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►B COMMISSION REGULATION (EC) No 2073/2005
of 15 November 2005
on microbiological criteria for foodstuffs
(Text with EEA relevance)
(OJ L 338, 22.12.2005, p. 1)
Amended by:
Official Journal
No page date
►M1 Commission Regulation (EC) No 1441/2007 of 5 December 2007 L 322 12 7.12.2007
►M2 Commission Regulation (EU) No 365/2010 of 28 April 2010 L 107 9 29.4.2010
Corrected by:
►C1 Corrigendum, OJ L 278, 10.10.2006, p. 32 (2073/2005)
►C2 Corrigendum, OJ L 283, 14.10.2006, p. 62 (2073/2005)
2005R2073— EN— 19.05.2010 — 002.001— 1
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 EuropeanParliament and of the Council of 29 April 2004 on the hygiene offoodstuffs (1), and in particular Articles 4(4) and 12 thereof,
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 of28 January 2002 laying down the general principles andrequirements of food law, establishing the European FoodSafety Authority and laying down procedures in matters offood safety (2). Microbiological hazards in foodstuffs form amajor source of food-borne diseases in humans.
(2) Foodstuffs should not contain micro-organisms or their toxins ormetabolites in quantities that present an unacceptable risk forhuman health.
(3) Regulation (EC) No 178/2002 lays down general food safetyrequirements, according to which food must not be placed onthe market if it is unsafe. Food business operators have an obligation to withdraw unsafe food from the market. In order tocontribute to the protection of public health and to preventdiffering interpretations, it is appropriate to establish harmonisedsafety criteria on the acceptability of food, in particular as regardsthe presence of certain pathogenic micro-organisms.
(4) Microbiological criteria also give guidance on the acceptability offoodstuffs and their manufacturing, handling and distributionprocesses. The use of microbiological criteria should form anintegral part of the implementation of HACCP-based proceduresand other hygiene control measures.
(5) The safety of foodstuffs is mainly ensured by a preventiveapproach, such as implementation of good hygiene practice andapplication of procedures based on hazard analysis and criticalcontrol point (HACCP) principles. Microbiological criteria can beused in validation and verification of HACCP procedures andother hygiene control measures. It is therefore appropriate toset microbiological criteria defining the acceptability of theprocesses, and also food safety microbiological criteria setting alimit above which a foodstuff should be considered unacceptablycontaminated with the micro-organisms for which the criteria areset.
(6) According to Article 4 of Regulation (EC) No 852/2004, foodbusiness operators are to comply with microbiological criteria.This should include testing against the values set for thecriteria through the taking of samples, the conduct of analysesand the implementation of corrective actions, in accordance withfood law and the instructions given by the competent authority. Itis therefore appropriate to lay down implementing measures
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2005R2073— EN— 19.05.2010 — 002.001— 2
(1) OJ L 139, 30.4.2004, p. 1, corrected by OJ L 226, 25.6.2004, p. 3.(2) 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).
concerning the analytical methods, including, where necessary,the measurement uncertainty, the sampling plan, the microbiological limits, the number of analytical units that shouldcomply with these limits. Furthermore, it is appropriate to laydown implementing measures concerning the foodstuff to whichthe criterion applies, the points of the food chain where thecriterion applies, as well as the actions to be taken when thecriterion is not met. The measures to be taken by the foodbusiness operators in order to ensure compliance with criteriadefining the acceptability of a process may include, amongother things, controls of raw materials, hygiene, temperatureand shelf-life of the product.
(7) Regulation (EC) No 882/2004 of the European Parliament and ofthe Council of 29 April 2004 on official controls performed toensure the verification of compliance with feed and food law,animal health and animal welfare rules (1) requires the MemberStates to ensure that official controls are carried out regularly, ona risk basis and with appropriate frequency. Those controlsshould take place at appropriate stages of the production,processing and distribution of food to ensure that the criterialaid down in this Regulation are complied with by foodbusiness operators.
(8) The Communication from the Commission on the CommunityStrategy for setting microbiological criteria for foodstuffs (2)describes the strategy to lay down and revise the criteria inCommunity legislation, as well as the principles for the development and application of the criteria. This strategy should beapplied when microbiological criteria are laid down.
(9) The Scientific Committee on Veterinary Measures relating toPublic Health (SCVPH) issued an opinion on 23 September1999 on the evaluation of microbiological criteria for foodproducts of animal origin for human consumption. It highlightedthe relevance of basing microbiological criteria on formal riskassessment and internationally approved principles. The opinionrecommends that microbiological criteria should be relevant andeffective in relation to consumer health protection. The SCVPHproposed, while awaiting formal risk assessments, certain revisedcriteria as interim measures.
(10) The SCVPH issued at the same time a separate opinion onListeria monocytogenes. That opinion recommended that it bean objective to keep the concentration of Listeria monocytogenesin food below 100 cfu/g. The Scientific Committee on Food(SCF) agreed with these recommendations in its opinion of22 June 2000.
(11) The SCVPH adopted an opinion on Vibrio vulnificus and Vibrioparahaemolyticus on 19 and 20 September 2001. It concludedthat currently available scientific data do not support settingspecific criteria for pathogenic V. vulnificus and parahaemolyticus in seafood. However, it recommended that codes ofpractice should be established to ensure that good hygienepractice has been applied.
(12) The SCVPH issued an opinion on Norwalk-like viruses (NLVs,noroviruses) on 30-31 January 2002. In that opinion it concludedthat the conventional faecal indicators are unreliable for demonstrating the presence or absence of NLVs and that the reliance onfaecal bacterial indicator removal for determining shellfish purification times is unsafe practice. It also recommended using E.
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(1) OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004, p. 1.(2) SANCO/1252/2001 Discussion paper on strategy for setting microbiological
criteria for foodstuffs in Community legislation, p. 34.
coli rather than faecal coliforms to indicate faecal contaminationin 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 thatthe microbiological criteria set in Chapter 4 of Annex II toCouncil Directive 92/118/EEC of 17 December 1992 layingdown animal health and public health requirements governingtrade in and imports into the Community of products notsubject to the said requirements laid down in specificCommunity rules referred to in Annex A(I) to Directive89/662/EEC and, as regards pathogens, to Directive90/425/EEC (1) in terms of consumer health were excessive,and considered it sufficient to apply a mandatory microbiologicalcriterion for salmonella only.
(14) The SCVPH issued an opinion on verotoxigenic E. coli (VTEC)in foodstuffs on 21 and 22 January 2003. In its opinion itconcluded that applying an end-product microbiologicalstandard for VTEC O157 is unlikely to deliver meaningfulreductions 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 inpublic health risks, including VTEC. The SCVPH identified thefollowing food categories where VTEC represents a hazard topublic health: raw or undercooked beef and possibly meat fromother ruminants, minced meat and fermented beef and productsthereof, raw milk and raw milk products, fresh produce, inparticular sprouted seeds, and unpasteurised fruit and vegetablejuices.
(15) On 26 and 27 March 2003 the SCVPH adopted an opinion onstaphylococcal enterotoxins in milk products, particularly incheeses. It recommended revising the criteria for coagulase-positive staphylococci in cheeses, in raw milk intended forprocessing and in powdered milk. In addition, criteria for staphylococcal enterotoxins should be laid down for cheeses andpowdered milk.
(16) The SCVPH adopted an opinion on salmonellae in foodstuffs on14 and 15 April 2003. According to the opinion, food categoriespossibly posing a high risk to public health include raw meat andsome products intended to be eaten raw, raw and undercookedproducts of poultry meat, eggs and products containing raw eggs,unpasteurised milk and some products thereof. Sprouted seedsand unpasteurised fruit juices are also of concern. It recommended that the decision on the need for microbiologicalcriteria should be taken on the basis of its ability to protect theconsumers and its feasibility.
(17) The Scientific Panel on Biological Hazards (BIOHAZ Panel) ofthe European Food Safety Authority (EFSA) issued an opinion onthe microbiological risks in infant formulae and follow-onformulae on 9 September 2004. It concluded that Salmonellaand Enterobacter sakazakii are the micro-organisms of greatestconcern in infant formulae, formulae for special medical purposesand follow-on formulae. The presence of these pathogensconstitutes a considerable risk if conditions after reconstitutionpermit multiplication. Enterobacteriaceae, which are more oftenpresent, could be used as an indicator for risk. Monitoring andtesting of Enterobacteriaceae was recommended in both themanufacturing environment and the finished product by theEFSA. However, besides pathogenic species the family Enterobacteriaceae includes also environmental species, which oftenappear in the food manufacturing environment without posing
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(1) 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).
any health hazard. Therefore, the family Enterobacteriaceae canbe used for routine monitoring, and if they are present testing ofspecific pathogens can be started.
(18) International guidelines for microbiological criteria in respect ofmany foodstuffs have not yet been established. However, theCommission 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 ofdried milk products, foods for infants and children and thehistamine criterion for certain fish and fishery products havebeen taken account. The adoption of Community criteria shouldbenefit trade by providing harmonised microbiologicalrequirements for foodstuffs and replacing national criteria.
(19) The microbiological criteria set for certain categories of food ofanimal origin in Directives that were repealed by Directive2004/41/EC of the European Parliament and of the Council of21 April 2004 repealing certain Directives concerning foodhygiene and health conditions for the production and placingon the market of certain products of animal origin intended forhuman consumption and amending Council Directives89/662/EEC and 92/118/EEC and Council Decision95/408/EC (1) should be revised and certain new criteria set inthe light of the scientific advice.
(20) The microbiological criteria laid down in Commission Decision93/51 EEC of 15 December 1992 on the microbiological criteriaapplicable to the production of cooked crustaceans and molluscanshellfish (2) are incorporated in this Regulation. It is thereforeappropriate to repeal that Decision. Since Commission Decision2001/471/EC of 8 June 2001 laying down rules for the regularchecks on the general hygiene carried out by the operators inestablishments according to Directive 64/433/EEC on healthconditions for the production and marketing of fresh meat andDirective 71/118/EEC on health problems affecting theproduction and placing on the market of fresh poultrymeat (3) isrepealed with effect from the 1 January 2006, it is appropriate toincorporate microbiological criteria set for carcases in this Regulation.
(21) The producer or manufacturer of a food product has to decidewhether the product is ready to be consumed as such, without theneed to cook or otherwise process it in order to ensure its safetyand compliance with the microbiological criteria. According toArticle 3 of Directive 2000/13/EC of the European Parliamentand of the Council of 20 March 2000 on the approximation ofthe laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (4), the instructions for use ofa foodstuff are compulsory on the labelling when it would beimpossible to make appropriate use of the foodstuff in theabsence of such instructions. Such instructions should be takeninto account by food business operators when deciding appropriate sampling frequencies for the testing against microbiologicalcriteria.
(22) Sampling of the production and processing environment can be auseful tool to identify and prevent the presence of pathogenicmicro-organisms in foodstuffs.
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(1) OJ L 157, 30.4.2004, p. 33, corrected by OJ L 195, 2.6.2004, p. 12.(2) OJ L 13, 21.1.1993, p. 11.(3) OJ L 165, 21.6.2001, p. 48. Decision as amended by Decision 2004/379/EC
(OJ L 144, 30.4.2004, p. 1).(4) 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).
(23) Food business operators should decide themselves the necessarysampling and testing frequencies as part of their procedures basedon HACCP principles and other hygiene control procedures.However, it may be necessary in certain cases to set harmonisedsampling frequencies at Community level, particularly in order toensure the same level of controls to be performed throughout theCommunity.
(24) Test results are dependent on the analytical method used, andtherefore a given reference method should be associated witheach microbiological criterion. However, food businessoperators should have the possibility to use analytical methodsother than the reference methods, in particular more rapidmethods, as long as the use of these alternative methodsprovides equivalent results. Moreover, a sampling plan needs tobe defined for each criterion in order to ensure harmonised implementation. It is nevertheless necessary to allow the use of othersampling and testing schemes, including the use of alternativeindicator organisms, on condition that these schemes provideequivalent guarantees of food safety.
(25) Trends in test results should be analysed, as they are able toreveal unwanted developments in the manufacturing processenabling the food business operator to take corrective actionsbefore the process is out of control.
(26) The microbiological criteria set in this Regulation should be opento review and revised or supplemented, if appropriate, in order totake into account developments in the field of food safety andfood microbiology. This includes progress in science, technologyand methodology, changes in prevalence and contaminationlevels, changes in the population of vulnerable consumers, aswell as the possible outputs from risk assessments.
(27) In particular, criteria for pathogenic viruses in live bivalvemolluscs should be established when the analytical methods aredeveloped sufficiently. There is a need for development ofreliable methods for other microbial hazards too, e.g. Vibrioparahaemolyticus.
(28) It has been demonstrated that the implementation of controlprogrammes can markedly contribute to a reduction of theprevalence of salmonella in production animals and productsthereof. The purpose of Regulation (EC) No 2160/2003 of theEuropean Parliament and of the Council of 17 November 2003on the control of salmonella and other specified food-bornezoonotic agents (1) is to ensure that proper and effectivemeasures are taken to control salmonella at relevant stages ofthe food chain. Criteria for meat and products thereof shouldtake into account the expected improvement in the salmonellasituation at the level of primary production.
(29) For certain food safety criteria, it is appropriate to grant theMember States a transitional derogation, enabling them tocomply with less stringent criteria but provided that the foodstuffswould only be marketed on the national market. The MemberStates should notify the Commission and other Member Stateswhere this transitional derogation is used.
(30) The measures provided for in this Regulation are in accordancewith the opinion of the Standing Committee on the Food Chainand Animal Health,
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(1) OJ L 325, 12.12.2003, p. 1.
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 foodbusiness operators when implementing the general and specifichygiene measures referred to in Article 4 of Regulation (EC) No852/2004. The competent authority shall verify compliance with therules and criteria laid down in this Regulation in accordance withRegulation (EC) No 882/2004, without prejudice to its right toundertake further sampling and analyses for the purpose of detectingand measuring other micro-organisms, their toxins or metabolites, eitheras a verification of processes, for food suspected of being unsafe, or inthe context of a risk analysis.
This Regulation shall apply without prejudice to other specific rules forthe control of micro-organisms laid down in Community legislation andin particular the health standards for foodstuffs laid down in Regulation(EC) No 853/2004 of the European Parliament and of the Council (1),the rules on parasites laid down under Regulation (EC) No 854/2004 ofthe European Parliament and of the Council (2) and the microbiologicalcriteria laid down under Council Directive 80/777/EEC (3).
Article 2
Definitions
The following definitions shall apply:
(a) ‘micro-organisms’ means bacteria, viruses, yeasts, moulds, algae,parasitic protozoa, microscopic parasitic helminths, and theirtoxins and metabolites;
(b) ‘microbiological criterion’ means a criterion defining the acceptability of a product, a batch of foodstuffs or a process, based onthe absence, presence or number of micro-organisms, and/or on thequantity of their toxins/metabolites, per unit(s) of mass, volume,area or batch;
(c) ‘food safety criterion’ means a criterion defining the acceptability ofa product or a batch of foodstuff applicable to products placed onthe market;
(d) ‘process hygiene criterion’ a criterion indicating the acceptable functioning of the production process. Such a criterion is not applicableto products placed on the market. It sets an indicative contaminationvalue above which corrective actions are required in order tomaintain the hygiene of the process in compliance with food law;
(e) ‘batch’ means a group or set of identifiable products obtained froma given process under practically identical circumstances andproduced in a given place within one defined production period;
(f) ‘shelf-life’ means either the period corresponding to the periodpreceding the ‘use by’ or the minimum durability date, as definedrespectively in Articles 9 and 10 of Directive 2000/13/EC;
(g) ‘ready-to-eat food’ means food intended by the producer or themanufacturer for direct human consumption without the need forcooking or other processing effective to eliminate or reduce to anacceptable level micro-organisms of concern;
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(1) OJ L 139, 30.4.2004, p. 55, corrected by OJ L 226, 25.6.2004, p. 22.(2) OJ L 139, 30.4.2004, p. 206, corrected by OJ L 226, 25.6.2004, p. 83.(3) OJ L 229, 30.8.1980, p. 1.
(h) ‘food intended for infants’ means food specifically intended forinfants, as defined in Commission Directive 91/321/EEC (1);
(i) ‘food intended for special medical purposes’ means dietary food forspecial medical purposes, as defined in Commission Directive1999/21/EC (2);
(j) ‘sample’ means a set composed of one or several units or a portionof matter selected by different means in a population or in animportant quantity of matter, which is intended to provide information on a given characteristic of the studied population or matterand to provide a basis for a decision concerning the population ormatter in question or concerning the process which has produced it;
(k) ‘representative sample’ means a sample in which the characteristicsof the batch from which it is drawn are maintained. This is inparticular the case of a simple random sample where each of theitems 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 againstthe values set for the criteria through the taking of samples, theconduct of analyses and the implementation of corrective action, inaccordance with food law and the instructions given by thecompetent authority.
Article 3
General requirements
1. Food business operators shall ensure that foodstuffs comply withthe relevant microbiological criteria set out in Annex I. To this end thefood business operators at each stage of food production, processing anddistribution, including retail, shall take measures, as part of theirprocedures 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 theprocess hygiene criteria are met,
(b) that the food safety criteria applicable throughout the shelf-life ofthe products can be met under reasonably foreseeable conditions ofdistribution, storage and use.
2. As necessary, the food business operators responsible for themanufacture of the product shall conduct studies in accordance withAnnex II in order to investigate compliance with the criteria throughoutthe shelf-life. In particular, this applies to ready-to-eat foods that areable to support the growth of Listeria monocytogenes and that may posea Listeria monocytogenes risk for public health.
Food businesses may collaborate in conducting those studies.
Guidelines for conducting those studies may be included in the guidesto good practice referred to in Article 7 of Regulation (EC) No852/2004.
Article 4
Testing against criteria
1. Food business operators shall perform testing as appropriateagainst the microbiological criteria set out in Annex I, when they are
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(1) OJ L 175, 4.7.1991, p. 35.(2) OJ L 91, 7.4.1999, p. 29.
validating or verifying the correct functioning of their procedures basedon HACCP principles and good hygiene practice.
2. Food business operators shall decide the appropriate samplingfrequencies, except where Annex I provides for specific samplingfrequencies, in which case the sampling frequency shall be at leastthat provided for in Annex I. Food business operators shall make thisdecision in the context of their procedures based on HACCP principlesand good hygiene practice, taking into account the instructions for useof the foodstuff.
The frequency of sampling may be adapted to the nature and size of thefood businesses, provided that the safety of foodstuffs will not beendangered.
Article 5
Specific rules for testing and sampling
1. The analytical methods and the sampling plans and methods inAnnex I shall be applied as reference methods.
2. Samples shall be taken from processing areas and equipment usedin food production, when such sampling is necessary for ensuring thatthe criteria are met. In that sampling the ISO standard 18593 shall beused as a reference method.
Food business operators manufacturing ready-to-eat foods, which maypose a Listeria monocytogenes risk for public health, shall sample theprocessing areas and equipment for Listeria monocytogenes as part oftheir sampling scheme.
Food business operators manufacturing dried infant formulae or driedfoods for special medical purposes intended for infants below sixmonths which pose an Enterobacter sakazakii risk shall monitor theprocessing areas and equipment for Enterobacteriaceae as part oftheir sampling scheme.
3. The number of sample units of the sampling plans set out inAnnex I may be reduced if the food business operator can demonstrateby historical documentation that he has effective HACCP-basedprocedures.
4. If the aim of the testing is to specifically assess the acceptability ofa certain batch of foodstuffs or a process, the sampling plans set out inAnnex I shall be respected as a minimum.
5. Food business operators may use other sampling and testingprocedures, if they can demonstrate to the satisfaction of thecompetent authority that these procedures provide at least equivalentguarantees. Those procedures may include use of alternative samplingsites and use of trend analyses.
Testing against alternative micro-organisms and related microbiologicallimits as well as testing of analytes other than microbiological ones shallbe allowed only for process hygiene criteria.
The use of alternative analytical methods is acceptable when themethods are validated against the reference method in Annex I and ifa proprietary method, certified by a third party in accordance with theprotocol set out in EN/ISO standard 16140 or other internationallyaccepted similar protocols, is used.
If the food business operator wishes to use analytical methods otherthan those validated and certified as described in paragraph 3 themethods shall be validated according to internationally acceptedprotocols and their use authorised by the competent authority.
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Article 6
Labelling requirements
1. When the requirements for Salmonella in minced meat, meatpreparations and meat products intended to be eaten cooked of allspecies set down in Annex I are fulfilled, the batches of thoseproducts placed on the market must be clearly labelled by the manufacturer in order to inform the consumer of the need for thoroughcooking prior to consumption.
2. As from 1 January 2010 labelling as referred to in paragraph 1 inrespect of minced meat, meat preparations and meat products madefrom poultrymeat will no longer be required.
Article 7
Unsatisfactory results
1. When the results of testing against the criteria set out in Annex Iare unsatisfactory, the food business operators shall take the measureslaid down in paragraphs 2 to 4 of this Article together with othercorrective actions defined in their HACCP-based procedures and otheractions 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 unacceptablemicrobiological contamination. Those measures may include modifications to the HACCP-based procedures or other food hygiene controlmeasures in place.
2. When testing against food safety criteria set out in Chapter 1 ofAnnex I provides unsatisfactory results, the product or batch of foodstuffs shall be withdrawn or recalled in accordance with Article 19 ofRegulation (EC) No 178/2002. However, products placed on the market,which are not yet at retail level and which do not fulfil the food safetycriteria, may be submitted to further processing by a treatment eliminating the hazard in question. This treatment may only be carried out byfood business operators other than those at retail level.
The food business operator may use the batch for purposes other thanthose for which it was originally intended, provided that this use doesnot pose a risk for public or animal health and provided that this use hasbeen decided within the procedures based on HACCP principles andgood hygiene practice and authorised by the competent authority.
3. A batch of mechanically separated meat (MSM) produced with thetechniques referred to in Chapter III, paragraph 3, in Section V ofAnnex III to Regulation (EC) No 853/2004, with unsatisfactoryresults in respect of the Salmonella criterion, may be used in the foodchain only to manufacture heat-treated meat products in establishmentsapproved in accordance with Regulation (EC) No 853/2004.
4. In the event of unsatisfactory results as regards process hygienecriteria 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 thelatest pursuant to Article 12 of Regulation (EC) No 852/2004 as regardscompliance with the value set in Annex I to this Regulation forSalmonella in minced meat, meat preparations and meat productsintended to be eaten cooked placed on the national market of aMember State.
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2. The Member States using this possibility shall notify theCommission and other Member States thereof. The Member State shall:
(a) guarantee that the appropriate means, including labelling and aspecial mark, which cannot be confused with the identificationmark provided for in Annex II, Section I to Regulation (EC) No853/2004, are in place to ensure that the derogation applies only tothe products concerned when placed on the domestic market, andthat products dispatched for intra-Community trade comply with thecriteria laid down in Annex I;
(b) provide that the products to which such transitional derogationapplies shall be clearly labelled that they must be thoroughlycooked prior to consumption;
(c) undertake that when testing against the Salmonella criterionpursuant to Article 4, and for the result to be acceptable asregards such transitional derogation, no more than one out of fivesample units shall be found to be positive.
Article 9
Analyses of trends
Food business operators shall analyse trends in the test results. Whenthey observe a trend towards unsatisfactory results, they shall takeappropriate actions without undue delay to remedy the situation inorder to prevent the occurrence of microbiological risks.
Article 10
Review
This Regulation shall be reviewed taking into account progress inscience, technology and methodology, emerging pathogenic micro-organisms in foodstuffs, and information from risk assessments. Inparticular, the criteria and conditions concerning the presence ofsalmonella in carcases of cattle, sheep, goats, horses, pigs and poultryshall be revised in the light of the changes observed in salmonellaprevalence.
Article 11
Repeal
Decision 93/51/EEC is repealed.
Article 12
This Regulation shall enter into force on the 20th day following itspublication 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 inall Member States.
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2005R2073— EN— 19.05.2010 — 002.001 — 11
ANNEX I
Microbiological criteria for foodstuffs
Chapter 1. Food safety criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 2. Process hygiene criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.1 Meat and products thereof . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2 Milk and dairy products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.3 Egg products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.4 Fishery products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5 Vegetables, fruits and products thereof . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chapter 3. Rules for sampling and preparation of test samples . . . . . . . . . . . . . . . . . . . . . .
3.1 General rules for sampling and preparation of test samples . . . . . . . . . . . . . . . . .
3.2 Bacteriological sampling in slaughterhouses and at premises producing minced meatand meat preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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2005R2073— EN — 19.05.2010 — 002.001— 13
Chap
ter1.
Foo
dsafety
criteria
Foo
dcatego
ryMicro-organisms/their
toxins,metabolites
Sam
pling
plan
(1)
Lim
its(2)
Analytical
reference
metho
d(3)
Stage
where
thecriterion
applies
nc
mM
1.1
Ready
-to-eatfood
sintend
edforinfantsandready-
to-eat
food
sforspecialmedical
purposes
(4)
Listeriamon
ocytog
enes
100
Absence
in25
gEN/ISO
1129
0-1
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.2
Ready
-to-eatfoodsable
tosupp
ortthegrow
thof
L.
mon
ocytog
enes,
other
than
those
intend
edfor
infantsandforspecialmedical
purposes
Listeriamon
ocytog
enes
50
100cfu/g(5)
EN/ISO
1129
0-2(6)
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
50
Absence
in25
g(7)
EN/ISO
1129
0-1
Beforethefood
haslefttheim
mediate
controlof
thefood
business
operator,
who
hasprod
uced
it
1.3
Ready
-to-eatfood
sun
able
tosupp
ortthegrow
thof
L.mon
ocytog
enes,otherthan
thoseintend
edfor
infantsandforspecialmedical
purposes
(4)(8)
Listeriamon
ocytog
enes
50
100cfu/g
EN/ISO
1129
0-2(6)
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.4
Mincedmeatandmeatpreparations
intend
edto
beeatenraw
Salmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
▼M2
1.5
Minced
meatand
meatpreparations
made
from
poultrymeatintend
edto
beeatencook
edSa
lmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
▼M1
1.6
Minced
meatand
meatpreparations
made
from
otherspeciesthan
poultry
intend
edto
beeaten
cook
ed
Salmon
ella
50
Absence
in10
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.7
Mechanically
separatedmeat(M
SM)(9)
Salmon
ella
50
Absence
in10
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.8
Meatprod
ucts
intend
edto
beeatenraw,exclud
ing
prod
ucts
where
themanufacturing
processor
the
compo
sitio
nof
the
prod
uct
will
elim
inate
the
salm
onella
risk
Salmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 14
Foo
dcatego
ryMicro-organisms/their
toxins,metabolites
Sam
pling
plan
(1)
Lim
its(2)
Analytical
reference
metho
d(3)
Stage
where
thecriterion
applies
nc
mM
▼M2
1.9
Meatprod
uctsmadefrom
poultrymeatintend
edto
beeatencook
edSa
lmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
▼M1
1.10
Gelatineandcollagen
Salmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.11
Cheeses,bu
tterandcream
madefrom
raw
milk
ormilk
that
hasun
dergon
ealower
heat
treatm
ent
than
pasteurisatio
n(10 )
Salmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.12
Milk
powderandwheypo
wder
Salmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.13
Icecream
(11 ),exclud
ingprod
uctswhere
themanu
facturingprocessor
thecompo
sitio
nof
theprod
uct
will
elim
inatethesalm
onella
risk
Salmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.14
Egg
products,excludingproductswhere
themanu
facturingprocessor
thecompo
sitio
nof
theprod
uct
will
elim
inatethesalm
onella
risk
Salmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.15
Ready
-to-eatfood
scontaining
raw
egg,
exclud
ing
prod
ucts
where
themanufacturing
processor
the
compo
sitio
nof
the
prod
uct
will
elim
inate
the
salm
onella
risk
Salmon
ella
50
Absence
in25
gor
ml
EN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.16
Coo
kedcrustaceansandmolluscan
shellfish
Salmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.17
Live
bivalve
molluscs
and
live
echino
derm
s,tunicatesandgastropo
dsSa
lmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.18
Sproutedseeds(ready-to-eat)(12 )
Salmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.19
Precutfruitandvegetables
(ready-to-eat)
Salmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 15
Foo
dcatego
ryMicro-organisms/their
toxins,metabolites
Sam
pling
plan
(1)
Lim
its(2)
Analytical
reference
metho
d(3)
Stage
where
thecriterion
applies
nc
mM
1.20
Unp
asteurised
fruitandvegetablejuices
(ready
-to-
eat)
Salmon
ella
50
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.21
Cheeses,
milk
powder
and
whey
powder,
asreferred
toin
thecoagulase-positiv
estaphylococci
criteriain
Chapter
2.2of
this
Ann
ex
Staph
ylococcal
entero
toxins
50
Not
detected
in25
gEurop
eanscreening
metho
dof
theCRL
forcoagulase
positiv
estaphy
lococci(
13)
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.22
Dried
infant
form
ulae
anddrieddietaryfood
sfor
special
medical
purposes
intend
edfor
infants
below
sixmon
thsof
age
Salmon
ella
300
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.23
Dried
follo
w-onform
ulae
Salmon
ella
300
Absence
in25
gEN/ISO
6579
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
▼M2
1.24
Dried
infant
form
ulae
anddrieddietaryfood
sfor
special
medical
purposes
intend
edfor
infants
below
6mon
thsof
age
(14 )
Crono
bacter
spp.
(Enterob
acter
sakazakii)
300
Absence
in10
gISO/TS22
964
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
▼M1
1.25
Live
bivalve
molluscs
and
live
echino
derm
s,tunicatesandgastropo
dsE.coli(1
5 )1(1
6 )0
230MPN/100
gof
flesh
andintra-valvular
liquid
ISO
TS16
649-3
Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
1.26
Fishery
prod
ucts
from
fish
speciesassociated
with
ahigh
amou
ntof
histidine(1
7 )Histamine
9(1
8 )2
100mg/kg
200mg/kg
HPLC(1
9 )Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 16
Foo
dcatego
ryMicro-organisms/their
toxins,metabolites
Sam
pling
plan
(1)
Lim
its(2)
Analytical
reference
metho
d(3)
Stage
where
thecriterion
applies
nc
mM
1.27
Fishery
prod
ucts
which
have
undergon
eenzyme
maturationtreatm
entin
brine,
manufacturedfrom
fish
species
associated
with
ahigh
amou
ntof
histidine(17 )
Histamine
92
200mg/kg
400mg/kg
HPLC(1
9 )Produ
ctsplaced
onthemarketdu
ring
theirshelf-life
(1)n=nu
mberof
units
comprisingthesample;
c=nu
mberof
sampleun
itsgiving
values
betweenm
andM.
(2)For
points
1.1-1.25
m=M.
(3)The
mostrecent
edition
ofthestandard
shallbe
used.
(4)Regular
testingagainstthecriterion
isno
trequ
ired
inno
rmal
circum
stancesforthefollo
wingready-to-eat
food
s:—
thosewhich
have
received
heat
treatm
entor
otherprocessing
effectiveto
elim
inateL.mon
ocytog
enes,whenrecontam
inationis
notpo
ssible
afterthis
treatm
ent(for
exam
ple,
prod
ucts
heat
treatedin
theirfinal
package),
—fresh,
uncutandun
processedvegetables
andfruits,exclud
ingsprouted
seeds,
—bread,
biscuits
andsimilarprod
ucts,
—bo
ttled
orpacked
waters,
softdrinks,beer,cider,wine,
spirits
andsimilarprod
ucts,
—sugar,ho
neyandconfectio
nery,includ
ingcocoaandchocolateprod
ucts,
—liv
ebivalvemolluscs,
►M2
—food
gradesalt.
◄(5)Thiscriterion
shallapplyifthemanufactureris
able
todemon
strate,to
thesatisfactionof
thecompetent
authority
,that
theprod
uctwill
notexceed
thelim
it10
0cfu/gthroug
hout
theshelf-life.
The
operator
may
fix
interm
ediate
limits
during
theprocessthat
mustbe
low
enou
ghto
guaranteethat
thelim
itof
100cfu/gis
notexceeded
attheendof
shelf-life.
(6)1mlof
inoculum
isplated
onaPetridish
of14
0mm
diam
eter
oron
threePetridishes
of90
mm
diam
eter.
(7)Thiscriterion
shallapplyto
prod
ucts
before
they
have
lefttheim
mediate
controlof
theprod
ucingfood
business
operator,whenhe
isno
table
todemon
strate,to
thesatisfactionof
thecompetent
authority
,that
the
prod
uctwill
notexceed
thelim
itof
100cfu/gthroug
hout
theshelf-life.
(8)Produ
ctswith
pH≤4,4or
a w≤0,92
,prod
uctswith
pH≤5,0anda w
≤0,94
,prod
uctswith
ashelf-lifeof
less
than
five
days
shallbe
automatically
considered
tobelong
tothiscatego
ry.Other
catego
ries
ofprod
ucts
canalso
belong
tothis
catego
ry,subjectto
scientific
justification.
(9)Thiscriterion
shallapplyto
mechanically
separatedmeat(M
SM)prod
uced
with
thetechniqu
esreferred
toin
paragraph3of
Chapter
IIIof
Sectio
nV
ofAnn
exIIIto
Regulation(EC)No85
3/20
04of
theEurop
ean
Parliamentandof
theCou
ncil.
(10 )Excluding
prod
ucts
whenthemanufacturercandemon
strate
tothesatisfactionof
thecompetent
authorities
that,du
eto
theripening
timeanda w
oftheprod
uctwhere
approp
riate,
thereis
nosalm
onella
risk.
(11 )Onlyicecreamscontaining
milk
ingredients.
(12 )Prelim
inarytestingof
thebatchof
seedsbefore
startin
gthesproutingprocessor
thesamplingmustbe
carriedou
tat
thestagewhere
thehigh
estprob
ability
offind
ingSalmon
ella
isexpected.
(13 )Reference:Com
mun
ityreferencelabo
ratory
forcoagulasepo
sitiv
estaphy
lococci.Europ
eanscreeningmetho
dforthedetectionof
staphy
lococcal
enterotoxins
inmilk
andmilk
prod
ucts.
(14 )ParalleltestingforEnterob
acteriaceaeandE.sakazakiishallbe
cond
ucted,
unless
acorrelationbetweenthesemicro-organismshasbeen
establishedat
anindividu
alplantlevel.If
Enterob
acteriaceaearedetected
inanyof
theprod
uctsamples
tested
insuch
aplant,thebatchmustbe
tested
forE.sakazakii.Itshallbe
therespon
sibilityof
themanufacturerto
demon
strate
tothesatisfactionof
thecompetent
authority
whether
such
acorrelationexists
betweenEnterob
acteriaceaeandE.sakazakii.
(15 )E.coliis
used
here
asan
indicatorof
faecal
contam
ination.
(16 )A
pooled
samplecomprisingaminim
umof
10individu
alanim
als.
(17 )Particularly
fish
speciesof
thefamilies:Scom
bridae,Clupeidae,Eng
raulidae,Coryfenidae,Pom
atom
idae,Scom
bresosidae.
(18 )Singlesamples
may
betakenat
retaillevel.In
such
acase
thepresum
ptionlaid
downin
Article
14(6)of
Regulation(EC)No17
8/20
02,accordingto
which
thewho
lebatchis
tobe
deem
edun
safe,shallno
tapply.
(19 )References:
1.Malle
P.,Valle
M.,Bou
quelet
S.Assay
ofbiog
enic
amines
invo
lved
infish
decompo
sitio
n.J.AOAC
Internat.19
96,79
,43
-49.
2.DuflosG.,DervinC.,Malle
P.,Bou
quelet
S.Relevance
ofmatrix
effect
indeterm
inationof
biog
enic
amines
inplaice
(Pleuron
ectesplatessa)andwhitin
g(M
erlang
usmerlang
us.J.
AOAC
Internat.19
99,82
,10
97-110
1.
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 17
Interpretation
ofthetest
results
The
limits
givenreferto
each
sampleun
ittested,exclud
ingliv
ebivalvemolluscsandliv
eechino
derm
s,tunicatesandgastropo
dsin
relatio
nto
testingE.coli,where
thelim
itrefers
toapo
oled
sample.
The
test
results
demon
strate
themicrobiolog
ical
quality
ofthebatchtested
(1).
L.mon
ocytog
enes
inready-to-eat
food
sintend
edforinfantsandforspecialmedical
purposes:
—satisfactory,
ifallthevalues
observed
indicate
theabsenceof
thebacterium,
—un
satisfactory,
ifthepresence
ofthebacterium
isdetected
inanyof
thesampleun
its.
L.mon
ocytog
enes
inready-to-eat
foodsable
tosupportthegrow
thof
L.mon
ocytog
enes
before
thefood
haslefttheim
mediate
controlof
theproducingfood
business
operator
whenhe
isnot
able
todemonstrate
that
theproductwill
notexceed
thelim
itof
100cfu/gthroughout
theshelf-life:
—satisfactory,
ifallthevalues
observed
indicate
theabsenceof
thebacterium,
—un
satisfactory,
ifthepresence
ofthebacterium
isdetected
inanyof
thesampleun
its.
L.mon
ocytog
enes
inotherready-to-eat
foodsandE.coliin
livebivalvemolluscs:
—satisfactory,
ifallthevalues
observed
are≤thelim
it,
—un
satisfactory,
ifanyof
thevalues
are>thelim
it.
Salmon
ella
indifferentfood
catego
ries:
—satisfactory,
ifallthevalues
observed
indicate
theabsenceof
thebacterium,
—un
satisfactory,
ifthepresence
ofthebacterium
isdetected
inanyof
thesampleun
its.
Staph
ylococcalenterotoxins
indairyprod
ucts:
—satisfactory,
ifin
allthesampleun
itstheenterotoxins
areno
tdetected,
—un
satisfactory,
iftheenterotoxins
aredetected
inanyof
thesampleun
its.
Enterob
actersakazakiiin
driedinfant
form
ulae
anddrieddietaryfood
sforspecialmedical
purposes
intend
edforinfantsbelow
6mon
thsof
age:
—satisfactory,
ifallthevalues
observed
indicate
theabsenceof
thebacterium,
—un
satisfactory,
ifthepresence
ofthebacterium
isdetected
inanyof
thesampleun
its.
Histaminein
fisheryprod
ucts
from
fish
speciesassociated
with
ahigh
amou
ntof
histidine:
—satisfactory,
ifthefollo
wingrequ
irem
ents
arefulfilled:
1.themeanvalueob
served
is≤m
___________
(1)The
test
results
may
beused
also
fordemon
stratin
gtheeffectivenessof
thehazard
analysis
andcriticalcontrolpo
intprinciples
orgo
odhy
gieneprocedureof
theprocess.
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 18
2.amaxim
umof
c/nvalues
observed
arebetweenm
andM
3.no
values
observed
exceed
thelim
itof
M,
—un
satisfactory,
ifthemeanvalueob
served
exceedsm
ormorethan
c/nvalues
arebetweenm
andM
oron
eor
moreof
thevalues
observed
are>M.
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 19
Chap
ter2.
Process
hyg
ienecriteria
2.1Meatan
dprod
ucts
thereof
Foo
dcatego
ryMicro-organisms
Sam
plingplan
(1)
Lim
its(2)
Analytical
reference
metho
d(3)
Stage
where
thecriterion
applies
Actionin
case
ofun
satisfactory
results
nc
mM
2.1.1Carcases
ofcattle,
sheep,
goatsandho
rses
(4)
Aerob
iccolony
coun
t3,5log
cfu/cm
2
daily
mean
log
5,0log
cfu/cm
2
daily
mean
log
ISO
4833
Carcasesafterdressing
but
before
chilling
Improv
ements
inslaugh
ter
hygieneand
review
ofprocess
controls
Enterob
acteriaceae
1,5log
cfu/cm
2
daily
mean
log
2,5log
cfu/cm
2
daily
mean
log
ISO
2152
8-2
Carcasesafterdressing
but
before
chilling
Improv
ements
inslaugh
ter
hygieneand
review
ofprocess
controls
2.1.2Carcasesof
pigs
(4)
Aerob
iccolony
coun
t4,0log
cfu/cm
2
daily
mean
log
5,0log
cfu/cm
2
daily
mean
log
ISO
4833
Carcasesafterdressing
but
before
chilling
Improv
ements
inslaugh
ter
hygieneand
review
ofprocess
controls
Enterob
acteriaceae
2,0log
cfu/cm
2
daily
mean
log
3,0log
cfu/cm
2
daily
mean
log
ISO
2152
8-2
Carcasesafterdressing
but
before
chilling
Improv
ements
inslaugh
ter
hygieneand
review
ofprocess
controls
2.1.3Carcases
ofcattle,
sheep,
goatsandho
rses
Salmon
ella
50(5)
2(6)
Absence
inthearea
tested
percarcase
EN/ISO
6579
Carcasesafterdressing
but
before
chilling
Improv
ements
inslaugh
ter
hygiene,
review
ofprocess
controls
and
oforigin
ofanim
als
2.1.4Carcasesof
pigs
Salmon
ella
50(5)
5(6)
Absence
inthearea
tested
percarcase
EN/ISO
6579
Carcasesafterdressing
but
before
chilling
Improv
ements
inslaugh
ter
hygieneand
review
ofprocess
controls,origin
ofanim
alsand
ofthe
biosecurity
measuresin
thefarm
sof
origin
2.1.5Pou
ltry
carcases
ofbroilers
andturkeys
Salmon
ella
50(5)
7(6)
Absence
in25
gof
apo
oled
sampleof
neck
skin
EN/ISO
6579
Carcasesafterchilling
Improvem
ents
inslaughter
hygieneand
review
ofprocess
controls,origin
ofanim
alsand
biosecurity
measures
inthe
farm
sof
origin
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 20
Foo
dcatego
ryMicro-organisms
Sam
plingplan
(1)
Lim
its(2)
Analytical
reference
metho
d(3)
Stage
where
thecriterion
applies
Actionin
case
ofun
satisfactory
results
nc
mM
2.1.6Mincedmeat
Aerob
iccolony
coun
t(7 )
52
5×10
5
cfu/g
5×10
6
cfu/g
ISO
4833
End
ofthe
manufacturing
process
Improvem
ents
inproductio
nhy
giene
and
improv
ements
inselection
and/or
origin
ofraw
materials
E.coli(8)
52
50cfu/g
500cfu/g
ISO
1664
9-1
or2
End
ofthe
manufacturing
process
Improvem
ents
inproductio
nhy
giene
and
improv
ements
inselection
and/or
origin
ofraw
materials
2.1.7Mechanically
separatedmeat
(MSM)(9)
Aerob
iccolony
coun
t5
25×10
5
cfu/g
5×10
6
cfu/g
ISO
4833
End
ofthe
manufacturing
process
Improvem
ents
inproductio
nhy
giene
and
improv
ements
inselection
and/or
origin
ofraw
materials
E.coli(8)
52
50cfu/g
500cfu/g
ISO
1664
9-1
or2
End
ofthe
manufacturing
process
Improvem
ents
inproductio
nhy
giene
and
improv
ements
inselection
and/or
origin
ofraw
materials
2.1.8Meatpreparations
E.coli(8)
52
500cfu/g
orcm
2500
0cfu/
gor
cm2
ISO
1664
9-1
or2
End
ofthe
manufacturing
process
Improvem
ents
inproductio
nhy
giene
and
improv
ements
inselection
and/or
origin
ofraw
materials
(1)
n=nu
mberof
units
comprisingthesample;
c=nu
mberof
sampleun
itsgiving
values
betweenm
andM.
(2)
For
points
2.1.3-2.1.5m
=M.
(3)
The
mostrecent
edition
ofthestandard
shallbe
used.
(4)
The
limits
(mandM)shallapplyon
lyto
samples
takenby
thedestructivemetho
d.The
daily
meanlogshallbe
calculated
byfirsttaking
alogvalueof
each
individu
altestresultandthen
calculatingthemeanof
theselogvalues.
(5)
The
50samples
shallbe
derivedfrom
10consecutivesamplingsessions
inaccordance
with
thesamplingrulesandfrequencieslaid
downin
this
Regulation.
(6)
The
numberof
samples
where
thepresence
ofsalm
onella
isdetected.The
cvalueis
subjectto
review
inorderto
take
into
accoun
ttheprog
ress
madein
redu
cing
thesalm
onella
prevalence.Mem
berStatesor
region
shaving
low
salm
onella
prevalence
may
uselower
cvalues
even
before
thereview
.(7)
Thiscriterion
shallno
tapplyto
mincedmeatprod
uced
atretaillevelwhentheshelf-lifeof
theprod
uctis
less
then
24ho
urs.
(8)
E.coliis
used
here
asan
indicatorof
faecal
contam
ination.
(9)
These
criteriaapplyto
mechanically
separatedmeat(M
SM)prod
uced
with
thetechniqu
esreferred
toin
paragraph3of
Chapter
IIIof
Sectio
nV
ofAnn
exIIIto
Regulation(EC)No85
3/20
04of
theEurop
ean
Parliamentandof
theCou
ncil.
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 21
Interpretation
ofthetest
results
The
limits
givenreferto
each
sampleun
ittested,exclud
ingtestingof
carcases
where
thelim
itsreferto
pooled
samples.
The
test
results
demon
strate
themicrobiolog
ical
quality
oftheprocesstested.
Enterob
acteriaceaeandaerobiccolony
coun
tin
carcases
ofcattle,
sheep,
goats,
horses
andpigs:
—satisfactory,
ifthedaily
meanlogis
≤m,
—acceptable,ifthedaily
meanlogis
betweenm
andM,
—un
satisfactory,
ifthedaily
meanlogis
>M.
Salmon
ella
incarcases:
—satisfactory,
ifthepresence
ofSalmonella
isdetected
inamaxim
umof
c/nsamples,
—un
satisfactory,
ifthepresence
ofSa
lmon
ella
isdetected
inmorethan
c/nsamples.
After
each
samplingsession,
theresults
ofthelast
tensamplingsessions
shallbe
assessed
inorderto
obtain
thennu
mberof
samples.
E.coliandaerobiccolony
coun
tin
mincedmeat,meatpreparations
andmechanically
separatedmeat(M
SM):
—satisfactory,
ifallthevalues
observed
are≤m,
—acceptable,ifamaxim
umof
c/nvalues
arebetweenm
andM,andtherest
ofthevalues
observed
are≤m,
—un
satisfactory,
ifon
eor
moreof
thevalues
observed
are>M
ormorethan
c/nvalues
arebetweenm
andM.
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 22
2.2Milk
andda
iryprod
ucts
Foo
dcatego
ryMicro-organisms
Sam
plingplan
(1)
Lim
its(2)
Analytical
reference
metho
d(3)
Stage
where
thecriterion
applies
Actionin
case
ofun
satisfactory
results
nc
mM
▼M2
2.2.1
Pasteurised
milk
and
other
pasteurised
liquid
dairyprod
ucts(4)
Entero-bacter
iaceae
50
10cfu/ml
ISO
2152
8-2
End
ofthe
manufacturing
process
Check
onthe
efficiency
ofheat-treatmentand
preventio
nof
recontam
ination
aswellas
thequ
ality
ofraw
materials
▼M1
2.2.2
Cheeses
madefrom
milk
orwhey
that
has
undergon
eheat
treatm
ent
E.coli(5)
52
100cfu/g
100
0cfu/g
ISO
1664
9-1or
2At
the
time
during
the
manufacturing
process
when
the
E.coli
coun
tis
expected
tobe
high
est(
6 )
Improv
ements
inprod
uctio
nhy
gieneand
selection
ofraw
materials
2.2.3
Cheeses
made
from
raw
milk
Coagu
lase-positive
staphy
lococci
52
104cfu/g
105cfu/g
EN/ISO
6888
-2At
the
time
during
the
manufacturing
process
whenthenu
mberof
staphy
lococciis
expected
tobe
high
est
Improv
ements
inprod
uctio
nhy
gieneand
selection
ofraw
materials.If
values
>10
5cfu/
gare
detected,
the
cheese
batch
has
tobe
tested
for
staphy
lococcal
enterotoxins.
2.2.4
Cheeses
madefrom
milk
that
has
undergon
ea
lower
heat
treatm
ent
than
pasteurisatio
n(7)
and
ripened
cheeses
madefrom
milk
orwhey
that
has
undergon
epasteurisatio
nor
astrong
erheat
treatm
ent(
7 )
Coagu
lase-positive
staphy
lococci
52
100cfu/g
100
0cfu/g
EN/ISO
6888
-1or
2
2.2.5
Unripened
soft
cheeses
(fresh
cheeses)
made
from
milk
orwhey
that
has
undergon
epasteuri
satio
nor
astrong
erheat
treatm
ent(
7 )
Coagu
lase-positive
staphy
lococci
52
10cfu/g
100cfu/g
EN/ISO
6888
-1or
2End
ofthe
manufacturing
process
Improv
ements
inprod
uctio
nhy
giene.
Ifvalues
>10
5cfu/g
aredetected,thecheese
batch
hasto
betested
forstaphy
lo
coccal
enterotoxins.
2.2.6
Butter
and
cream
made
from
raw
milk
ormilk
that
has
undergon
ea
lower
heat
treatm
ent
than
pasteurisatio
n
E.coli(5)
52
10cfu/g
100cfu/g
ISO
1664
9-1or
2End
ofthe
manufacturing
process
Improv
ements
inprod
uctio
n
hygieneand
selection
ofraw
materials
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 23
Foo
dcatego
ryMicro-organisms
Sam
plingplan
(1)
Lim
its(2)
Analytical
reference
metho
d(3)
Stage
where
thecriterion
applies
Actionin
case
ofun
satisfactory
results
nc
mM
2.2.7
Milk
powderand
whey
powder(4)
Enterob
acteriaceae
50
10cfu/g
ISO
2152
8-2
End
ofthe
manufacturing
process
Check
onthe
efficiency
ofheat
treatm
entand
preventio
nof
recontam
ination
Coagu
lase-positive
staphy
lococci
52
10cfu/g
100cfu/g
EN/ISO
6888
-1or
2End
ofthe
manufacturing
process
Improv
ements
inprod
uctio
nhy
giene.
Ifvalues
>10
5cfu/g
aredetected,thebatchhasto
betested
for
staphy
lococcal
enterotoxins.
2.2.8
Ice
cream
(8)and
frozen
dairydesserts
Enterob
acteriaceae
52
10cfu/g
100cfu/g
ISO
2152
8-2
End
ofthe
manufacturing
process
Improv
ements
inprod
uctio
nhy
giene
2.2.9
Dried
infant
form
ulae
and
dried
dietary
food
sfor
specialmedical
purposes
intend
edfor
infants
below
sixmon
thsof
age
Enterob
acteriaceae
100
Absence
in10
gISO
2152
8-1
End
ofthe
manufacturing
process
Improv
ements
inprod
uctio
nhy
giene
tominim
ise
contam
ination(9)
2.2.10
Dried
follo
w-onform
ulae
Enterob
acteriaceae
50
Absence
in10
gISO
2152
8-1
End
ofthe
manufacturing
process
Improv
ements
inprod
uctio
nhy
giene
tominim
ise
contam
ination
2.2.11
Dried
infant
form
ulae
and
dried
dietary
food
sfor
specialmedical
purposes
intend
edfor
infants
below
sixmon
thsof
age
Presumptive
Bacillus
cereus
51
50cfu/g
500cfu/g
EN/ISO
7932
(10 )
End
ofthe
manufacturing
process
Improv
ements
inprod
uctio
nhy
giene.
Prevention
ofrecon
tamination.
Selectio
nof
raw
material.
(1)
n=nu
mberof
units
comprisingthesample;
c=nu
mberof
sampleun
itsgiving
values
betweenm
andM.
►M2
(2)For
points
2.2.1,
2.2.7,
2.2.9and2.2.10
m=M.◄
(3)
The
mostrecent
edition
ofthestandard
shallbe
used.
(4)
The
criterion
shallno
tapplyto
prod
ucts
intend
edforfurtherprocessing
inthefood
indu
stry.
(5)
E.coliis
used
here
asan
indicatorforthelevelof
hygiene.
(6)
For
cheeseswhich
areno
table
tosupp
ortthegrow
thof
E.coli,
theE.colicoun
tisusually
thehigh
estat
thebeginn
ingof
theripening
period
,andforcheeseswhich
areable
tosupp
ortthegrow
thof
E.coli,
itis
norm
ally
attheendof
theripening
period
.(7)
Excluding
cheeseswhere
themanufacturercandemon
strate,to
thesatisfactionof
thecompetent
authorities,that
theprod
uctdo
esno
tpo
searisk
ofstaphy
lococcal
enterotoxins.
(8)
Onlyicecreamscontaining
milk
ingredients.
(9)
ParalleltestingforEnterob
acteriaceaeandE.sakazakiishallbe
cond
ucted,
unless
acorrelationbetweenthesemicro-organismshasbeen
establishedat
anindividu
alplantlevel.IfEnterob
acteriaceaearedetected
inanyof
theprod
uctsamples
tested
insuch
aplant,thebatchhasto
betested
forE.sakazakii.Itshallbe
therespon
sibilityof
themanufacturerto
demon
strate
tothesatisfactionof
thecompetent
authority
whether
such
acorrelationexists
betweenEnterob
acteriaceaeandE.sakazakii.
(10 )
1mlof
inoculum
isplated
onaPetridish
of14
0mm
diam
eter
oron
threePetridishes
of90
mm
diam
eter.
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 24
Interpretation
ofthetest
results
The
limits
givenreferto
each
sampleun
ittested.
The
test
results
demon
strate
themicrobiolog
ical
quality
oftheprocesstested.
Enterob
acteriaceaein
driedinfant
form
ulae,drieddietaryfood
sforspecialmedical
purposes
intend
edforinfantsbelow
sixmon
thsof
ageanddriedfollo
w-onform
ulae:
—satisfactory,
ifallthevalues
observed
indicate
theabsenceof
thebacterium,
—un
satisfactory,
ifthepresence
ofthebacterium
isdetected
inanyof
thesampleun
its.
E.coli,Enterob
acteriaceae(other
food
catego
ries)andcoagulase-po
sitiv
estaphy
lococci:
—satisfactory,
ifallthevalues
observed
are≤m,
—acceptable,ifamaxim
umof
c/nvalues
arebetweenm
andM,andtherest
ofthevalues
observed
are≤m,
—un
satisfactory,
ifon
eor
moreof
thevalues
observed
are>M
ormorethan
c/nvalues
arebetweenm
andM.
PresumptiveBacillus
cereus
indriedinfant
form
ulae
anddrieddietaryfood
sforspecialmedical
purposes
intend
edforinfantsbelow
sixmon
thsof
age:
—satisfactory,
ifallthevalues
observed
are≤m,
—acceptable,ifamaxim
umof
c/nvalues
arebetweenm
andM,andtherest
ofthevalues
observed
are≤m,
—un
satisfactory,
ifon
eor
moreof
thevalues
observed
are>M
ormorethan
c/nvalues
arebetweenm
andM.
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 25
2.3Egg
prod
ucts
Foo
dcatego
ryMicro-organisms
Sam
plingplan
(1)
Lim
itsAnalytical
reference
metho
d(2)
Stage
where
thecriterion
applies
Actionin
case
ofun
satis
factoryresults
nc
mM
2.3.1Egg
prod
ucts
Enterob
acteriaceae
52
10cfu/gor
ml
100cfu/gor
ml
ISO
2152
8-2
End
ofthe
manufacturing
process
Checkson
theefficiency
oftheheat
treatm
entand
preventio
nof
recontam
inatio
n
(1)
n=nu
mberof
units
comprisingthesample;
c=nu
mberof
sampleun
itsgiving
values
betweenm
andM.
(2)
The
mostrecent
edition
ofthestandard
shallbe
used.
Interpretation
ofthetest
results
The
limits
givenreferto
each
sampleun
ittested.
The
test
results
demon
strate
themicrobiolog
ical
quality
oftheprocesstested.
Enterob
acteriaceaein
eggprod
ucts:
—satisfactory,
ifallthevalues
observed
are≤m,
—acceptable,ifamaxim
umof
c/nvalues
arebetweenm
andM,andtherest
ofthevalues
observed
are≤m,
—un
satisfactory,
ifon
eor
moreof
thevalues
observed
are>M
ormorethan
c/nvalues
arebetweenm
andM.
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 26
2.4Fishery
prod
ucts
Foo
dcatego
ryMicro-organisms
Sam
plingplan
(1)
Lim
itsAnalytical
reference
metho
d(2)
Stage
where
thecriterion
applies
Actionin
case
ofun
satisfactory
results
nc
mM
2.4.1Shelled
and
shucked
prod
ucts
ofcook
edcrus
taceans
and
molluscan
shellfish
E.coli
52
1/g
10/g
ISO
TS16
649-3
End
ofthe
manufacturing
process
Improv
ements
inprod
uctio
nhy
giene
Coagu
lase-positive
staphy
lococci
52
100cfu/g
100
0cfu/g
EN/ISO
6888
-1or
2End
ofthe
manufacturing
process
Improv
ements
inprod
uctio
nhy
giene
(1)
n=nu
mberof
units
comprisingthesample;
c=nu
mberof
sampleun
itsgiving
values
betweenm
andM.
(2)
The
mostrecent
edition
ofthestandard
shallbe
used.
Interpretation
ofthetest
results
The
limits
givenreferto
each
sampleun
ittested.
The
test
results
demon
strate
themicrobiolog
ical
quality
oftheprocesstested.
E.coliin
shelledandshuckedprod
ucts
ofcook
edcrustaceansandmolluscan
shellfish:
—satisfactory,
ifallthevalues
observed
are≤m,
—acceptable,ifamaxim
umof
c/nvalues
arebetweenm
andM,andtherest
ofthevalues
observed
are≤m,
—un
satisfactory,
ifon
eor
moreof
thevalues
observed
are>M
ormorethan
c/nvalues
arebetweenm
andM.
Coagu
lase-positive
staphy
lococciin
shelledandcook
edcrustaceansandmolluscan
shellfish:
—satisfactory,
ifallthevalues
observed
are≤m,
—acceptable,ifamaxim
umof
c/nvalues
arebetweenm
andM,andtherest
ofthevalues
observed
are≤m,
—un
satisfactory,
ifon
eor
moreof
thevalues
observed
are>M
ormorethan
c/nvalues
arebetweenm
andM.
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 27
2.5Vegetab
les,
fruits
andprod
ucts
thereof
Foo
dcatego
ryMicro-organisms
Sam
plingplan
(1)
Lim
itsAnalytical
reference
metho
d(2)
Stage
where
thecriterion
applies
Actionin
case
ofun
satisfactory
results
nc
mM
2.5.1Precut
fruit
and
vegetables
(ready
-to-eat)
E.coli
52
100cfu/g
100
0cfu/g
ISO
1664
9-1or
2Manufacturing
process
Improv
ements
inprod
uctio
nhy
giene,
selection
ofraw
materials
2.5.2Unp
asteurised
fruit
and
vegetablejuices
(ready
-to-eat)
E.coli
52
100cfu/g
100
0cfu/g
ISO
1664
9-1or
2Manufacturing
process
Improv
ements
inprod
uctio
nhy
giene,
selection
ofraw
materials
(1)
n=nu
mberof
units
comprisingthesample;
c=nu
mberof
sampleun
itsgiving
values
betweenm
andM.
(2)
The
mostrecent
edition
ofthestandard
shallbe
used.
Interpretation
ofthetest
results
The
limits
givenreferto
each
sampleun
ittested.
The
test
results
demon
strate
themicrobiolog
ical
quality
oftheprocesstested.
E.coliin
precut
fruitandvegetables
(ready
-to-eat)andin
unpasteurisedfruitandvegetablejuices
(ready
-to-eat):
—satisfactory,
ifallthevalues
observed
are≤m,
—acceptable,ifamaxim
umof
c/nvalues
arebetweenm
andM,andtherest
ofthevalues
observed
are≤m,
—un
satisfactory,
ifon
eor
moreof
thevalues
observed
are>M
ormorethan
c/nvalues
arebetweenm
andM.
▼M1
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 testsamples, the relevant standards of the ISO (International Organisation for Standardisation) and the guidelines of the Codex Alimentarius shall be used asreference methods.
3.2 Bacteriological sampling in slaughterhouses and at premises producingminced meat and meat preparations
S a m p l i n g r u l e s f o r c a r c a s e s o f c a t t l e , p i g s , s h e e p , g o a t sa n d h o r s e s
The destructive and non-destructive sampling methods, the selection of thesampling sites and the rules for storage and transport of samples are describedin standard ISO 17604.
Five carcases shall be sampled at random during each sampling session. Samplesites must be selected taking into account the slaughter technology used in eachplant.
When sampling for analyses of Enterobacteriaceae and aerobic colony counts,four sites of each carcase shall be sampled. Four tissue samples representing atotal 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 of100 cm2 (50 cm2 for small ruminant carcases) per sampling site.
When sampling for Salmonella analyses, an abrasive sponge sampling methodshall be used. Areas most likely to be contaminated shall be selected. The totalsampling area shall cover a minimum of 400 cm2.
When samples are taken from the different sampling sites on the carcase, theyshall be pooled before examination.
S a m p l i n g r u l e s f o r p o u l t r y c a r c a s e s
For the Salmonella analyses, a minimum of 15 carcases shall be sampled atrandom during each sampling session and after chilling. A piece of approximately 10 g from neck skin shall be obtained from each carcase. On eachoccasion the neck skin samples from three carcases shall be pooled before examination in order to form 5 × 25 g final samples.
G u i d e l i n e s f o r s a m p l i n g
More detailed guidelines on the sampling of carcases, in particular concerning thesampling sites, may be included in the guides to good practice referred to inArticle 7 of Regulation (EC) No 852/2004.
S a m p l i n g f r e q u e n c i e s f o r c a r c a s e s , m i n c e d m e a t , m e a tp r e p a r a t i o n s a n d m e c h a n i c a l l y s e p a r a t e d m e a t
The food business operators of slaughterhouses or establishments producingminced meat, meat preparations or mechanically separated meat shall takesamples for microbiological analysis at least once a week. The day ofsampling shall be changed each week to ensure that each day of the week iscovered.
As regards the sampling of minced meat and meat preparations for E. coli andaerobic colony count analyses and the sampling of carcases for Enterobacteriaceae and aerobic colony count analyses, the frequency may be reduced tofortnightly testing if satisfactory results are obtained for six consecutive weeks.
In the case of sampling for Salmonella analyses of minced meat, meatpreparations and carcases, the frequency may be reduced to fortnightly if satisfactory results have been obtained for 30 consecutive weeks. The salmonellasampling frequency may also be reduced if there is a national or regionalsalmonella control programme in place and if this programme includes testingthat replaces the sampling described in this paragraph. The sampling frequencymay be further reduced if the national or regional salmonella control programmedemonstrates that the salmonella prevalence is low in animals purchased by theslaughterhouse.
However, when justified on the basis of a risk analysis and consequentlyauthorised by the competent authority, small slaughterhouses and establishmentsproducing minced meat and meat preparations in small quantities may beexempted from these sampling frequencies.
▼M1
2005R2073— EN — 19.05.2010 — 002.001— 28
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 packagingsystem, 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 thegrowth and survival characteristics of the micro-organisms of concern.
When necessary on the basis of the abovementioned studies, the food businessoperator shall conduct additional studies, which may include:
— predictive mathematical modelling established for the food in question, usingcritical growth or survival factors for the micro-organisms of concern in theproduct,
— tests to investigate the ability of the appropriately inoculated micro-organismof concern to grow or survive in the product under different reasonablyforeseeable storage conditions,
— studies to evaluate the growth or survival of the micro-organisms of concernthat may be present in the product during the shelf-life under reasonablyforeseeable conditions of distribution, storage and use.
The above mentioned studies shall take into account the inherent variabilitylinked to the product, the micro-organisms in question and the processing andstorage conditions.
▼B
2005R2073— EN — 19.05.2010 — 002.001— 29
![For Amendment - Environmental Clearance [EC]](https://img.pdfslide.net/doc/110x75/631eff2b5ff22fc74506f4d5/for-amendment-environmental-clearance-ec.jpg)
