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transcript
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 andverification 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 criterionapplies, 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.
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(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).
(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 thecriteria. 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 relevantand 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 andpublic 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.
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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 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).
(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 familyEnterobacteriaceae 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) isrepealed 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), theinstructions 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.
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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).
(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 providedthat 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 Committeeon 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 implementingthe 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 ofthe 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;
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(1) OJ L 325, 12.12.2003, p. 1.
(2) OJ L 139, 30.4.2004, p. 55, corrected by OJ L 226, 25.6.2004,p. 22.
(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.
(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 acriterion 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 theperiod preceding the ‘use by’ or the minimum durabilitydate, as defined respectively in Articles 9 and 10 ofDirective 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 hasproduced 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 compliancewith 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
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(1) OJ L 175, 4.7.1991, p. 35.(2) OJ L 91, 7.4.1999, p. 29.
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 offoodstuffs 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 formulaeor 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, thesampling 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 otherthan 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, nomore 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 meatpreparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
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Chapter
1.Fo
odsafety
crite
ria
Food
category
Micro-organisms/their
toxins,m
etabolites
Sampling-plan
(1)
Limits
(2)
Analyticalreference
metho
d(3)
Stagewhere
thecriterio
napplies
nc
mM
1.1.
Ready-to-eat
foodsintend
edforinfants
andready-to-eat
foodsforspecialm
edical
purposes
(4)
Listeria
monocytogenes
100
Absence
in25
gEN
/ISO
1129
0-1
Productsplaced
onthemarket
during
theirshelf-life
1.2.
Ready-to-eat
foodsableto
supp
ortthe
grow
thof
L.monocytogenes,o
ther
than
thoseintend
edforinfantsandforspecial
medicalpu
rposes
Listeria
monocytogenes
50
100cfu/g(5)
EN/IS
O1129
0-2(6)
Productsplaced
onthemarket
during
theirshelf-life
50
Absence
in25
g(7)
EN/IS
O1129
0-1
Before
thefood
hasleftthe
immediate
controlo
fthefood
business
operator,w
hohaspro-
ducedit
1.3.
Ready-to-eat
foodsun
ableto
supp
ortthe
grow
thof
L.monocytogenes,o
ther
than
thoseintend
edforinfantsandforspecial
medicalpu
rposes
(4)(
8 )
Listeria
monocytogenes
50
100cfu/g
EN/IS
O1129
0-2(6)
Productsplaced
onthemarket
during
theirshelf-life
1.4.
Mincedmeatandmeatpreparations
intend
edto
beeatenraw
Salmonella
50
Absence
in25
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
1.5.
Mincedmeatand
meatp
reparatio
nsmade
from
poultrymeatintend
edto
beeaten
cooked
Salmonella
50
From
1.1.20
06Absence
in10
gFrom
1.1.20
10Absence
in25
g
EN/IS
O65
79Productsplaced
onthemarket
during
theirshelf-life
1.6.
Mincedmeatand
meatp
reparatio
nsmade
from
otherspeciesthan
poultryintend
edto
beeatencooked
Salmonella
50
Absence
in10
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
1.7.
Mechanically
separatedmeat(M
SM)(
9 )Salmonella
50
Absence
in10
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
1.8.
Meatproductsintend
edto
beeatenraw,
excludingproductswhere
themanufac-
turing
processor
thecompo
sitio
nof
the
productwill
elim
inatethesalm
onellarisk
Salmonella
50
Absence
in25
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
22.12.2005 EN Official Journal of the European Union L 338/9
Food
category
Micro-organisms/their
toxins,m
etabolites
Sampling-plan
(1)
Limits
(2)
Analyticalreference
metho
d(3)
Stagewhere
thecriterio
napplies
nc
mM
1.9.
Meatproductsmadefrom
poultrymeat
intend
edto
beeatencooked
Salmonella
50
From
1.1.20
06Absence
in10
gFrom
1.1.20
10Absence
in25
g
EN/IS
O65
79Productsplaced
onthemarket
during
theirshelf-life
1.10.G
elatineandcollagen
Salmonella
50
Absence
in25
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
1.11.Ch
eeses,butterandcream
madefrom
raw
milk
ormilk
that
hasun
dergon
ealower
heat
treatm
entthan
pasteurisatio
n(10)
Salmonella
50
Absence
in25
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
1.12
.Milk
powderandwheypowder(
10)
Salmonella
50
Absence
in25
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
1.13.Ice
cream
(11),excludingproductswhere
themanufacturing
processor
thecom-
positio
nof
theproductwill
elim
inatethe
salm
onellarisk
Salmonella
50
Absence
in25
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
1.14.E
ggproducts,excluding
productswhere
themanufacturing
processor
thecom-
positio
nof
theproductwill
elim
inatethe
salm
onellarisk
Salmonella
50
Absence
in25
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
1.15.R
eady-to
-eat
foodscontaining
raw
egg,
excludingproductswhere
themanufac-
turin
gprocessor
thecompo
sitio
nof
the
productwill
elim
inatethesalm
onellarisk
Salmonella
50
Absence
in25
gor
ml
EN/IS
O65
79Productsplaced
onthemarket
during
theirshelf-life
1.16.C
ookedcrustaceansandmolluscan
shell-
fish
Salmonella
50
Absence
in25
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
1.17.Live
bivalvemolluscsandliveechino
-derm
s,tunicatesandgastropo
dsSalmonella
50
Absence
in25
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
L 338/10 EN Official Journal of the European Union 22.12.2005
Food
category
Micro-organisms/their
toxins,m
etabolites
Sampling-plan
(1)
Limits
(2)
Analyticalreference
metho
d(3)
Stagewhere
thecriterio
napplies
nc
mM
1.18.S
prou
tedseeds(ready-to-eat)(12)
Salmonella
50
Absence
in25
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
1.19.P
re-cut
fruitandvegetables
(ready-to-eat)
Salmonella
50
Absence
in25
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
1.20
.Unp
asteurised
fruitandvegetablejuices
(ready-to-eat)
Salmonella
50
Absence
in25
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
1.21.C
heeses,m
ilkpo
wderandwheypowder,
asreferred
toin
thecoagulase-po
sitive
staphylococcicriteria
inCh
apter2.2of
thisAnn
ex
Staphylococcalentero-
toxins
50
Not
detected
in25
gEuropean
screening
metho
dof
theCR
Lfor
Milk
(13)
Productsplaced
onthemarket
during
theirshelf-life
1.22
.Dried
infant
form
ulae
anddrieddietary
foodsforspecialm
edicalpu
rposes
intend
edforinfantsbelow
sixmon
thsof
age,as
referred
toin
theEnterobacter-
iaceae
criterion
inCh
apter2.2of
this
Ann
ex
Salmonella
300
Absence
in25
gEN
/ISO
6579
Productsplaced
onthemarket
during
theirshelf-life
1.23
.Dried
infant
form
ulae
anddrieddietary
foodsforspecialm
edicalpu
rposes
intend
edforinfantsbelow
sixmon
thsof
age,as
referred
toin
theEnterobacter-
iaceae
criterion
inCh
apter2.2of
this
Ann
ex
Enterobactersakazakii
300
Absence
in10
gISO/DTS
2296
4Productsplaced
onthemarket
during
theirshelf-life
1.24
.Livebivalvemolluscsandliveechino
-derm
s,tunicatesandgastropo
dsE.coli(14)
1 (15)
023
0MPN
/100
gof
flesh
and
intra-valvular
liquid
ISO
TS1664
9-3
Productsplaced
onthemarket
during
theirshelf-life
1.25
.Fishery
productsfrom
fishspeciesasso-
ciated
with
ahigh
amou
ntof
histidine(16)
Histamine
9 (17)
2100
mg/kg
200
mg/kg
HPLC(18)
Productsplaced
onthemarket
during
theirshelf-life
22.12.2005 EN Official Journal of the European Union L 338/11
Food
category
Micro-organisms/their
toxins,m
etabolites
Sampling-plan
(1)
Limits
(2)
Analyticalreference
metho
d(3)
Stagewhere
thecriterio
napplies
nc
mM
1.26
.Fishery
productswhich
have
undergon
eenzymematurationtreatm
entin
brine,
manufacturedfrom
fishspeciesassociated
with
ahigh
amou
ntof
histidine(16)
Histamine
92
200
mg/kg
400
mg/kg
HPLC(18)
Productsplaced
onthemarket
during
theirshelf-life
(1)
n=nu
mberof
units
comprisingthesample;c=nu
mberof
sampleun
itsgiving
values
over
mor
betweenm
andM.
(2)
Forpo
ints1.1-1.24
m=M
.(3)
Themostrecent
edition
ofthestandard
shallb
eused.
(4)
Regulartestingagainstthecriterio
nisno
tuseful
inno
rmalcircum
stancesforthefollowingready-to-eat
foods:
—thosewhich
have
received
heat
treatm
entor
otherprocessing
effectiveto
elim
inateL.
monocytogenes,w
henrecontam
inationisno
tpo
ssibleafterthistreatm
ent(e.g.p
roductsheat
treatedin
theirfin
alpackage),
—fresh,
uncutandun
processedvegetables
andfruits,excluding
sprouted
seeds,
—bread,
biscuitsandsimilarproducts,
—bo
ttled
orpacked
waters,softdrinks,b
eer,cider,wine,spirits
andsimilarproducts,
—sugar,ho
neyandconfectio
nery,including
cocoaandchocolateproducts,
—livebivalvemolluscs.
(5)
Thiscriterio
nappliesifthemanufacturerisableto
demon
strate,tothesatisfactionof
thecompetent
authority,thatthe
productw
illno
texceedthelim
it100cfu/gthrougho
uttheshelf-life.The
operator
may
fixinterm
ediatelim
itsduring
theprocessthat
shou
ldbe
low
enou
ghto
guaranteethat
thelim
itof
100cfu/gisno
texceeded
attheendof
theshelf-life.
(6)
1mlo
finoculum
isplated
onaPetrid
ishof
140mm
diam
eter
oron
threePetrid
ishesof
90mm
diam
eter.
(7)
Thiscriterio
nappliesto
productsbefore
they
have
lefttheim
mediatecontrolo
fthe
producingfood
businessop
erator,w
henhe
isno
tableto
demon
strate,tothesatisfactionof
thecompetent
authority,thatthe
productw
illno
texceed
thelim
itof
100cfu/gthrougho
uttheshelf-life.
(8)
Productswith
pH≤4,4or
a w≤0,92
,productswith
pH≤5,0anda w
≤0,94
,productswith
ashelf-life
oflessthan
fivedays
areautomaticallyconsidered
tobelong
tothiscategory.O
ther
categoriesof
productscanalso
belong
tothiscategory,subject
toscientificjustificatio
n.(9)
Thiscriterio
nappliesto
mechanically
separatedmeat(MSM
)producedwith
thetechniques
referred
toin
ChapterIII,paragraph
3,in
sectionVof
Ann
exIII
toRegulatio
n(EC)
No85
3/20
04of
theEuropean
Parliam
entand
ofthe
Coun
cilo
f29
April20
04laying
downspecifichygienerulesforfood
ofanim
alorigin.
(10)Excludingproductswhenthemanufacturercandemon
strate
tothesatisfactionof
thecompetent
authorities
that,d
ueto
theripening
timeanda w
oftheproductwhere
approp
riate,thereisno
salm
onellarisk.
(11)Onlyicecreamscontaining
milk
ingredients.
(12)Prelim
inarytestingof
thebatchof
seedsbefore
startin
gthesproutingprocessor
thesamplingto
becarriedou
tat
thestagewhere
thehighestprob
ability
offin
ding
Salmonellaisexpected.
(13)Reference:Hennekinn
eet
al.,J.AOACInternat.V
ol.8
6,No2,
2003
.(14)E.
coliisused
here
asan
indicatorof
faecalcontam
ination.
(15)Apo
oled
samplecomprisingaminim
umof
10individualanim
als.
(16)Particularly
fishspeciesof
thefamilies:S
combridae,C
lupeidae,E
ngraulidae,C
oryfenidae,P
omatom
idae,S
combresosidae.
(17)Singlesamples
may
betakenat
retaillevel.In
such
acase
thepresum
ptionlaid
downin
Article14(6)of
Regulatio
n(EC)
No178/20
02,according
towhich
thewho
lebatchshou
ldbe
deem
edun
safe,shallno
tapply.
(18)References:1
.MalleP.,V
alleM.,Bo
uqueletS.
Assay
ofbiogenicam
ines
involved
infishdecompo
sitio
n.J.AOACInternat.199
6,79
,43-49
.2.
DuflosG.,DervinC.,M
alleP.,B
ouquelet
S.Relevanceof
matrixeffect
indeterm
inationof
biogenicam
ines
inplaice
(Pleu
ronectesplatessa)andwhitin
g(M
erlangus
merlangus).J.AOACInternat.199
9,82
,109
7-1101.
L 338/12 EN Official Journal of the European Union 22.12.2005
Interpretatio
nof
thetest
results
Thelim
itsgivenreferto
each
sampleun
ittested,excluding
livebivalvemolluscsandliveechino
derm
s,tunicatesandgastropo
dsin
relatio
nto
testingE.
coli,where
thelim
itrefers
toapo
oled
sample.
Thetestresults
demon
strate
themicrobiologicalquality
ofthebatchtested
(1).
L.monocytogenesin
ready-to-eat
foodsintend
edforinfantsandforspecialm
edicalpu
rposes:
—satisfactory,ifallthe
values
observed
indicate
theabsenceof
thebacterium,
—un
satisfactory,ifthepresence
ofthebacterium
isdetected
inanyof
thesampleun
its.
L.monocytogenesin
ready-to-eatfoodsableto
supp
ortthe
grow
thof
L.monocytogenesbeforethefood
haslefttheim
mediatecontrolo
fthe
producingfood
businessop
erator
whenhe
isno
tableto
demon
strate
that
theproductwill
notexceed
thelim
itof
100cfu/gthrougho
uttheshelf-life:
—satisfactory,ifallthe
values
observed
indicate
theabsenceof
thebacterium,
—un
satisfactory,ifthepresence
ofthebacterium
isdetected
inanyof
thesampleun
its.
L.monocytogenesin
otherready-to-eat
foodsandE.
coliin
livebivalvemolluscs:
—satisfactory,ifallthe
values
observed
are≤thelim
it,
—un
satisfactory,ifanyof
thevalues
are>thelim
it.
Salmonellain
different
food
categories:
—satisfactory,ifallthe
values
observed
indicate
theabsenceof
thebacterium,
—un
satisfactory,ifthepresence
ofthebacterium
isdetected
inanyof
thesampleun
its.
22.12.2005 EN Official Journal of the European Union L 338/13
(1)
Thetestresults
canbe
used
also
fordemon
stratin
gtheeffectivenessof
theHACC
Por
good
hygieneprocedureof
theprocess.
Staphylococcalenterotoxins
indairyproducts:
—satisfactory,ifin
allthe
sampleun
itstheenterotoxins
areno
tdetected,
—un
satisfactory,iftheenterotoxins
aredetected
inanyof
thesampleun
its.
Enterobactersakazakiiindriedinfant
form
ulae
anddrieddietaryfoodsforspecialm
edicalpu
rposes
intend
edforinfantsbelow
6mon
thsof
age:
—satisfactory,ifallthe
values
observed
indicate
theabsenceof
thebacterium,
—un
satisfactory,ifthepresence
ofthebacterium
isdetected
inanyof
thesampleun
its.
Histaminein
fishery
productsfrom
fishspeciesassociated
with
ahigh
amou
ntof
histidine:
—satisfactory,ifthefollowingrequirementsarefulfilled:
1.themeanvalueob
served
is≤m
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
.
L 338/14 EN Official Journal of the European Union 22.12.2005
Chapter
2.Processhy
gien
ecrite
ria
2.1.
Meatandprod
ucts
thereo
f
Food
category
Micro-organisms
Samplingplan
(1)
Limits
(2)
Analyticalreference
metho
d(3)
Stagewhere
the
criterio
napplies
Actionin
case
ofun
satisfactory
results
nc
mM
2.1.1.
Carcases
ofcattle,sheep,
goatsand
horses
(4)
Aerob
iccolony
coun
t3,5log
cfu/cm
2
daily
mean
log
5,0log
cfu/cm
2
daily
mean
log
ISO
4833
Carcases
afterdres-
sing
butbefore
chil-
ling
Improvem
entsin
slaughter
hygieneandreview
ofpro-
cess
controls
Enterobacteriaceae
1,5log
cfu/cm
2
daily
mean
log
2,5log
cfu/cm
2
daily
mean
log
ISO
2152
8-2
Carcases
afterdres-
sing
butbefore
chil-
ling
Improvem
entsin
slaughter
hygieneandreview
ofpro-
cess
controls
2.1.2.
Carcases
ofpigs
(4)
Aerob
iccolony
coun
t4,0log
cfu/cm
2
daily
mean
log
5,0log
cfu/cm
2
daily
mean
log
ISO
4833
Carcases
afterdres-
sing
butbefore
chil-
ling
Improvem
entsin
slaughter
hygieneandreview
ofpro-
cess
controls
Enterobacteriaceae
2,0log
cfu/cm
2
daily
mean
log
3,0log
cfu/cm
2
daily
mean
log
ISO
2152
8-2
Carcases
afterdres-
sing
butbefore
chil-
ling
Improvem
entsin
slaughter
hygieneandreview
ofpro-
cess
controls
2.1.3.
Carcases
ofcattle,sheep,
goatsand
horses
Salmonella
50(5)
2(6)
Absence
inthearea
tested
percarcase
EN/IS
O65
79Carcases
afterdres-
sing
butbefore
chil-
ling
Improvem
entsin
slaughter
hygiene,review
ofprocess
controlsandof
origin
ofanim
als
2.1.4.
Carcases
ofpig
Salmonella
50(5)
5(6)
Absence
inthearea
tested
percarcase
EN/IS
O65
79Carcases
afterdres-
sing
butbefore
chil-
ling
Improvem
entsin
slaughter
hygieneandreview
ofpro-
cess
controls,o
riginof
ani-
malsandof
thebiosecurity
measuresin
thefarm
sof
origin
2.1.5.
Poultrycarcases
ofbroilersandturkeys
Salmonella
50(5)
7(6)
Absence
in25
gof
apo
oled
sampleof
neck
skin
EN/IS
O65
79Carcasesafterchilling
Improvem
entsin
slaughter
hygieneandreview
ofpro-
cess
controls,o
riginof
ani-
malsandbiosecurity
measuresin
thefarm
sof
origin
22.12.2005 EN Official Journal of the European Union L 338/15
Food
category
Micro-organisms
Samplingplan
(1)
Limits
(2)
Analyticalreference
metho
d(3)
Stagewhere
the
criterio
napplies
Actionin
case
ofun
satisfactory
results
nc
mM
2.1.6.
Mincedmeat
Aerob
iccolony
coun
t(7 )
52
5x10
5
cfu/g
5x10
6
cfu/g
ISO
4833
Endof
themanufac-
turin
gprocess
Improvem
entsin
productio
nhygieneandim
provem
ents
inselectionand/or
origin
ofraw
materials
E.coli(8)
52
50cfu/g
500cfu/g
ISO
1664
9-1or
2Endof
themanufac-
turin
gprocess
Improvem
entsin
productio
nhygieneandim
provem
ents
inselectionand/or
origin
ofraw
materials
2.1.7.Mechanically
separatedmeat(M
SM)(
9 )Aerob
iccolony
coun
t5
25x10
5
cfu/g
5x10
6
cfu/g
ISO
4833
Endof
themanufac-
turin
gprocess
Improvem
entsin
productio
nhygieneandim
provem
ents
inselectionand/or
origin
ofraw
materials
E.coli(8)
52
50cfu/g
500cfu/g
ISO
1664
9-1or
2Endof
themanufac-
turin
gprocess
Improvem
entsin
productio
nhygieneandim
provem
ents
inselectionand/or
origin
ofraw
materials
2.1.8.
Meatpreparations
E.coli(8)
52
500cfu/g
orcm
2500
0cfu/
gor
cm2
ISO
1664
9-1or
2Endof
themanufac-
turin
gprocess
Improvem
entsin
productio
nhygieneandim
provem
ents
inselectionand/or
origin
ofraw
materials
(1)
n=nu
mberof
units
comprisingthesample;c=nu
mberof
sampleun
itsgiving
values
betweenm
andM.
(2)
Forpo
ints2.1.3—
2.1.5m=M
.(3)
Themostrecent
edition
ofthestandard
shallb
eused.
(4)
Thelim
its(m
andM)applyon
lyto
samples
takenby
thedestructivemetho
d.Th
edaily
meanlogiscalculated
byfirsttaking
alogvalueof
each
individualtestresultandthen
calculatingthemeanof
theselogvalues.
(5)
The50
samples
arederivedfrom
10consecutivesamplingsessions
inaccordance
with
thesamplingrulesandfrequencieslaid
downin
thisRegulatio
n.(6)
Thenu
mberof
samples
where
thepresence
ofsalm
onellaisdetected.T
hecvalueissubjecttoreview
inorderto
take
into
accoun
tthe
progress
madein
reducing
thesalm
onellaprevalence.M
emberStates
orregion
shaving
low
salm
onellaprevalence
may
uselower
cvalues
even
before
thereview
.(7)
Thiscriterio
ndoes
notapplyto
mincedmeatproduced
atretaillevelw
hentheshelf-life
oftheproductisless
then
24ho
urs.
(8)
E.coliisused
here
asan
indicatorof
faecalcontam
ination.
(9)
Thesecriteria
applyto
mechanically
separatedmeat(MSM
)producedwith
thetechniques
referred
toin
ChapterIII,p
aragraph
3,in
sectionVof
Ann
exIII
ofRegulatio
n(EC)
No85
3/20
04of
theEuropean
Parliam
entandof
the
Coun
cilo
f29
April20
04laying
downspecifichygienerulesforfood
ofanim
alorigin.
L 338/16 EN Official Journal of the European Union 22.12.2005
Interpretatio
nof
thetest
results
Thelim
itsgivenreferto
each
sampleun
ittested,excluding
testingof
carcases
where
thelim
itsreferto
pooled
samples.
Thetestresults
demon
strate
themicrobiologicalquality
oftheprocesstested.
Enterobacteriaceae
andaerobiccolony
coun
tin
carcases
ofcattle,sheep,
goats,ho
rses
andpigs:
—satisfactory,ifthedaily
meanlogis<m,
—acceptable,ifthedaily
meanlogisbetweenm
andM,
—un
satisfactory,ifthedaily
meanlogis>M
.
Salmonellain
carcases:
—satisfactory,ifthepresence
ofSalmonellaisdetected
inamaxim
umof
c/nsamples,
—un
satisfactory,ifthepresence
ofSalmonellaisdetected
inmorethan
c/nsamples.
After
each
samplingsession,
theresults
ofthelasttensamplingsessions
areassessed
inorderto
obtain
thennu
mberof
samples.
E.coliandaerobiccolony
coun
tin
mincedmeat,meatpreparations
andmechanically
separatedmeat(M
SM):
—satisfactory,ifallthe
values
observed
are<m,
—acceptable,ifamaxim
umof
c/nvalues
arebetweenm
andM,and
therestof
thevalues
observed
are<m,
—un
satisfactory,ifon
eor
moreof
thevalues
observed
are>M
ormorethan
c/nvalues
arebetweenm
andM.
22.12.2005 EN Official Journal of the European Union L 338/17
2.2.
Milk
anddairyprod
ucts
Food
category
Micro-organisms
Samplingplan
(1)
Limits
(2)
Analyticalreference
metho
d(3)
Stagewhere
the
criterio
napplies
Actionin
case
ofun
satisfactory
results
nc
mM
2.2.1.
Pasteurised
milk
andotherpasteurised
liquiddairyproducts(4)
Enterobacteriaceae
52
<1cfu/ml
5cfu/ml
ISO
2152
8-1
Endof
themanufac-
turin
gprocess
Checkon
theefficiencyof
heat-treatm
entandpreven-
tionof
recontam
inationas
wellasthequality
ofraw
materials
2.2.2.
Cheesesmadefrom
milk
orwheythat
hasun
dergon
eheat
treatm
ent
E.coli(5)
52
100cfu/g
100
0cfu/
gISO
1664
9-1or
2Atthetim
eduring
themanufacturing
processwhentheE.
colicoun
tisexpected
tobe
highest(
6 )
Improvem
entsin
productio
nhygieneandselectionof
raw
materials
2.2.3.
Cheesesmadefrom
raw
milk
Coagulase-po
sitive
staphylococci
52
104cfu/g
105cfu/g
EN/IS
O68
88-2
Atthetim
eduring
themanufacturing
processwhenthe
numberof
staphylo-
cocciisexpected
tobe
highest
Improvem
entsin
productio
nhygieneandselectionof
raw
materials.Ifvalues>1
05cfu/g
aredetected,the
cheese
batch
hasto
betested
forstaphy-
lococcalenterotoxins.
2.2.4.
Cheesesmadefrom
milk
that
has
undergon
ealower
heattreatm
entthan
pasteurisation(7)andripenedcheeses
madefrom
milk
orwheythat
has
undergon
epasteurisationor
astronger
heat
treatm
ent(
7 )
Coagulase-po
sitive
staphylococci
52
100cfu/g
100
0cfu/
gEN
/ISO
6888
-1or
2
2.2.5.
Unripened
softcheeses(freshcheeses)
madefrom
milk
orwheythat
has
undergon
epasteurisationor
astronger
heat
treatm
ent(
7 )
Coagulase-po
sitive
staphylococci
52
10cfu/g
100cfu/g
EN/IS
O68
88-1
or2
Endof
themanufac-
turin
gprocess
Improvem
entsin
productio
nhygiene.Ifvalues
>10
5cfu/g
aredetected,the
cheese
batch
hasto
betested
forstaphy-
lococcalenterotoxins.
2.2.6.
Butterandcream
madefrom
raw
milk
ormilk
that
hasun
dergon
ealower
heat
treatm
entthan
pasteurisatio
n
E.coli(5)
52
10cfu/g
100cfu/g
ISO
1664
9-1or
2Endof
themanufac-
turin
gprocess
Improvem
entsin
productio
nhygieneandselectionof
raw
materials
L 338/18 EN Official Journal of the European Union 22.12.2005
Food
category
Micro-organisms
Samplingplan
(1)
Limits
(2)
Analyticalreference
metho
d(3)
Stagewhere
the
criterio
napplies
Actionin
case
ofun
satisfactory
results
nc
mM
2.2.7.Milk
powderandwheypo
wder(
4 )Enterobacteriaceae
50
10cfu/g
ISO
2152
8-1
Endof
themanufac-
turin
gprocess
Checkon
theefficiencyof
heat
treatm
entandpreven-
tionof
recontam
ination
Coagulase-po
sitive
staphylococci
52
10cfu/g
100cfu/g
EN/IS
O68
88-1
or2
Endof
themanufac-
turin
gprocess
Improvem
entsin
productio
nhygiene.Ifvalues
>10
5cfu/g
aredetected,the
batchhasto
betested
forstaphylococcal
enterotoxins.
2.2.8.
Icecream
(8)andfrozen
dairydesserts
Enterobacteriaceae
52
10cfu/g
100cfu/g
ISO
2152
8-2
Endof
themanufac-
turin
gprocess
Improvem
entsin
productio
nhygiene
2.2.9.
Dried
infant
form
ulae
anddrieddietary
foodsforspecialm
edicalpu
rposes
intend
edforinfantsbelow
sixmon
ths
ofage
Enterobacteriaceae
100
Absence
in10
gISO
2152
8-1
Endof
themanufac-
turin
gprocess
Improvem
entsin
productio
nhygieneto
minim
isecon-
tamination.
IfEnterobacter-
iaceae
aredetected
inanyof
thesampleun
its,the
batch
hasto
betested
forE.
sakazakiiand
Salmonella
(1)
n=nu
mberof
units
comprisingthesample;c=nu
mberof
sampleun
itsgiving
values
betweenm
andM.
(2)
Forpo
int2.2.7m=M
.(3)
Themostrecent
edition
ofthestandard
shallb
eused.
(4)
Thecriterion
does
notapplyto
productsintend
edforfurtherprocessing
inthefood
industry.
(5)
E.coliisused
here
asan
indicatorforthelevelo
fhygiene.
(6)
Forcheeseswhich
areno
tableto
supp
ortthe
grow
thof
E.coli,theE.colicoun
tisusually
thehighestatthe
beginn
ingof
theripening
period,and
forcheeseswhich
areableto
supp
ortthe
grow
thof
E.coli,itisno
rmallyattheendof
theripening
period.
(7)
Excludingcheeseswhere
themanufacturercandemon
strate,tothesatisfactionof
thecompetent
authorities,thattheproductdoes
notpo
searisk
ofstaphylococcalenterotoxins.
(8)
Onlyicecreamscontaining
milk
ingredients.
22.12.2005 EN Official Journal of the European Union L 338/19
Interpretatio
nof
thetest
results
Thelim
itsgivenreferto
each
sampleun
ittested.
Thetestresults
demon
strate
themicrobiologicalquality
oftheprocesstested.
Enterobacteriaceae
indriedinfant
form
ulae
anddrieddietaryfoodsforspecialm
edicalpu
rposes
intend
edforinfantsbelow
sixmon
thsof
age:
—satisfactory,ifallthe
values
observed
indicate
theabsenceof
thebacterium,
—un
satisfactory,ifthepresence
ofthebacterium
isdetected
inanyof
thesampleun
its
E.coli,enterobacteriaceae
(other
food
categories)andcoagulase-po
sitivestaphylococci:
—satisfactory,ifallthe
values
observed
are<m,
—acceptable,ifamaxim
umof
c/nvalues
arebetweenm
andM,and
therestof
thevalues
observed
are<m,
—un
satisfactory,ifon
eor
moreof
thevalues
observed
are>M
ormorethan
c/nvalues
arebetweenm
andM.
L 338/20 EN Official Journal of the European Union 22.12.2005
2.3.
Eggprod
ucts
Food
category
Micro-organisms
Samplingplan
(1)
Limits
Analyticalreference
metho
d(2)
Stagewhere
the
criterio
napplies
Actionin
case
ofun
satisfactory
results
nc
mM
2.3.1.
Eggproducts
Enterobacteriaceae
52
10cfu/gor
ml
100cfu/g
orml
ISO
2152
8-2
Endof
themanufac-
turin
gprocess
Checks
ontheefficiencyof
theheat
treatm
entand
preventio
nof
recontam
ina-
tion
(1)
n=nu
mberof
units
comprisingthesample;c=nu
mberof
sampleun
itsgiving
values
betweenm
andM.
(2)
Themostrecent
edition
ofthestandard
shallb
eused.
Interpretatio
nof
thetest
results
Thelim
itsgivenreferto
each
sampleun
ittested.
Thetestresults
demon
strate
themicrobiologicalquality
oftheprocesstested.
Enterobacteriaceae
ineggproducts:
—satisfactory,ifallthe
values
observed
are<m,
—acceptable,ifamaxim
umof
c/nvalues
arebetweenm
andM,and
therestof
thevalues
observed
are<m,
—un
satisfactory,ifon
eor
moreof
thevalues
observed
are>M
ormorethan
c/nvalues
arebetweenm
andM.
22.12.2005 EN Official Journal of the European Union L 338/21
2.4.
Fisheryprod
ucts
Food
category
Micro-organisms
Samplingplan
(1)
Limits
Analyticalreference
metho
d(2)
Stagewhere
the
criterio
napplies
Actionin
case
ofun
satisfactory
results
nc
mM
2.4.1.
Shelledandshuckedproductsof
cooked
crustaceansandmolluscan
shellfish
E.coli
52
1cfu/g
10cfu/g
ISO
TS1664
9-3
Endof
themanufac-
turin
gprocess
Improvem
entsin
productio
nhygiene
Coagulase-po
sitive
staphylococci
52
100cfu/g
100
0cfu/
gEN
/ISO
6888
-1or
2Endof
themanufac-
turin
gprocess
Improvem
entsin
productio
nhygiene
(1)
n=nu
mberof
units
comprisingthesample;c=nu
mberof
sampleun
itsgiving
values
betweenm
andM.
(2)
Themostrecent
edition
ofthestandard
shallb
eused.
Interpretatio
nof
thetest
results
Thelim
itsgivenreferto
each
sampleun
ittested.
Thetestresults
demon
strate
themicrobiologicalquality
oftheprocesstested.
E.coliin
shelledandshuckedproductsof
cooked
crustaceansandmolluscan
shellfish:
—satisfactory,ifallthe
values
observed
are<m,
—acceptable,ifamaxim
umof
c/nvalues
arebetweenm
andM,and
therestof
thevalues
observed
are≤m,
—un
satisfactory,ifon
eor
moreof
thevalues
observed
are>M
ormorethan
c/nvalues
arebetweenm
andM.
Coagulase-po
sitivestaphylococciinshelledandcooked
crustaceansandmolluscan
shellfish:
—satisfactory,ifallthe
values
observed
are<m,
—acceptable,ifamaxim
umof
c/nvalues
arebetweenm
andM,and
therestof
thevalues
observed
are<m,
—un
satisfactory,ifon
eor
moreof
thevalues
observed
are>M
ormorethan
c/nvalues
arebetweenm
andM.
L 338/22 EN Official Journal of the European Union 22.12.2005
2.5.
Vegetables,fruits
andprod
ucts
thereo
f
Food
category
Micro-organisms
Samplingplan
(1)
Limits
Analyticalreference
metho
d(2)
Stagewhere
the
criterio
napplies
Actionin
case
ofun
satisfactory
results
nc
mM
2.5.1.
Pre-cutfruitandvegetables
(ready-to-
eat)
E.coli
52
100cfu/g
100
0cfu/
gISO
1664
9-1or
2Manufacturing
pro-
cess
Improvem
entsin
productio
nhygiene,selectionof
raw
materials
2.5.2.
Unp
asteurised
fruitand
vegetablejuices
(ready-to-eat)
E.coli
52
100cfu/g
100
0cfu/
gISO
1664
9-1or
2Manufacturing
pro-
cess
Improvem
entsin
productio
nhygiene,selectionof
raw
materials
(1)
n=nu
mberof
units
comprisingthesample;c=nu
mberof
sampleun
itsgiving
values
betweenm
andM.
(2)
Themostrecent
edition
ofthestandard
shallb
eused.
Interpretatio
nof
thetest
results
Thelim
itsgivenreferto
each
sampleun
ittested.
Thetestresults
demon
strate
themicrobiologicalquality
oftheprocesstested.
E.coliin
pre-cutfruitandvegetables
(ready-to-eat)andin
unpasteurised
fruitandvegetablejuices
(ready-to-eat):
—satisfactory,ifallthe
values
observed
are<m,
—acceptable,ifamaxim
umof
c/nvalues
arebetweenm
andM,and
therestof
thevalues
observed
are≤m,
—un
satisfactory,ifon
eor
moreof
thevalues
observed
are>M
ormorethan
c/nvalues
arebetweenm
andM.
22.12.2005 EN Official Journal of the European Union L 338/23
Chapter 3. Rules for sampling and preparation of test samples
3.1. General rules for sampling and preparation of test samples
In the absence of more specific rules on sampling and preparation of test samples, the relevant standards of the ISO(International Organisation for Standardisation) and the guidelines of the Codex Alimentarius shall be used asreference methods.
3.2. Bacteriological sampling in slaughterhouses and at premises producing minced meat and meatpreparations
Sampling rules for carcases of cattle, pigs, sheep, goats and horses
The destructive and non-destructive sampling methods, the selection of the sampling sites and the rules for storageand transport of samples are described in standard ISO 17604.
Five carcases shall be sampled at random during each sampling session. Sample sites should be selected taking intoaccount the slaughter technology used in each plant.
When sampling for analyses of enterobacteriaceae and aerobic colony counts, four sites of each carcase shall besampled. Four tissue samples representing a total of 20 cm2 shall be obtained by the destructive method. When usingthe non-destructive method for this purpose, the sampling area shall cover a minimum of 100 cm2 (50 cm2 for smallruminant carcases) per sampling site.
When sampling for Salmonella analyses, an abrasive sponge sampling method shall be used. The sampling area shallcover a minimum of 100 cm2 per site selected.
When samples are taken from the different sampling sites on the carcase, they shall be pooled before examination.
Sampling rules for poultry carcases
For the Salmonella analyses, a minimum of 15 carcases shall be sampled at random during each sampling session andafter chilling. A piece of approximately 10 g from neck skin shall be obtained from each carcase. On each occasion theneck skin samples from three carcases shall be pooled before examination in order to form 5 x 25 g final samples.
Guidelines for sampling
More detailed guidelines on the sampling of carcases, in particular concerning the sampling sites, may be included inthe guides to good practice referred to in Article 7 of Regulation (EC) No 852/2004.
Sampling frequencies for carcases, minced meat, meat preparations and mechanically separated meat
However, when justified on the basis of a risk analysis and consequently authorised by the competent authority, smallslaughterhouses and establishments producing minced meat and meat preparations in small quantities may beexempted from these sampling frequencies.
In the case of sampling for Salmonella analyses of minced meat, meat preparations and carcases, the frequency can bereduced to fortnightly if satisfactory results have been obtained for 30 consecutive weeks. The salmonella samplingfrequency may also be reduced if there is a national or regional salmonella control programme in place and if thisprogramme includes testing that replaces the described sampling. The sampling frequency may be further reduced ifthe national or regional salmonella control programme demonstrates that the salmonella prevalence is low in animalspurchased by the slaughterhouse.
As regards the sampling of minced meat and meat preparations for E. coli and aerobic colony count analyses and thesampling 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.
L 338/24 EN Official Journal of the European Union 22.12.2005
The food business operators of slaughterhouses or establishments producing minced meat, meat preparations ormechanically separated meat shall take samples for microbiological analysis at least once a week. The day of samplingshall be changed each week to ensure that each day of the week is covered.
22.12.2005 EN Official Journal of the European Union L 338/25
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 ofpreservatives and the type of packaging system, taking into account the storage and processing conditions, thepossibilities for contamination and the foreseen shelf-life, and
— consultation of available scientific literature and research data regarding the growth and survival characteristicsof the micro-organisms of concern.
When necessary on the basis of the abovementioned studies, the food business operator shall conduct additionalstudies, which may include:
— predictive mathematical modelling established for the food in question, using critical growth or survival factorsfor the micro-organisms of concern in the product,
— tests to investigate the ability of the appropriately inoculated micro-organism of concern to grow or survive inthe product under different reasonably foreseeable storage conditions,
— studies to evaluate the growth or survival of the micro-organisms of concern that may be present in the productduring the shelf-life under reasonably foreseeable conditions of distribution, storage and use.
The above mentioned studies shall take into account the inherent variability linked to the product, the micro-organisms in question and the processing and storage conditions.
L 338/26 EN Official Journal of the European Union 22.12.2005