, goats and horses	Aerobic colony count			3,5 log cfu/cm2 daily mean log	5,0 log cfu/cm2 daily mean log	EN ISO 4833-1	Carcases after dressing but before chilling	Improvements in slaughter hygiene and review of process controls
	Enterobacteriaceae			1,5 log cfu/cm2 daily mean log	2,5 log cfu/cm2 daily mean log	EN ISO 21528-2	Carcases after dressing but before chilling	Improvements in slaughter hygiene and review of process controls
2.1.2 Carcases of pigs	Aerobic colony count			4,0 log cfu/cm2 daily mean log	5,0 log cfu/cm2 daily mean log	EN ISO 4833-1	Carcases after dressing but before chilling	Improvements in slaughter hygiene and review of process controls
	Enterobacteriaceae			2,0 log cfu/cm2 daily mean log	3,0 log cfu/cm2 daily mean log	EN ISO 21528-2	Carcases after dressing but before chilling	Improvements in slaughter hygiene and review of process controls
2.1.3 Carcases of cattle, sheep, goats and horses	Salmonella	50	2	Not detected in the area tested per carcase		EN ISO 6579-1	Carcases after dressing but before chilling	Improvements in slaughter hygiene, review of process controls and of origin of animals
2.1.4 Carcases of pigs Substituted by Commission Regulation (EU) No 217/2014 of 7 March 2014 amending Regulation (EC) No 2073/2005 as regards Salmonella in pig carcases (Text with EEA relevance).	Salmonella	50	3	Not detected in the area tested per carcase		EN ISO 6579-1	Carcases after dressing but before chilling	Improvements in slaughter hygiene and review of process controls, origin of animals and of the biosecurity measures in the farms of origin
2.1.5 Poultry carcases of broilers and turkeys Substituted by Commission Regulation (EU) No 1086/2011 of 27 October 2011 amending Annex II to Regulation (EC) No 2160/2003 of the European Parliament and of the Council and Annex I to Commission Regulation (EC) No 2073/2005 as regards salmonella in fresh poultry meat (Text with EEA relevance).	Salmonella spp.	50 (5)	7 (6) From 1.1.2012 c = 5 for broilers From 1.1.2013 c = 5 for turkeys	Not detected in 25 g of a pooled sample of neck skin		EN ISO 6579-1	Carcases after chilling	Improvement in slaughter hygiene and review of process controls, origin of animals and biosecurity measures in the farms of origin
2.1.6 Minced meat	Aerobic colony count	5	2	5 × 105 cfu/g	5 × 106 cfu/g	EN ISO 4833-1	End of the manufacturing process	Improvements in production hygiene and improvements in selection and/or origin of raw materials
	E. coli	5	2	50 cfu/g	500 cfu/g	ISO 16649-1 or 2	End of the manufacturing process	Improvements in production hygiene and improvements in selection and/or origin of raw materials
2.1.7 Mechanically separated meat (MSM)	Aerobic colony count	5	2	5 × 105 cfu/g	5 × 106 cfu/g	EN ISO 4833-1	End of the manufacturing process	Improvements in production hygiene and improvements in selection and/or origin of raw materials
	E. coli	5	2	50 cfu/g	500 cfu/g	ISO 16649-1 or 2	End of the manufacturing process	Improvements in production hygiene and improvements in selection and/or origin of raw materials
2.1.8 Meat preparations	E. coli	5	2	500 cfu/g or cm2	5 000 cfu/g or cm2	ISO 16649-1 or 2	End of the manufacturing process	Improvements in production hygiene and improvements in selection and/or origin of raw materials
2.1.9 Carcases of broilers Inserted by Commission Regulation (EU) 2017/1495 of 23 August 2017 amending Regulation (EC) No 2073/2005 as regards Campylobacter in broiler carcases (Text with EEA relevance).	Campylobacter spp.	50	c = 20 From 1.1.2020 c = 15; From 1.1.2025 c = 10	1 000 cfu/g		EN ISO 10272-2	Carcases after chilling	Improvements in slaughter hygiene, review of process controls, of animals' origin and of the biosecurity measures in the farms of origin
n = number of units comprising the sample; c = number of sample units giving values between m and M.								
For points 2.1.3-2.1.5 and 2.1.9 m = M.								
The most recent edition of the standard shall be used.								
The limits (m and M) shall apply only to samples taken by the destructive method. The daily mean log shall be calculated by first taking a log value of each individual test result and then calculating the mean of these log values.								
The 50 samples shall be derived from 10 consecutive sampling sessions in accordance with the sampling rules and frequencies laid down in this Regulation.								
The number of samples where the presence of salmonella is detected. The c value is subject to review in order to take into account the progress made in reducing the salmonella prevalence. Member States or regions having low salmonella prevalence may use lower c values even before the review.								
This criterion shall not apply to minced meat produced at retail level when the shelf-life of the product is less then 24 hours.								
E. coli is used here as an indicator of faecal contamination.								
These criteria apply to mechanically separated meat (MSM) produced with the techniques referred to in paragraph 3 of Chapter III of Section V of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council.								
Where Salmonella spp. is found, the isolates shall be further serotyped for Salmonella Typhimurium and Salmonella Enteritidis in order to verify compliance with the microbiological criterion set out in Row 1.28 of Chapter 1.								

Interpretation of the test results
The limits given refer to each sample unit tested, excluding testing of carcases where the limits refer to pooled samples.
The test results demonstrate the microbiological quality of the process tested.
Enterobacteriaceae and aerobic colony count in carcases of cattle, sheep, goats, horses and pigs:
satisfactory, if the daily mean log is ≤ m,
acceptable, if the daily mean log is between m and M,
unsatisfactory, if the daily mean log is > M.
Salmonella in carcases:
satisfactory, if the presence of Salmonella is detected in a maximum of c/n samples,
unsatisfactory, if the presence of Salmonella is detected in more than c/n samples.
After each sampling session, the results of the last ten sampling sessions shall be assessed in order to obtain the n number of samples.
E. coli and aerobic colony count in minced meat, meat preparations and mechanically separated meat (MSM):
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.
Campylobacter spp. in poultry carcases of broilers:
satisfactory, if a maximum of c/n values are > m,
unsatisfactory, if more than c/n values are > m.

2.2 Milk and dairy products
Food category	Micro-organisms	Sampling plan		Limits		Analytical reference method	Stage where the criterion applies	Action in case of unsatisfactory results
		n	c	m	M			
2.2.1 Pasteurised milk and other pasteurised liquid dairy products	Entero-bacteriaceae	5	0	10 cfu/ml		EN ISO 21528-2	End of the manufacturing process	Check on the efficiency of heat-treatment and prevention of recontamination as well as the quality of raw materials
2.2.2 Cheeses made from milk or whey that has undergone heat treatment	E. coli	5	2	100 cfu/g	1 000 cfu/g	ISO 16649-1 or 2	At the time during the manufacturing process when the E. coli count is expected to be highest	Improvements in production hygiene and selection of raw materials
2.2.3 Cheeses made from raw milk	Coagulase-positive staphylococci	5	2	104 cfu/g	105 cfu/g	EN/ISO 6888-2	At the time during the manufacturing process when the number of staphylococci is expected to be highest	Improvements in production hygiene and selection of raw materials. If values > 105 cfu/g are detected, the cheese batch has to be tested for staphylococcal enterotoxins.
2.2.4 Cheeses made from milk that has undergone a lower heat treatment than pasteurisation and ripened cheeses made from milk or whey that has undergone pasteurisation or a stronger heat treatment	Coagulase-positive staphylococci	5	2	100 cfu/g	1 000 cfu/g	EN/ISO 6888-1 or 2		
2.2.5 Unripened soft cheeses (fresh cheeses) made from milk or whey that has undergone pasteurisation or a stronger heat treatment	Coagulase-positive staphylococci	5	2	10 cfu/g	100 cfu/g	EN/ISO 6888-1 or 2	End of the manufacturing process	Improvements in production hygiene. If values > 105 cfu/g are detected, the cheese batch has to be tested for staphylococcal enterotoxins.
2.2.6 Butter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisation	E. coli	5	2	10 cfu/g	100 cfu/g	ISO 16649-1 or 2	End of the manufacturing process	Improvements in production hygiene and selection of raw materials
2.2.7 Milk powder and whey powder	Enterobacteriaceae	5	0	10 cfu/g		EN ISO 21528-2	End of the manufacturing process	Check on the efficiency of heat treatment and prevention of recontamination
	Coagulase-positive staphylococci	5	2	10 cfu/g	100 cfu/g	EN/ISO 6888-1 or 2	End of the manufacturing process	Improvements in production hygiene. If values > 105 cfu/g are detected, the batch has to be tested for staphylococcal enterotoxins.
2.2.8 Ice cream and frozen dairy desserts	Enterobacteriaceae	5	2	10 cfu/g	100 cfu/g	EN ISO 21528-2	End of the manufacturing process	Improvements in production hygiene
2.2.9 Dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age	Enterobacteriaceae	10	0	Not detected in 10 g		EN ISO 21528-1	End of the manufacturing process	Improvements in production hygiene to minimise contamination
2.2.10 Dried follow-on formulae	Enterobacteriaceae	5	0	Not detected in 10 g		EN ISO 21528-1	End of the manufacturing process	Improvements in production hygiene to minimise contamination
2.2.11 Dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age	Presumptive Bacillus cereus	5	1	50 cfu/g	500 cfu/g	EN/ISO 7932	End of the manufacturing process	Improvements in production hygiene. Prevention of recontamination. Selection of raw material.
n = number of units comprising the sample; c = number of sample units giving values between m and M.								
For points 2.2.1, 2.2.7, 2.2.9 and 2.2.10 m=M.								
The most recent edition of the standard shall be used.								
The criterion shall not apply to products intended for further processing in the food industry.								
E. coli is used here as an indicator for the level of hygiene.								
For cheeses which are not able to support the growth of E. coli, the E. coli count is usually the highest at the beginning of the ripening period, and for cheeses which are able to support the growth of E. coli, it is normally at the end of the ripening period.								
Excluding cheeses where the manufacturer can demonstrate, to the satisfaction of the competent authorities, that the product does not pose a risk of staphylococcal enterotoxins.								
Only ice creams containing milk ingredients.								
Parallel testing for Enterobacteriaceae and Cronobacter spp. shall be conducted, unless a correlation between these micro-organisms has been established at an individual plant level. If Enterobacteriaceae are detected in any of the product samples tested in such a plant, the batch has to be tested for Cronobacter spp. It shall be the responsibility of the manufacturer to demonstrate to the satisfaction of the competent authority whether such a correlation exists between Enterobacteriaceae and Cronobacter spp.								
1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter.								

Interpretation of the test results
The limits given refer to each sample unit tested.
The test results demonstrate the microbiological quality of the process tested.
Enterobacteriaceae in dried infant formulae, dried dietary foods for special medical purposes intended for infants below six months of age and dried follow-on formulae:
satisfactory, if all the values observed indicate the absence of the bacterium,
unsatisfactory, if the presence of the bacterium is detected in any of the sample units.
E. coli, Enterobacteriaceae (other food categories) and coagulase-positive staphylococci:
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.
Presumptive Bacillus cereus in dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age:
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.

2.3 Egg products
Food category	Micro-organisms	Sampling plan		Limits		Analytical reference method	Stage where the criterion applies	Action in case of unsatisfactory results
		n	c	m	M			
2.3.1 Egg products	Enterobacteriaceae	5	2	10 cfu/g or ml	100 cfu/g or ml	EN ISO 21528-2	End of the manufacturing process	Checks on the efficiency of the heat treatment and prevention of recontamination
n = number of units comprising the sample; c = number of sample units giving values between m and M.								
The most recent edition of the standard shall be used.								

Interpretation of the test results
The limits given refer to each sample unit tested.
The test results demonstrate the microbiological quality of the process tested.
Enterobacteriaceae in egg products:
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.

2.4 Fishery products
Food category	Micro-organisms	Sampling plan		Limits		Analytical reference method	Stage where the criterion applies	Action in case of unsatisfactory results
		n	c	m	M			
2.4.1. Shelled and shucked products of cooked crustaceans and molluscan shellfish	E. coli	5	2	1 MPN/g	10 MPN/g	ISO TS 16649-3	End of the manufacturing process	Improvements in production hygiene
	Coagulase-positive staphylococci	5	2	100 cfu/g	1 000 cfu/g	EN/ISO 6888-1 or 2	End of the manufacturing process	Improvements in production hygiene
n = number of units comprising the sample; c = number of sample units giving values between m and M.								
The most recent edition of the standard shall be used.								

Interpretation of the test results
The limits given refer to each sample unit tested.
The test results demonstrate the microbiological quality of the process tested.
E. coli in shelled and shucked products of cooked crustaceans and molluscan shellfish:
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.
Coagulase-positive staphylococci in shelled and cooked crustaceans and molluscan shellfish:
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.
Substituted by Corrigendum to Commission Regulation (EC) No 1441/2007 of 5 December 2007 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs (Official Journal of the European Union L 322 of 7 December 2007).

2.5 Vegetables, fruits and products thereof
Food category	Micro-organisms	Sampling plan		Limits		Analytical reference method	Stage where the criterion applies	Action in case of unsatisfactory results
		n	c	m	M			
2.5.1 Precut fruit and vegetables (ready-to-eat)	E. coli	5	2	100 cfu/g	1 000 cfu/g	ISO 16649-1 or 2	Manufacturing process	Improvements in production hygiene, selection of raw materials
2.5.2 Unpasteurised fruit and vegetable juices (ready-to-eat)	E. coli	5	2	100 cfu/g	1 000 cfu/g	ISO 16649-1 or 2	Manufacturing process	Improvements in production hygiene, selection of raw materials
n = number of units comprising the sample; c = number of sample units giving values between m and M.								
The most recent edition of the standard shall be used.								
The term unpasteurised means that the juice has not been subjected to pasteurisation obtained by time-temperature combinations or to other processes validated to achieve an equivalent bactericidal effect to pasteurisation as regards its effect on E.coli.								

Interpretation of the test results
The limits given refer to each sample unit tested.
The test results demonstrate the microbiological quality of the process tested.
E. coli in precut fruit and vegetables (ready-to-eat) and in unpasteurised fruit and vegetable juices (ready-to-eat):
satisfactory, if all the values observed are ≤ m,
acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m,
unsatisfactory, if one or more of the values observed are > M or more than c/n values are between m and M.

Chapter 3. Rules for sampling and preparation of test samples

3.1 General rules for sampling and preparation of test samples
In the absence of more specific rules on sampling and preparation of test samples, the relevant standards of the ISO (International Organisation for Standardisation) and the guidelines of the Codex Alimentarius shall be used as reference methods.

3.2 Bacteriological sampling in slaughterhouses and at premises producing minced meat, meat preparations, mechanically separated meat and fresh meat

Sampling rules for carcases of cattle, pigs, sheep, goats and horses
The destructive and non-destructive sampling methods, the selection of the sampling sites and the rules for storage and transport of samples to be used are set out in standard ISO 17604.
Five carcases shall be sampled at random during each sampling session. Sample sites must be selected taking into account the slaughter technology used in each plant.
When sampling for analyses of Enterobacteriaceae and aerobic colony counts, four sites of each carcase shall be sampled. Four tissue samples representing a total of 20 cm2 shall be obtained by the destructive method. When using the non-destructive method for this purpose, the sampling area shall cover a minimum of 100 cm2 (50 cm2 for small ruminant carcases) per sampling site.
When sampling for Salmonella analyses, an abrasive sponge sampling method shall be used. Areas most likely to be contaminated shall be selected. The total sampling area shall cover a minimum of 400 cm2.
When samples are taken from the different sampling sites on the carcase, they shall be pooled before examination.

Sampling rules for poultry carcases and fresh poultry meat
Slaughterhouses shall sample whole poultry carcases with neck skin for Salmonella and Campylobacter analyses. Cutting and processing establishments other than those adjacent to a slaughterhouse cutting and processing meat received only from this slaughterhouse, shall also take samples for Salmonella analysis. When doing so, they shall give priority to whole poultry carcases with neck skin, if available, but ensuring that also poultry portions with skin and/or poultry portions without skin or with only a small amount of skin are covered, and that choice shall be risk-based.
Slaughterhouses shall include in their sampling plans poultry carcases from flocks with an unknown Salmonella status or with a status known to be positive for Salmonella Enteritidis or Salmonella Typhimurium.
When testing against the process hygiene criteria set out in Row 2.1.5 and Row 2.1.9 of Chapter 2 for Salmonella and Campylobacter in poultry carcases in slaughterhouses and the tests for Salmonella and Campylobacter are carried out in the same laboratory, neck skins from a minimum of 15 poultry carcases shall be sampled at random after chilling during each sampling session. Before examination, the neck skin samples from at least three poultry carcases from the same flock of origin shall be pooled into one sample of 26 g. Thus, the neck skin samples form 5 × 26 g final samples (26 g are needed to perform analyses forSalmonella and Campylobacter from one sample in parallel). The samples shall be kept after sampling and transported to the laboratory at a temperature not lower than 1 °C and not higher than 8 °C and the time between the sampling and the testing for Campylobacter shall be of less than 48 hours in order to ensure maintenance of sample integrity. Samples that have reached a temperature of 0 °C shall not be used to verify compliance with the Campylobacter criterion. The 5 × 26 g samples shall be used to verify the compliance with process hygiene criteria set out in Row 2.1.5 and Row 2.1.9 of Chapter 2 and the food safety criterion set out in Row 1.28 of Chapter 1. In order to prepare the initial suspension at the laboratory, the 26 g test portion shall be transferred to nine volumes (234 ml) buffered peptone water (BPW). The BPW shall be brought to room temperature before adding. The mixture shall be treated in a stomacher or pulsifier for approximately one minute. Foaming shall be avoided by removing the air from the stomacher bag as much as possible. 10 ml (~ 1 g) of this initial suspension shall be transferred to an empty sterile tube and 1 ml of the 10 ml shall be used for the enumeration of Campylobacter on selective plates. The rest of the initial suspension (250 ml ~ 25 g) shall be used for the detection of Salmonella.
When testing against the process hygiene criteria set out in Row 2.1.5 and Row 2.1.9 of Chapter 2 for Salmonella and Campylobacter in poultry carcases in slaughterhouses and the tests for Salmonella and Campylobacter are carried out in two different laboratories, neck skins from a minimum of 20 poultry carcases shall be sampled at random after chilling during each sampling session. Before examination, the neck skin samples from at least four poultry carcases from the same flock of origin shall be pooled into one sample of 35 g. Thus, the neck skin samples form 5 × 35 g samples, which in turn shall be split in order to obtain 5 × 25 g final samples (to be tested for Salmonella) and 5 × 10 g final samples (to be tested for Campylobacter). The samples shall be kept after sampling and transported to the laboratory at a temperature not lower than 1 °C and not higher than 8 °C and the time between the sampling and the testing for Campylobacter shall be of less than 48 hours in order to ensure maintenance of sample integrity. Samples that have reached a temperature of 0 °C shall not be used to verify compliance with the Campylobacter criterion. The 5 × 25 g samples shall be used to verify the compliance with process hygiene criteria set out in Row 2.1.5 of Chapter 2 and the food safety criterion set out in Row 1.28 of Chapter 1. The 5 × 10 g final samples shall be used to verify the compliance with the process hygiene criterion set out in Row 2.1.9 of Chapter 2.
For the Salmonella analyses for fresh poultry meat other than poultry carcases, five samples of at least 25 g of the same batch shall be collected. The sample taken from poultry portions with skin shall contain skin and a thin surface muscle slice in case the amount of skin is not sufficient to form a sample unit. The sample taken from poultry portions without skin or with only a small amount of skin shall contain a thin surface muscle slice or slices added to any skin present to make a sufficient sample unit. The slices of meat shall be taken in a way that includes as much as possible of the surface of the meat.

Guidelines for sampling
More detailed guidelines on the sampling of carcases, in particular concerning the sampling sites, may be included in the guides to good practice referred to in Article 7 of Regulation (EC) No 852/2004.

Sampling frequencies for carcases, minced meat, meat preparations, mechanically separated meat and fresh poultry meat
The food business operators of slaughterhouses or establishments producing minced meat, meat preparations, mechanically separated meat or fresh poultry meat shall take samples for microbiological analysis at least once a week. The day of sampling shall be changed each week to ensure that each day of the week is covered.
As regards the sampling of minced meat and meat preparations for E. coli and aerobic colony count analyses and the sampling of carcases for Enterobacteriaceae and aerobic colony count analyses, the frequency may be reduced to fortnightly testing if satisfactory results are obtained for six consecutive weeks.
In the case of sampling for Salmonella analyses of minced meat, meat preparations, carcases and fresh poultry meat, the frequency may be reduced to fortnightly if satisfactory results have been obtained for 30 consecutive weeks. The Salmonella sampling frequency may also be reduced if there is a national or regional Salmonella control programme in place and if this programme includes testing that replaces the sampling laid down in this paragraph. The sampling frequency may be further reduced if the national or regional Salmonella control programme demonstrates that the Salmonella prevalence is low in animals purchased by the slaughterhouse.
In the case of sampling for Campylobacter analysis of poultry carcases, the frequency may be reduced to fortnightly if satisfactory results have been obtained for 52 consecutive weeks. The Campylobacter sampling frequency may be reduced, after authorisation by the competent authority, if there is an official or officially recognised national or regional Campylobacter control programme in place and if this programme includes sampling and testing equivalent to the sampling and testing required for verifying compliance with the process hygiene criterion set out in Row 2.1.9 of Chapter 2. If low contamination level of flocks is set for Campylobacter in the control programme, the sampling frequency may be further reduced if this low contamination level of Campylobacter is reached over a 52-week period in the farms of origin of the broilers purchased by the slaughterhouse. In case the control programme shows satisfactory results during a specific period of the year, frequency of analysis of Campylobacter may also be adjusted to seasonal variations after authorisation by the competent authority.
However, when justified on the basis of a risk analysis and consequently authorised by the competent authority, small slaughterhouses and establishments producing minced meat, meat preparations and fresh poultry meat in small quantities may be exempted from these sampling frequencies.
Substituted by Commission Regulation (EU) 2017/1495 of 23 August 2017 amending Regulation (EC) No 2073/2005 as regards Campylobacter in broiler carcases (Text with EEA relevance).

3.3 Sampling rules for sprouts
For the purposes of this Section, the definition of batch in Article 2(b) of Implementing Regulation (EU) No 208/2013 will apply.

A. General rules for sampling and testing

1. Preliminary testing of the batch of seeds
Food business operators producing sprouts shall carry out a preliminary testing of a representative sample of all batches of seeds. A representative sample shall include at least 0,5 % of the weight of the batch of seeds in sub samples of 50 g or be selected based on a structured statistically equivalent sampling strategy verified by the competent authority.
For the purposes of performing the preliminary testing, the food business operator must sprout the seeds in the representative sample under the same conditions as the rest of the batch of seeds to be sprouted.

2. Sampling and testing of the sprouts and the spent irrigation water
Food business operators producing sprouts shall take samples for microbiological testing at the stage where the probability of finding Shiga toxin producing E. coli (STEC) and Salmonella spp. is the highest, in any case not before 48 hours after the start of the sprouting process.
Samples of sprouts shall be analysed according to the requirements in rows 1.18 and 1.29 of Chapter 1.
However, if a food business operator producing sprouts has a sampling plan, including sampling procedures and sampling points of the spent irrigation water, they may replace the sampling requirement under the sampling plans set out in rows 1.18 and 1.29 of Chapter 1 with the analysis of 5 samples of 200 ml of the water that was used for the irrigation of the sprouts.
In that case requirements set out in rows 1.18 and 1.29 of Chapter 1 shall apply to the analysis of the water that was used for the irrigation of the sprouts, with the limit of absence in 200 ml.
When testing a batch of seeds for the first time, food business operators may only place sprouts on the market if the results of the microbiological analysis comply with rows 1.18 and 1.29 of Chapter 1, or the limit of absence in 200 ml if they analyse spent irrigation water.

3. Sampling frequency
Food business operators producing sprouts shall take samples for microbiological analysis at least once a month at the stage where the probability of finding Shiga toxin producing E. coli (STEC) and Salmonella spp. is the highest, in any case not before 48 hours after the start of the sprouting process.

B. Derogation from the preliminary testing of all batches of seeds set out in point A.1 of this Section
When justified on the basis of the following conditions and authorised by the competent authority, food business operators producing sprouts may be exempted from the sampling set out in point A.1 of this Section:
(a) the competent authority is satisfied that the food business operator implements a food safety management system in that establishment, which may include steps in the production process, which reduces the microbiological risk; and,
(b) historical data confirms that during at least 6 consecutive months prior to granting the authorisation, all batches of the different types of sprouts produced in the establishment comply with the food safety criteria set out in rows 1.18 and 1.29 of Chapter 1.
Substituted by Commission Regulation (EC) No 1441/2007 of 5 December 2007 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs (Text with EEA relevance).
ANNEX II The studies referred to in Article 3(2) shall include:
specifications for physico-chemical characteristics of the product, such as pH, aw, salt content, concentration of preservatives and the type of packaging system, taking into account the storage and processing conditions, the possibilities for contamination and the foreseen shelf-life, and
consultation of available scientific literature and research data regarding the growth and survival characteristics of the micro-organisms of concern.
When necessary on the basis of the abovementioned studies, the food business operator shall conduct additional studies, which may include:
predictive mathematical modelling established for the food in question, using critical growth or survival factors for the micro-organisms of concern in the product,
tests to investigate the ability of the appropriately inoculated micro-organism of concern to grow or survive in the product under different reasonably foreseeable storage conditions,
studies to evaluate the growth or survival of the micro-organisms of concern that may be present in the product during the shelf-life under reasonably foreseeable conditions of distribution, storage and use.
The above mentioned studies shall take into account the inherent variability linked to the product, the micro-organisms in question and the processing and storage conditions.

Inserted by Commission Regulation (EU) No 365/2010 of 28 April 2010 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs as regards Enterobacteriaceae in pasteurised milk and other pasteurised liquid dairy products and Listeria monocytogenes in food grade salt (Text with EEA relevance).
Substituted by Corrigendum to Commission Regulation (EU) No 1086/2011 of 27 October 2011 amending Annex II to Regulation (EC) No 2160/2003 of the European Parliament and of the Council and Annex I to Commission Regulation (EC) No 2073/2005 as regards salmonella in fresh poultry meat (Official Journal of the European Union L 281 of 28 October 2011).