(Text with EEA relevance) - Food Safety Authority of Ireland1).pdf · (Text with EEA relevance) ......

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.

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).

(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.

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).

(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.



(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;


(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.

(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


(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.


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


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


Chapter

1.Fo

odsafety

crite

ria

Food

category

Micro-organisms/their

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Sampling-plan

(1)

Limits

(2)

Analyticalreference

metho

d(3)

Stagewhere

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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

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ortthe

grow

thof

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ther

than

thoseintend

edforinfantsandforspecial

medicalpu

rposes

Listeria

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50

100cfu/g(5)

EN/IS

O1129

0-2(6)

Productsplaced

onthemarket

during

theirshelf-life

50

Absence

in25

g(7)

EN/IS

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Before

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hasleftthe

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1.3.

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rposes

(4)(

8 )

Listeria

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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


Food

category


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


Food

category


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


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


Food

category


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


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.


Interpretatio

nof

thetest

results

Thelim

itsgivenreferto

each

sampleun

ittested,excluding

livebivalvemolluscsandliveechino

derm


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:


values

observed

indicate

theabsenceof

thebacterium,

—un


ofthebacterium

isdetected

inanyof

thesampleun

its.

L.monocytogenesin

otherready-to-eat

foodsandE.

coliin

livebivalvemolluscs:


values

observed

are≤thelim

it,

—un

satisfactory,ifanyof

thevalues

are>thelim

it.

Salmonellain

different

food

categories:


values

observed

indicate

theabsenceof

thebacterium,

—un


ofthebacterium

isdetected

inanyof

thesampleun

its.


(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:


values

observed

indicate

theabsenceof

thebacterium,

—un


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

.


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


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


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.


Interpretatio

nof

thetest

results

Thelim

itsgivenreferto

each

sampleun

ittested,excluding

testingof

carcases

where

thelim

itsreferto

pooled

samples.

Thetestresults

demon

strate


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


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):


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.


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


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


raw

materials


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


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


thecompetent

authorities,thattheproductdoes

notpo

searisk

ofstaphylococcalenterotoxins.

(8)

Onlyicecreamscontaining

milk

ingredients.


Interpretatio

nof

thetest

results

Thelim

itsgivenreferto

each

sampleun

ittested.

Thetestresults

demon

strate


oftheprocesstested.

Enterobacteriaceae

indriedinfant

form

ulae

anddrieddietaryfoodsforspecialm

edicalpu

rposes

intend

edforinfantsbelow

sixmon

thsof

age:


values

observed

indicate

theabsenceof

thebacterium,

—un


ofthebacterium

isdetected

inanyof

thesampleun

its

E.coli,enterobacteriaceae

(other

food

categories)andcoagulase-po

sitivestaphylococci:


values

observed

are<m,


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.


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


mberof

sampleun

itsgiving

values

betweenm

andM.

(2)

Themostrecent

edition

ofthestandard

shallb

eused.

Interpretatio

nof

thetest

results

Thelim

itsgivenreferto

each

sampleun

ittested.

Thetestresults

demon

strate


oftheprocesstested.

Enterobacteriaceae

ineggproducts:


values

observed

are<m,


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.


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


mberof

sampleun

itsgiving

values

betweenm

andM.

(2)

Themostrecent

edition

ofthestandard

shallb

eused.

Interpretatio

nof

thetest

results

Thelim

itsgivenreferto

each

sampleun

ittested.

Thetestresults

demon

strate


oftheprocesstested.

E.coliin

shelledandshuckedproductsof

cooked


shellfish:


values

observed

are<m,


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


shellfish:


values

observed

are<m,


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.


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


mberof

sampleun

itsgiving

values

betweenm

andM.

(2)

Themostrecent

edition

ofthestandard

shallb

eused.

Interpretatio

nof

thetest

results

Thelim

itsgivenreferto

each

sampleun

ittested.

Thetestresults

demon

strate


oftheprocesstested.

E.coliin

pre-cutfruitandvegetables

(ready-to-eat)andin

unpasteurised

fruitandvegetablejuices

(ready-to-eat):


values

observed

are<m,


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.


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.


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.


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.


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