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I

(Acts whose publication is obligatory)

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 EuropeanCommunity,

Having regard to Regulation (EC) No 852/2004 of theEuropean Parliament and of the Council of 29 April 2004 onthe hygiene of foodstuffs (1), and in particular Articles 4(4)and 12 thereof,

Whereas:

(1) A high level of protection of public health is one of thefundamental objectives of food law, as laid down inRegulation (EC) No 178/2002 of the European Parlia-ment and of the Council of 28 January 2002 layingdown the general principles and requirements of foodlaw, establishing the European Food Safety Authority andlaying down procedures in matters of food safety (2).Microbiological hazards in foodstuffs form a majorsource of food-borne diseases in humans.

(2) Foodstuffs should not contain micro-organisms or theirtoxins or metabolites in quantities that present anunacceptable risk for human health.

(3) Regulation (EC) No 178/2002 lays down general foodsafety requirements, according to which food must notbe placed on the market if it is unsafe. Food businessoperators have an obligation to withdraw unsafe foodfrom the market. In order to contribute to the protectionof public health and to prevent differing interpretations,it is appropriate to establish harmonised safety criteria onthe acceptability of food, in particular as regards thepresence of certain pathogenic micro-organisms.

(4) Microbiological criteria also give guidance on theacceptability of foodstuffs and their manufacturing,handling and distribution processes. The use of micro-

biological criteria should form an integral part of theimplementation of HACCP-based procedures and otherhygiene control measures.

(5) The safety of foodstuffs is mainly ensured by a preventiveapproach, such as implementation of good hygienepractice and application of procedures based on hazardanalysis and critical control point (HACCP) principles.Microbiological criteria can be used in validation and

verification of HACCP procedures and other hygienecontrol measures. It is therefore appropriate to setmicrobiological criteria defining the acceptability of theprocesses, and also food safety microbiological criteriasetting a limit above which a foodstuff should beconsidered 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 microbiolo-gical criteria. This should include testing against thevalues set for the criteria through the taking of samples,the conduct of analyses and the implementation ofcorrective actions, in accordance with food law and theinstructions given by the competent authority. It istherefore appropriate to lay down implementing mea-sures concerning the analytical methods, including,where necessary, the measurement uncertainty, thesampling plan, the microbiological limits, the numberof analytical units that should comply with these limits.Furthermore, it is appropriate to lay down implementingmeasures concerning the foodstuff to which the criterionapplies, the points of the food chain where the criterion

applies, as well as the actions to be taken when thecriterion is not met. The measures to be taken by thefood business operators in order to ensure compliancewith criteria defining the acceptability of a process mayinclude, among other things, controls of raw materials,hygiene, temperature and shelf-life of the product.

22.12.2005 EN Official Journal of the European Union L 338/1

(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).

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(7) Regulation (EC) No 882/2004 of the European Parlia-ment and of the Council of 29 April 2004 on officialcontrols performed to ensure the verification ofcompliance with feed and food law, animal health andanimal welfare rules (1) requires the Member States toensure that official controls are carried out regularly, on arisk basis and with appropriate frequency. Those controlsshould take place at appropriate stages of the production,processing and distribution of food to ensure that thecriteria laid down in this Regulation are complied with byfood business operators.

(8) The Communication from the Commission on theCommunity Strategy for setting microbiological criteriafor foodstuffs (2) describes the strategy to lay down andrevise the criteria in Community legislation, as well as theprinciples for the development and application of the

criteria. This strategy should be applied when micro-biological criteria are laid down.

(9) The Scientific Committee on Veterinary Measures relatingto Public Health (SCVPH) issued an opinion on23 September 1999 on the evaluation of microbiologicalcriteria for food products of animal origin for humanconsumption. It highlighted the relevance of basingmicrobiological criteria on formal risk assessment andinternationally approved principles. The opinion recom-mends that microbiological criteria should be relevant

and effective in relation to consumer health protection.The SCVPH proposed, while awaiting formal riskassessments, certain revised criteria as interim measures.

(10) The SCVPH issued at the same time a separate opinionon Listeria monocytogenes. That opinion recommendedthat it be an objective to keep the concentration ofListeria monocytogenes in food below 100 cfu/g. TheScientific Committee on Food (SCF) agreed with theserecommendations in its opinion of 22 June 2000.

(11) The SCVPH adopted an opinion on Vibrio vulnificus andVibrio parahaemolyticus on 19 and 20 September 2001. Itconcluded that currently available scientific data do notsupport setting specific criteria for pathogenic V.vulnificus and parahaemolyticus in seafood. However, itrecommended that codes of practice should be estab-lished to ensure that good hygiene practice has beenapplied.

(12) The SCVPH issued an opinion on Norwalk-like viruses(NLVs, noroviruses) on 30-31 January 2002. In thatopinion it concluded that the conventional faecalindicators are unreliable for demonstrating the presenceor absence of NLVs and that the reliance on faecalbacterial indicator removal for determining shellfishpurification times is unsafe practice. It also recom-mended using E. coli rather than faecal coliforms toindicate faecal contamination in shellfish harvestingareas, when applying bacterial indicators.

(13) On 27 February 2002 the SCF adopted an opinion onspecifications for gelatine in terms of consumer health. Itconcluded that the microbiological criteria set inChapter 4 of Annex II to Council Directive 92/118/EECof 17 December 1992 laying down animal health and

public health requirements governing trade in andimports into the Community of products not subjectto the said requirements laid down in specific Commu-nity rules referred to in Annex A(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC (3) in terms of consumer health were excessive, andconsidered it sufficient to apply a mandatory micro-biological criterion for salmonella only.

(14) The SCVPH issued an opinion on verotoxigenic E. coli(VTEC) in foodstuffs on 21 and 22 January 2003. In itsopinion it concluded that applying an end-productmicrobiological standard for VTEC O157 is unlikely todeliver meaningful reductions in the associated risk forthe consumers. However, microbiological guidelinesaimed at reducing the faecal contamination along thefood chain can contribute to a reduction in public healthrisks, including VTEC. The SCVPH identified thefollowing food categories where VTEC represents ahazard to public health: raw or undercooked beef andpossibly meat from other ruminants, minced meat andfermented beef and products thereof, raw milk and rawmilk products, fresh produce, in particular sproutedseeds, and unpasteurised fruit and vegetable juices.

(15) On 26 and 27 March 2003 the SCVPH adopted anopinion on staphylococcal enterotoxins in milk products,particularly in cheeses. It recommended revising thecriteria for coagulase-positive staphylococci in cheeses, inraw milk intended for processing and in powdered milk.In addition, criteria for staphylococcal enterotoxinsshould be laid down for cheeses and powdered milk.

L 338/2 EN Official Journal of the European Union 22.12.2005


(2) SANCO/1252/2001 Discussion paper on strategy for settingmicrobiological criteria for foodstuffs in Community legisla-tion, p. 34.

(3) OJ L 62, 15.3.1993, p. 49. Directive as last amended byCommission Regulation (EC) No 445/2004 (OJ L 72,11.3.2004, p. 60).

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(16) The SCVPH adopted an opinion on salmonellae infoodstuffs on 14 and 15 April 2003. According to theopinion, food categories possibly posing a high risk topublic health include raw meat and some productsintended to be eaten raw, raw and undercooked productsof poultry meat, eggs and products containing raw eggs,unpasteurised milk and some products thereof. Sproutedseeds and unpasteurised fruit juices are also of concern. Itrecommended that the decision on the need formicrobiological criteria should be taken on the basis ofits ability to protect the consumers and its feasibility.

(17) The Scientific Panel on Biological Hazards (BIOHAZPanel) of the European Food Safety Authority (EFSA)issued an opinion on the microbiological risks in infantformulae and follow-on formulae on 9 September 2004.

It concluded that Salmonella and Enterobacter sakazakii arethe micro-organisms of greatest concern in infantformulae, formulae for special medical purposes andfollow-on formulae. The presence of these pathogensconstitutes a considerable risk if conditions afterreconstitution permit multiplication. Enterobacteriaceae,which are more often present, could be used as anindicator for risk. Monitoring and testing of Enterobac-teriaceae was recommended in both the manufacturingenvironment and the finished product by the EFSA.However, besides pathogenic species the family Enter-obacteriaceae includes also environmental species, whichoften appear in the food manufacturing environmentwithout posing any health hazard. Therefore, the family

Enterobacteriaceae can be used for routine monitoring,and if they are present testing of specific pathogens canbe started.

(18) International guidelines for microbiological criteria inrespect of many foodstuffs have not yet been established.However, the Commission has followed the CodexAlimentarius guideline Principles for the establishmentand application of microbiological criteria for foodsCAC/GL 21 1997 and in addition, the advice of theSCVPH and the SCF in laying down microbiologicalcriteria. Existing Codex specifications in respect of driedmilk products, foods for infants and children and thehistamine criterion for certain fish and fishery productshave been taken account. The adoption of Communitycriteria should benefit trade by providing harmonisedmicrobiological requirements for foodstuffs and repla-cing national criteria.

(19) The microbiological criteria set for certain categories offood of animal origin in Directives that were repealed byDirective 2004/41/EC of the European Parliament and ofthe Council of 21 April 2004 repealing certain Directivesconcerning food hygiene and health conditions for theproduction and placing on the market of certain

products of animal origin intended for human consump-tion and amending Council Directives 89/662/EEC and92/118/EEC and Council Decision 95/408/EC (1) shouldbe revised and certain new criteria set in the light of thescientific advice.

(20) The microbiological criteria laid down in CommissionDecision 93/51 EEC of 15 December 1992 on themicrobiological criteria applicable to the production ofcooked crustaceans and molluscan shellfish (2) areincorporated in this Regulation. It is therefore appro-priate to repeal that Decision. Since CommissionDecision 2001/471/EC of 8 June 2001 laying downrules for the regular checks on the general hygienecarried out by the operators in establishments accordingto Directive 64/433/EEC on health conditions for theproduction and marketing of fresh meat and Directive71/118/EEC on health problems affecting the productionand placing on the market of fresh poultrymeat (3) is

repealed with effect from the 1 January 2006, it isappropriate to incorporate microbiological criteria set forcarcases in this Regulation.

(21) The producer or manufacturer of a food product has todecide whether the product is ready to be consumed assuch, without the need to cook or otherwise process it inorder to ensure its safety and compliance with themicrobiological criteria. According to Article 3 ofDirective 2000/13/EC of the European Parliament andof the Council of 20 March 2000 on the approximationof the laws of the Member States relating to the labelling,presentation and advertising of foodstuffs (4), the

instructions for use of a foodstuff are compulsory onthe labelling when it would be impossible to makeappropriate use of the foodstuff in the absence of suchinstructions. Such instructions should be taken intoaccount by food business operators when decidingappropriate sampling frequencies for the testing againstmicrobiological criteria.

(22) Sampling of the production and processing environmentcan be a useful tool to identify and prevent the presenceof pathogenic micro-organisms in foodstuffs.

(23) Food business operators should decide themselves thenecessary sampling and testing frequencies as part oftheir procedures based on HACCP principles and otherhygiene control procedures. However, it may benecessary in certain cases to set harmonised samplingfrequencies at Community level, particularly in order toensure the same level of controls to be performedthroughout the Community.



(2) OJ L 13, 21.1.1993, p. 11.

(3) OJ L 165, 21.6.2001, p. 48. Decision as amended by Decision2004/379/EC (OJ L 144, 30.4.2004, p. 1).

(4) OJ L 109, 6.5.2000, p. 29. Directive as last amended byDirective 2003/89/EC (OJ L 308, 25.11.2003, p. 15).

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(24) Test results are dependent on the analytical method used,and therefore a given reference method should beassociated with each microbiological criterion. However,food business operators should have the possibility to useanalytical methods other than the reference methods, inparticular more rapid methods, as long as the use ofthese alternative methods provides equivalent results.Moreover, a sampling plan needs to be defined for eachcriterion in order to ensure harmonised implementation.It is nevertheless necessary to allow the use of othersampling and testing schemes, including the use ofalternative indicator organisms, on condition that theseschemes provide equivalent guarantees of food safety.

(25) Trends in test results should be analysed, as they are ableto reveal unwanted developments in the manufacturingprocess enabling the food business operator to takecorrective actions before the process is out of control.

(26) The microbiological criteria set in this Regulation shouldbe open to review and revised or supplemented, ifappropriate, in order to take into account developmentsin the field of food safety and food microbiology. Thisincludes progress in science, technology and methodol-ogy, changes in prevalence and contamination levels,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 analyticalmethods are developed sufficiently. There is a need fordevelopment of reliable methods for other microbialhazards too, e.g. Vibrio parahaemolyticus.

(28) It has been demonstrated that the implementation ofcontrol programmes can markedly contribute to areduction of the prevalence of salmonella in productionanimals and products thereof. The purpose of Regulation(EC) No 2160/2003 of the European Parliament and ofthe Council of 17 November 2003 on the control ofsalmonella and other specified food-borne zoonoticagents (1) is to ensure that proper and effective measuresare taken to control salmonella at relevant stages of thefood chain. Criteria for meat and products thereof shouldtake into account the expected improvement in thesalmonella situation at the level of primary production.

(29) For certain food safety criteria, it is appropriate to grantthe Member States a transitional derogation, enablingthem to comply with less stringent criteria but provided

that the foodstuffs would only be marketed on the

national market. The Member States should notify theCommission and other Member States where thistransitional derogation is used.

(30) The measures provided for in this Regulation are inaccordance 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 forcertain micro-organisms and the implementing rules to becomplied with by food business operators when implementing

the general and specific hygiene measures referred to inArticle 4 of Regulation (EC) No 852/2004. The competentauthority shall verify compliance with the rules and criterialaid down in this Regulation in accordance with Regulation(EC) No 882/2004, without prejudice to its right to undertakefurther sampling and analyses for the purpose of detecting andmeasuring other micro-organisms, their toxins or metabolites,either as a verification of processes, for food suspected ofbeing unsafe, or in the context of a risk analysis.

This Regulation shall apply without prejudice to other specificrules for the control of micro-organisms laid down inCommunity legislation and in particular the health standardsfor foodstuffs laid down in Regulation (EC) No 853/2004 of

the European Parliament and of the Council (2), the rules onparasites laid down under Regulation (EC) No 854/2004 ofthe European Parliament and of the Council (3) and themicrobiological criteria laid down under Council Directive 80/777/EEC (4).

Article 2

Definitions

The following definitions shall apply:

(a) micro-organisms means bacteria, viruses, yeasts,moulds, algae, parasitic protozoa, microscopic parasitichelminths, and their toxins and metabolites;

(b) microbiological criterion means a criterion defining theacceptability of a product, a batch of foodstuffs or aprocess, based on the absence, presence or number ofmicro-organisms, and/or on the quantity of their toxins/metabolites, per unit(s) of mass, volume, area or batch;


(1) OJ L 325, 12.12.2003, p. 1.


(3) OJ L 139, 30.4.2004, p. 206, corrected by OJ L 226,25.6.2004, p. 83.

(4) OJ L 229, 30.8.1980, p. 1.

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(c) food safety criterion means a criterion defining theacceptability of a product or a batch of foodstuffapplicable to products placed on the market;

(d) process hygiene criterion a criterion indicating theacceptable functioning of the production process. Such a

criterion is not applicable to products placed on themarket. It sets an indicative contamination value abovewhich corrective actions are required in order tomaintain the hygiene of the process in compliance withfood law;

(e) batch means a group or set of identifiable productsobtained from a given process under practically identicalcircumstances and produced in a given place within onedefined production period;

(f) shelf-life means either the period corresponding to the

period preceding theuse by

or the minimum durabilitydate, as defined respectively in Articles 9 and 10 of

Directive 2000/13/EC;

(g) ready-to-eat food means food intended by the produceror the manufacturer for direct human consumptionwithout the need for cooking or other processingeffective to eliminate or reduce to an acceptable levelmicro-organisms of concern;

(h) food intended for infants means food specificallyintended for infants, as defined in Commission Directive91/321/EEC (1);

(i) food intended for special medical purposes meansdietary food for special medical purposes, as defined inCommission Directive 1999/21/EC (2);

(j) sample means a set composed of one or several units ora portion of matter selected by different means in apopulation or in an important quantity of matter, whichis intended to provide information on a given character-istic of the studied population or matter and to provide abasis for a decision concerning the population or matterin question or concerning the process which has

produced it;

(k) representative sample means a sample in which thecharacteristics of the batch from which it is drawn aremaintained. This is in particular the case of a simplerandom sample where each of the items or increments ofthe batch has been given the same probability of enteringthe sample;

(l) compliance with microbiological criteria means obtain-ing satisfactory or acceptable results set in Annex I whentesting against the values set for the criteria through the

taking of samples, the conduct of analyses and theimplementation of corrective action, in accordance withfood law and the instructions given by the competentauthority.

Article 3

General requirements

1. Food business operators shall ensure that foodstuffscomply with the relevant microbiological criteria set out inAnnex I. To this end the food business operators at each stageof food production, processing and distribution, includingretail, shall take measures, as part of their procedures based onHACCP principles together with the implementation of goodhygiene practice, to ensure the following:

(a) that the supply, handling and processing of raw materialsand foodstuffs under their control are carried out in sucha way that the process hygiene criteria are met,

(b) that the food safety criteria applicable throughout theshelf-life of the products can be met under reasonablyforeseeable conditions of distribution, storage and use.

2. As necessary, the food business operators responsible forthe manufacture of the product shall conduct studies inaccordance with Annex II in order to investigate compliance

with the criteria throughout the shelf-life. In particular, thisapplies to ready-to-eat foods that are able to support thegrowth of Listeria monocytogenes and that may pose a Listeriamonocytogenes risk for public health.

Food businesses may collaborate in conducting those studies.

Guidelines for conducting those studies may be included inthe guides to good practice referred to in Article 7 ofRegulation (EC) No 852/2004.

Article 4

Testing against criteria

1. Food business operators shall perform testing as appro-priate against the microbiological criteria set out in Annex I,when they are validating or verifying the correct functioningof their procedures based on HACCP principles and goodhygiene practice.

2. Food business operators shall decide the appropriatesampling frequencies, except where Annex I provides forspecific sampling frequencies, in which case the samplingfrequency shall be at least that provided for in Annex I. Foodbusiness operators shall make this decision in the context oftheir procedures based on HACCP principles and good


(1) OJ L 175, 4.7.1991, p. 35.

(2) OJ L 91, 7.4.1999, p. 29.

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hygiene practice, taking into account the instructions for useof the foodstuff.

The frequency of sampling may be adapted to the nature andsize 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 andmethods in Annex I shall be applied as reference methods.

2. Samples shall be taken from processing areas andequipment used in food production, when such sampling isnecessary for ensuring that the criteria are met. In thatsampling the ISO standard 18593 shall be used as a referencemethod.

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 Listeriamonocytogenes as part of their sampling scheme.

Food business operators manufacturing dried infant formulae

or dried foods for special medical purposes intended forinfants below six months which pose an Enterobacter sakazakiirisk shall monitor the processing areas and equipment forEnterobacteriaceae as part of their sampling scheme.

3. The number of sample units of the sampling plans set outin Annex I may be reduced if the food business operator candemonstrate by historical documentation that he has effectiveHACCP-based procedures.

4. If the aim of the testing is to specifically assess theacceptability of a certain batch of foodstuffs or a process, the

sampling plans set out in Annex I shall be respected as aminimum.

5. Food business operators may use other sampling andtesting procedures, if they can demonstrate to the satisfactionof the competent authority that these procedures provide atleast equivalent guarantees. Those procedures may include useof alternative sampling sites and use of trend analyses.

Testing against alternative micro-organisms and relatedmicrobiological limits as well as testing of analytes other

than microbiological ones shall be allowed only for processhygiene criteria.

The use of alternative analytical methods is acceptable whenthe methods are validated against the reference method in

Annex I and if a proprietary method, certified by a third partyin accordance with the protocol set out in EN/ISO standard 16140 or other internationally accepted similarprotocols, is used.

If the food business operator wishes to use analytical methodsother than those validated and certified as described inparagraph 3 the methods shall be validated according tointernationally accepted protocols and their use authorised bythe competent authority.

Article 6

Labelling requirements

1. When the requirements for Salmonella in minced meat,meat preparations and meat products intended to be eatencooked of all species set down in Annex I are fulfilled, thebatches of those products placed on the market must beclearly labelled by the manufacturer in order to inform theconsumer of the need for thorough cooking prior toconsumption.

2. As from 1 January 2010 labelling as referred to inparagraph 1 in respect of minced meat, meat preparations andmeat products made from poultrymeat will no longer berequired.

Article 7

Unsatisfactory results

1. When the results of testing against the criteria set out inAnnex I are unsatisfactory, the food business operators shalltake the measures laid down in paragraphs 2 to 4 of thisArticle together with other corrective actions defined in theirHACCP-based procedures and other actions necessary toprotect the health of consumers.

In addition, they shall take measures to find the cause of theunsatisfactory results in order to prevent the recurrence of theunacceptable microbiological contamination. Those measuresmay include modifications to the HACCP-based procedures orother food hygiene control measures in place.

2. When testing against food safety criteria set out inChapter 1 of Annex I provides unsatisfactory results, theproduct or batch of foodstuffs shall be withdrawn or recalledin accordance with Article 19 of Regulation (EC) No 178/

2002. However, products placed on the market, which are notyet at retail level and which do not fulfil the food safetycriteria, may be submitted to further processing by atreatment eliminating the hazard in question. This treatmentmay only be carried out by food business operators other thanthose at retail level.


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The food business operator may use the batch for purposesother than those for which it was originally intended,provided that this use does not pose a risk for public oranimal health and provided that this use has been decidedwithin the procedures based on HACCP principles and goodhygiene practice and authorised by the competent authority.

3. A batch of mechanically separated meat (MSM) producedwith the techniques referred to in Chapter III, paragraph 3, inSection V of Annex III to Regulation (EC) No 853/2004, withunsatisfactory 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 accor-dance with Regulation (EC) No 853/2004.

4. In the event of unsatisfactory results as regards processhygiene criteria the actions laid down in Annex I, Chapter 2shall be taken.

Article 8

Transitional derogation

1. A transitional derogation is granted until 31 December2009 at the latest pursuant to Article 12 of Regulation (EC)No 852/2004 as regards compliance with the value set inAnnex I to this Regulation for Salmonella in minced meat,meat preparations and meat products intended to be eatencooked placed on the national market of a Member State.

2. The Member States using this possibility shall notify theCommission and other Member States thereof. The MemberState shall:

(a) guarantee that the appropriate means, including labellingand a special mark, which cannot be confused with theidentification mark provided for in Annex II, Section I toRegulation (EC) No 853/2004, are in place to ensure thatthe derogation applies only to the products concernedwhen placed on the domestic market, and that productsdispatched for intra-Community trade comply with thecriteria laid down in Annex I;

(b) provide that the products to which such transitionalderogation applies shall be clearly labelled that they mustbe thoroughly cooked prior to consumption;

(c) undertake that when testing against the Salmonellacriterion pursuant to Article 4, and for the result to beacceptable as regards such transitional derogation, no

more than one out of five sample units shall be found tobe positive.

Article 9

Analyses of trends

Food business operators shall analyse trends in the test results.When they observe a trend towards unsatisfactory results, theyshall take appropriate actions without undue delay to remedythe situation in order to prevent the occurrence ofmicrobiological risks.

Article 10

Review

This Regulation shall be reviewed taking into account progressin science, technology and methodology, emerging pathogenicmicro-organisms in foodstuffs, and information from riskassessments. In particular, the criteria and conditionsconcerning the presence of salmonella in carcases of cattle,sheep, goats, horses, pigs and poultry shall be revised in thelight 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 dayfollowing its publication in the Official Journal of the EuropeanUnion.

It shall apply from 1 January 2006.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 November 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission


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ANNEX I

Microbiological criteria for foodstuffs

Chapter 1. Food safety criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Chapter 2. Process hygiene criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2.1. Meat and products thereof . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2.2. Milk and dairy products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

2.3. Egg products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

2.4. Fishery products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

2.5. Vegetables, fruits and products thereof . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Chapter 3. Rules for sampling and preparation of test samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

3.1. General rules for sampling and preparation of test samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

3.2. Bacteriological sampling in slaughterhouses and at premises producing minced meat and meatp r e p a r a t i o n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24


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Chapter1.Fo

odsafetycriteria

Foodcategory

Micro-organisms/their

toxin

s,metabolites

Sampling-plan(1)

Limits(2)

Analyticalreference

method(3)

Stagewherethecriterionapplies

n

c

m

M

1.1.

Ready-to-e

atfoodsintendedforinfants

andready-to-eatfoodsforspecialmedical

purposes(

4)

Listeria

monocytogenes

10

0

Absencein25g

EN/ISO

11290-1

Productsplacedonthemarket

duringtheirsh

elf-life

1.2.Ready-to-e

atfoodsabletosupportthe

growthof

L.monocytogenes,otherthan

thoseintendedforinfantsandforspecial

medicalpurposes

Listeriamonocytogenes

5

0

100cfu/g(5)

EN/ISO

11290-2(6)


duringtheirsh

elf-life

5

0

Absencein25g(7)

EN/ISO

11290-1

Beforethefoodhasleftthe

immediatecon

trolofthefood

businessoperator,whohaspro-

ducedit

1.3.Ready-to-e

atfoodsunabletosupportthe

growthof

L.monocytogenes,otherthan

thoseintendedforinfantsandforspecial

medicalpurposes(4)(8)

Listeria

monocytogenes

5

0

100cfu/g

EN/ISO

11290-2(6)


duringtheirsh

elf-life

1.4.Mincedmeatandmeatpreparations

intendedtobeeatenraw

Salmone

lla

5

0

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life

1.5.Mincedmeatandmeatpreparationsmade

from

poultrymeatintendedtobeeaten

cooked

Salmone

lla

5

0

From

1.1.2006

Absencein10g

From

1.1.2010

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life

1.6.Mincedmeatandmeatpreparationsmade

from

otherspeciesthanpoultryintended

tobeeatencooked

Salmone

lla

5

0

Absencein10g

EN/ISO

6579


duringtheirsh

elf-life

1.7.

Mechanica

llyseparatedmeat(MSM)(9)

Salmon

ella

5

0

Absencein10g

EN/ISO

6579


duringtheirsh

elf-life

1.8.Meatprod

uctsintendedtobeeatenraw,

excluding

productswherethemanufac-

turingpro

cessorthecompositionofthe

productw

illeliminatethesalmonellarisk

Salmone

lla

5

0

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life


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Foodcategory


toxin

s,metabolites

Sampling-plan(1)

Limits(2)

Analyticalreference

method(3)


n

c

m

M

1.9.Meatprod

uctsmadefrom

poultrymeat

intendedtobeeatencooked

Salmone

lla

5

0

From

1.1.2006

Absencein10g

From

1.1.2010

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life

1.10.Gelatineandcollagen

Salmone

lla

5

0

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life

1.11.Cheeses,butterandcream

madefrom

raw

milkorm

ilkthathasundergonealower

heattreatm

entthanpasteurisation(1

0)

Salmon

ella

5

0

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life

1.12.Milkpowd

erandwheypowder(1

0)

Salmon

ella

5

0

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life

1.13.Icecream

(11),excludingproductswhere

themanuf

acturingprocessorthecom-

positiono

ftheproductwilleliminatethe

salmonella

risk

Salmone

lla

5

0

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life

1.14.Eggprodu

cts,excludingproductswhere

themanuf

acturingprocessorthecom-

positiono

ftheproductwilleliminatethe

salmonella

risk

Salmone

lla

5

0

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life

1.15.Ready-to-e

atfoodscontainingraw

egg,

excluding

productswherethemanufac-

turingpro

cessorthecompositionofthe

productw

illeliminatethesalmonellarisk

Salmone

lla

5

0

Absencein25gorml

EN/ISO

6579


duringtheirsh

elf-life

1.16.Cookedcr

ustaceansandmolluscanshell-

fish

Salmone

lla

5

0

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life

1.17.Livebivalv

emolluscsandliveechino-

derms,tun

icatesandgastropods

Salmone

lla

5

0

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life


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Foodcategory


toxin

s,metabolites

Sampling-plan(1)

Limits(2)

Analyticalreference

method(3)


n

c

m

M

1.18.Sproutedseeds(ready-to-eat)(1

2)

Salmon

ella

5

0

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life

1.19.Pre-cutfru

itandvegetables(ready-to-eat)

Salmone

lla

5

0

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life

1.20.Unpasteur

isedfruitandvegetablejuices

(ready-to-eat)

Salmone

lla

5

0

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life

1.21.Cheeses,m

ilkpowderandwheypowder,

asreferred

tointhecoagulase-positive

staphyloco

ccicriteriainChapter2.2of

thisAnnex

Staphylococcalentero-

toxins

5

0

Notdetectedin25g

Europeanscreening

methodoftheCRLfor

Milk(1

3)


duringtheirsh

elf-life

1.22.Driedinfa

ntformulaeanddrieddietary

foodsforspecialmedicalpurposes

intendedf

orinfantsbelow

sixmonthsof

age,asref

erredtointheEnterobacter-

iaceaecriterioninChapter2.2ofthis

Annex

Salmone

lla

30

0

Absencein25g

EN/ISO

6579


duringtheirsh

elf-life

1.23.Driedinfa


foodsforspecialmedicalpurposes

intendedf

orinfantsbelow

sixmonthsof

age,asref

erredtointheEnterobacter-

iaceaecriterioninChapter2.2ofthis

Annex

Enteroba

ctersakazakii

30

0

Absencein10g

ISO/DTS22964


duringtheirsh

elf-life

1.24.Livebivalv

emolluscsandliveechino-

derms,tun

icatesandgastropods

E.coli(

14)

1(1

5)

0

230MPN/100goffleshand

intra-valvularliquid

ISO

TS16649-3


duringtheirsh

elf-life

1.25.Fisherypr

oductsfrom

fishspeciesasso-

ciatedwithahighamountofhistidine(1

6)

Histamine

9 (17)

2

100

mg/kg

200

mg/kg

HPLC(1

8)


duringtheirsh

elf-life


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Interpretation

ofthetestresults

Thelimitsgiven

refertoeachsampleunittested,excludin

glivebivalvemolluscsandliveechinoderms,tunicatesandgastropodsinrelationt

otestingE.coli,wherethelimitreferstoapooledsample.

Thetestresults

demonstratethemicrobiologicalqualityo

fthebatchtested(1).

L.monocytogenes

inready-to-eatfoodsintendedforinfants

andforspecialmedicalpurposes:

satisfactory,ifallthevaluesobservedindicatetheab

senceofthebacterium,

unsatisfact

ory,ifthepresenceofthebacterium

isde

tectedinanyofthesampleunits.

L.monocytogenes

inready-to-eatfoodsabletosupporttheg

rowthofL.monocytogenesbeforethefoodh

aslefttheimmediatecontroloftheproducingfoodbusinessoperatorwhenheisnotabletodemonstrate

thattheproductwillnotexceedthelimitof100cfu/gth

roughouttheshelf-life:



unsatisfact


isde


L.monocytogenes

inotherready-to-eatfoodsandE.coliin

livebivalvemolluscs:

satisfactory,ifallthevaluesobservedare

thelimit,

unsatisfact

ory,ifanyofthevaluesare>thelimit.

Salmonellaindifferentfoodcategories:



unsatisfact


isde



(1)

Thetestres

ultscanbeusedalsofordemonstratingtheeffectivenessoftheHACCPorgoodhygieneproc

edureoftheprocess.

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Staphylococcalenterotoxinsindairyproducts:

satisfactory,ifinallthesampleunitstheenterotoxin

sarenotdetected,

unsatisfact

ory,iftheenterotoxinsaredetectedinanyofthesampleunits.

Enterobactersakazakiiindriedinfantformulaeanddrieddietaryfoodsforspecialmedicalpurposesi

ntendedforinfantsbelow

6monthsofag

e:



unsatisfact


isde


Histamineinfis

heryproductsfrom

fishspeciesassociated

withahighamountofhistidine:

satisfactory,ifthefollowingrequirementsarefulfille

d:

1.

them

eanvalueobservedis

m

2.

ama

ximum

ofc/nvaluesobservedarebetwee

nm

andM

3.

novaluesobservedexceedthelimitofM,

unsatisfact

ory,ifthemeanvalueobservedexceedsm

ormorethanc/nvaluesarebetweenm

andM

oroneormoreofthevaluesobservedare>M.


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Chapter2.Proc

esshygienecriteria

2.1.

Meatandproductsthereof

Foodcategory

Micro-organisms

Samplingplan(1)

Limits(2)

Analyticalrefe

rence

method(

3

)

Stagewherethe

criterionapplies

Actionin

caseofunsatisfactory

results

n

c

m

M

2.1.1.Carcaseso

fcattle,sheep,goatsand

horses(4)

Aerobicc

olony

count

3,5log

cfu/cm

2

dailymean

log

5,0log

cfu/cm

2

dailymean

log

ISO

4833

Carcasesafterdres-

singbutbeforechil-

ling

Improvementsinslaughter

hygieneandreview

ofpro-

cesscontrols

Enterobacteriaceae

1,5log

cfu/cm

2

dailymean

log

2,5log

cfu/cm

2

dailymean

log

ISO

21528

-2

Carcasesafterdres-

singbutbeforechil-

ling


hygieneandreview

ofpro-

cesscontrols

2.1.2.Carcasesofpigs(4)

Aerobicc

olony

count

4,0log

cfu/cm

2

dailymean

log

5,0log

cfu/cm

2

dailymean

log

ISO

4833

Carcasesafterdres-

singbutbeforechil-

ling


hygieneandreview

ofpro-

cesscontrols

Enterobacteriaceae

2,0log

cfu/cm

2

dailymean

log

3,0log

cfu/cm

2

dailymean

log

ISO

21528

-2

Carcasesafterdres-

singbutbeforechil-

ling


hygieneandreview

ofpro-

cesscontrols

2.1.3.Carcasesofcattle,sheep,goatsand

horses

Salmonella

50(5)

2(6)

Absenceinthearea

testedpercarcase

EN/ISO

65

79

Carcasesafterdres-

singbutbeforechil-

ling


hygiene,

review

ofprocess

controls

andoforiginof

animals

2.1.4.Carcasesofpig

Salmonella

50(5)

5(6)

Absenceinthearea

testedpercarcase

EN/ISO

65

79

Carcasesafterdres-

singbutbeforechil-

ling


hygieneandreview

ofpro-

cesscontrols,originofani-

malsand

ofthebiosecurity

measuresinthefarmsof

origin

2.1.5.Poultryca

rcasesofbroilersandturkeys

Salmonella

50(5)

7(6)

Absencein25gofa

pooledsampleofneck

skin

EN/ISO

65

79

Carcasesafterchilling


hygieneandreview

ofpro-

cesscontrols,originofani-

malsand

biosecurity

measuresinthefarmsof

origin


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Foodcategory

Micro-organisms

Samplingplan(1)

Limits(2)

Analyticalrefe

rence

method(

3

)

Stagewherethe

criterionapplies

Actionin


results

n

c

m

M

2.1.6.Mincedm

eat

Aerobicc

olony

count(7)

5

2

5x10

5

cfu/g

5x10

6

cfu/g

ISO

4833

Endofthemanufac-

turingprocess

Improvementsinproduction

hygieneandimprovements

inselectionand/ororiginof

raw

materials

E.coli(8)

5

2

50cfu/g

500cfu/g

ISO

16649-1

or2

Endofthemanufac-

turingprocess




raw

materials

2.1.7.Mechanicallyseparatedmeat(MSM)(9)

Aerobicc

olony

count

5

2

5x10

5

cfu/g

5x10

6

cfu/g

ISO

4833

Endofthemanufac-

turingprocess




raw

materials

E.coli(8)

5

2

50cfu/g

500cfu/g

ISO

16649-1

or2

Endofthemanufac-

turingprocess




raw

materials

2.1.8.Meatprep

arations

E.coli(8)

5

2

500cfu/g

orcm

2

5000cfu/

gorcm

2

ISO

16649-1

or2

Endofthemanufac-

turingprocess




raw

materials

(1)

n=numberofunitscomprisingthesample;c=numberof

sampleunitsgivingvaluesbetweenm

andM.

(2)

Forpoints2.1.3

2.1.5m=M.

(3)

Themostrecenteditionofthestandardshallbeused.

(4)

Thelimits(m

andM)applyonlytosamplestakenbythede

structivemethod.Thedailymeanlogiscalculatedbyfirsttakingalogvalueofeachindividu

altestresultandthencalculatingthemeanof

theselogvalues.

(5)

The50samp

lesarederivedfrom

10consecutivesamplings

essionsinaccordancewiththesamplingrulesandfrequencieslaiddowninthisRegulation.

(6)

Thenumberofsampleswherethepresenceofsalmonellaisdetected.Thecvalueissubjecttoreviewinordertotakeintoaccounttheprogressmadeinred

ucingthesalmonellaprevalence.MemberStatesorregionshavinglow

salmonellapr

evalencemayuselowercvaluesevenbeforeth

ereview.

(7)

Thiscriterion

doesnotapplytomincedmeatproducedatretaillevelwhentheshelf-lifeoftheproductislessthen24hours.

(8)

E.coliisused

hereasanindicatoroffaecalcontamination.

(9)

Thesecriteria

applytomechanicallyseparatedmeat(MSM)producedwiththetechniquesreferredtoinChap

terIII,paragraph3,insectionVofAnnexIIIofRegulation(EC)No853/2004oftheEuropeanParliamentandofthe

Councilof29

April2004layingdownspecifichygienerule

sforfoodofanimalorigin.


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Interpretation

ofthetestresults

Thelimitsgiven

refertoeachsampleunittested,excludin

gtestingofcarcaseswherethelimitsrefe

rtopooledsamples.

Thetestresults


ftheprocesstested.

Enterobacteriace

aeandaerobiccolonycountincarcaseso

fcattle,sheep,goats,horsesandpigs:

satisfactory,ifthedailymeanlogisM.

Salmonellaincarcases:

satisfactory,ifthepresenceofSalmonellaisdetected

inamaximum

ofc/nsamples,

unsatisfact

ory,ifthepresenceofSalmonellaisdetect

edinmorethanc/nsamples.

Aftereachsamp

lingsession,theresultsofthelasttensam

plingsessionsareassessedinordertoobtainthennumberofsamples.

E.coliandaerob

iccolonycountinmincedmeat,meatpr

eparationsandmechanicallyseparatedme

at(MSM):

satisfactory,ifallthevaluesobservedare10

5cfu/g

aredetec

ted,thecheesebatch

hastobetestedforstaphy-

lococcal

enterotoxins.

2.2.6.Butterandcream

madefrom

rawmilk

ormilkthathasundergonealower

heattreat

mentthanpasteurisation

E.coli(5)

5

2

10cfu/g

100cfu/g

ISO

16649-1

or2

Endofthemanufac-

turingprocess


hygieneandselectionofraw

materials


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Foodcategory

Micro-organisms

Samplingplan(1)

Limits(2)

Analyticalrefe

rence

method(

3

)

Stagewherethe

criterionapplies

Actionin


results

n

c

m

M

2.2.7.Milkpowderandwheypowder(4)

Enterobacteriaceae

5

0

10cfu/g

ISO

21528

-1

Endofthemanufac-

turingprocess

Checkontheefficiencyof

heattrea

tmentandpreven-

tionofr

econtamination

Coagulase-positive

staphyloc

occi

5

2

10cfu/g

100cfu/g

EN/ISO

6888

-1or

2

Endofthemanufac-

turingprocess


hygiene.

Ifvalues>10

5cfu/g

aredetec

ted,thebatchhasto

betested

forstaphylococcal

enterotoxins.

2.2.8.Icecream

(8)andfrozendairydesserts

Enterobacteriaceae

5

2

10cfu/g

100cfu/g

ISO

21528

-2

Endofthemanufac-

turingprocess


hygiene

2.2.9.Driedinfa


foodsfor

specialmedicalpurposes

intended

forinfantsbelow

sixmonths

ofage

Enterobacteriaceae

10

0

Absencein10g

ISO

21528

-1

Endofthemanufac-

turingprocess


hygienetominimisecon-

tamination.IfEnterobacter-

iaceaear

edetectedinanyof

thesamp

leunits,thebatch

hastobetestedforE.

sakazakii

andSalmonella

(1)

n=numberofunitscomprisingthesample;c=numberof

sampleunitsgivingvaluesbetweenm

andM.

(2)

Forpoint2.2

.7m=M.

(3)

Themostrecenteditionofthestandardshallbeused.

(4)

Thecriterion

doesnotapplytoproductsintendedforfurtherprocessinginthefoodindustry.

(5)

E.coliisused

hereasanindicatorforthelevelofhygiene.

(6)

Forcheesesw

hicharenotabletosupportthegrowthofE.coli,theE.colicountisusuallythehighestatthebeg

inningoftheripeningperiod,andforcheesesw

hichareabletosupportthegrowthofE.coli,itisnormallyattheendof

theripeningperiod.

(7)

Excludingcheeseswherethemanufacturercandemonstrate,

tothesatisfactionofthecompetentauthorities,thattheproductdoesnotposeariskofstap

hylococcalenterotoxins.

(8)

Onlyicecreamscontainingmilkingredients.


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Interpretation

ofthetestresults

Thelimitsgiven

refertoeachsampleunittested.

Thetestresults


ftheprocesstested.

Enterobacteriace

aeindriedinfantformulaeanddrieddietaryfoodsforspecialmedicalpurposesintendedforinfantsbelow

sixmonthsofag

e:



unsatisfact


isde

tectedinanyofthesampleunits

E.coli,enterobacteriaceae(otherfoodcategories)andcoag

ulase-positivestaphylococci:

satisfactory,ifallthevaluesobservedare

Reg2073_2005(1) OK

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Transcript of Reg2073_2005(1) OK