Good manufacturing practice guidelines Live bivalves workbook

A step-by-step guide togood live bivalve

preparation for the market

Good manufacturing practice guidelines

Live bivalves workbook

PROJECT PART-FINANCED BY THE EUROPEAN UNION THROUGH THE FINANCIAL

INSTRUMENT FOR FISHERIES GUIDANCE

Navigato

r to

ol ste

ps:

Contents page

Good manufacturing practice guidelinesLive bivalves workbook

Step Navigational tool bar – area

page 3 Introduction

Page 4 How to use this workbook

1-3 Harvesting

4-7 Onshore handling

8-9 Relaying

10-11 Dispatch

12-15 Purification

16-19 Purification - HACCP

20-21 Wrapping and packing

22-24 Storage and dispatch

Appendix 1 Classification of bivalve shellfish waters

Appendix 2 Bivalve shellfish biotoxin limits

Appendix 3 Product standard for live bivalve shellfish

Appendix 4 Record keeping – general

Appendix 5 Record keeping – registration document

Appendix 6 The european hygiene regulations

Acknowledgements

Introduction•Thisworkbookisintendedtoassistlivebivalveshellfishoperatorsproduceahighquality,saferlivebivalveincompliancewithlegalobligations.Itisdesignedtobeusedintheproductionenvironment,onboardtheharvestingvesselorforeshore.

•Itisintendedthatoperatorswillusetheworkbookasaneverydayguidefor :

– Goodmanufacturingpracticeandlegalcompliance. – Onthejobandinductiontraining. – Referenceinformationongoodworkpractices.

•TheworkbookcontainstheessentialworkpracticesandproceduresthatoperatorsmustadheretoinordertobecompliantwiththeEuropeanHygieneRegulations.TheseRegulationscameintoforceinJanuary2006andapplytotheplacingoflivebivalveshellfishonthemarketforhumanconsumption.AfullerexplanationoftheseRegulationsisgiveninAppendix6.

•TheworkbookalsocontainsSeafishadviceintheformofGoodManufacturingPracticeGuidance(GMPG)ateachstepintheproductionprocesstohelpoperatorsplacehighqualitylivebivalvemolluscsonthemarket.

•Theworkbookisstructuredintoaseriesofstepsfrom1to24,eachcoveringthedifferentprocessesintheproductionchain,fromharvestingtodeliveryoflivebivalvestomarket.TheNavigatorToolrunningdowntherighthandsidewillallowthereadertolocateeachstepinrespecttotheoverallchain.

•TheworkbookisaccompaniedbyasetofsixlaminatedWorkNoticeswhichcanbepostedonnoticeboards.Theirclearandsimpledesignwillallowforgoodqualityphotocopyreproduction.

•Thisworkbookispar tofasuiteofSeafishpublicationsonGoodManufacturingPracticeGuidanceforlivebivalvemolluscs.

•Forfur therinformation,readersshouldcontact:

TheInformationOfficer Seafish SeafishHouse, StAndrew’sDock, HullHU34QE T:01482327837F:01482223310 E:[email protected]

Navigato

r to

ol ste

ps:


1 Thistextboxtellsyouwhatyoumustdoin

ordertomeetthelegalrequirementsofthe EuropeanHygieneRegulations.

2 Thewordsmust or must notanddoanddo notareusedinbold red texttore-enforce thelegalrequirement.

3 AtthebottomofeachpagethereisaredLegal ReferenceBoxcontainingtheexactsectionof theEuropeanRegulationswhichdetailsthe legalrequirement.

4 ThistextboxcontainsSeafishadviceonGMPG.5 Seafishadviceisintendedtomaintainthe

qualityandextendtheshelf-lifeoftheproduct.

Theword ‘Remember’isusedtodistinguish LegalRequirementsfromSeafishGood ManufacturingPracticeGuidance(GMPG).

Bulletpoint

Legal obligation reference SeafishGMPG

1-3 ReferencetoEuropeanLegislationhere

4-6 NolegalrequirementbutSeafishadvise

How to use this workbook

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

6 AtickintheLegalReferenceBoxmeansthatit

isintendedasSeafishadviceforGMPG.Often, GMPGandLegalRequirementsoverlap.

Navigato

r to

ol ste

ps:


1 Youmustonlyharvestfromclassifiedwaters;

A,BorC–refertoAppendix1.

2 LivebivalvesmustmeetthelegalEndProduct StandarddescribedinAppendix3ofthe workbook.

1-3

Ha

rvestin

g

3 Harvestedbivalvesmustmeetthelegallimitfor naturallyoccurringmarinebiotoxinsdescribedin Appendix2–complywithanyClosureOrders.

4 Don’tharvestfromareasheavily contaminatedwith: (i) Sewagewaste. (ii) Industrialwaste. (iii)Highpresenceofheavymetals.

Remember:

Bulletpoint


1 853/2004,AnnexIII,SectionVII,ChapII,A(1)

1 854/2004,AnnexII,ChapterII,A(1-5)

22

853/2004,AnnexIII,SectionVII,ChapVReg2073/2005Annex1Chap1.17ans1.24

3 853/2004,AnnexIII,SectionVII,ChapV,2(a-e)

4 -------------------

Step 1 The growing/ harvest area

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

Navigato

r to

ol ste

ps:


1 Harvestingoperationsmust not contaminate

ordamagetheanimals.

2 Youmustkeephandling,sorting,grading equipmentcleanandingoodrepair.

1-3

Ha

rvestin

g

3 Youmuststorebivalvesinclean, drainablecontainers.

4 Avoidcontaminationfrom: (i) Boatsewagewaste. (ii) Smokeorfueloil. (iii) Lubricantsanddisinfectants. (iv) Pestandbirddroppings.

Remember:

Bulletpoint


1 853/2004,AnnexIII,SectionVII,ChapII,B1

2 852/2004,AnnexI,PartA,II4(a-b)

3 852/2004,AnnexI,PartA,II4(b)

4-5 -------------------

Step 2 Harvesting vessel, raft or foreshore equipment

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

5 Usere-usableplasticboxes–notwoodenboxes. Sometypesofbagswillbesuitableforuse withscallops.

Navigato

r to

ol ste

ps:


1 Youmustbeabletoidentifyeachbatchof

bivalvesbyproduction,relayingordesignated harvestingarea.

2 Fillinaregistrationdocumentforeachbatch harvestedfromadifferentarea(previously calledaMovementDocument).

1-3

Ha

rvestin

g

3 Youmustmakesurethattheyarekeptalive andingoodcondition.

5 Don’tmixbatchesfromdifferentharvestareas.6 Keepthemcool.

Remember:

Bulletpoint


1 853/2004,AnnexIII,SectionVII,ChapI,4(a)iii,4(b)iand178/2002Article181-5

2 853/2004AnnexIII,SectionVII,ChapI,3&4(a)i-vi,4(b)i-ii

3 853/2004,AnnexIII,SectionVII,ChapIIB,1

4 853/2004,AnnexIII,SectionVII,ChapII,B,1(c)

5-10 -------------------

7 Keepthemmoistbutallowthemtodrain.

8 Clean,washandgradethemgently.

9 Nevertread,stampordropthemtode-clump.

10 Washshellsfreeofmudanddirtbeforeitdrieshard.

Step 3 On board handling

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

4 Youmust notre-immersetheminwaterthat couldcauseadditionalcontamination.

Navigato

r to

ol ste

ps:


2 Youmustusecleanwateronly.

3 Landbivalvesinprotectivecontainersor suitablebags(donotuseplasticbags).

Remember:

Step 4 On Shore reception

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

6 Ifreceptionareaisoutdoors,loadtransportation withoutdelay.

1 Youmust notallowcontaminationfrom: (i) Dirtanddirtywater (ii) Pestssuchasmice,ratsandbirds (iii)Chemicals,oils,fuelsordetergents.

4 Donotimmerseinfreshwater.

5 Landthemtoclean,harddrainablesurfaces.

Bulletpoint


1(i-iii) 853/2004AnnexIIISectionVIIChapIIB1(c)

1 (ii) 852/2004AnnexIPartAII4(f)

1(iii) 852/2004AnnexIPartAII3(a)&4(g)

2 852/2004AnnexIPartAII4(d)&ChapIArticle2.1(h)&(i)

3-6 -------------------

4-7

On

sho

reh

and

lingN

avigator

tool ste

ps:


2 Transportmustallowadequatedrainage.

4 Protectfromdirt,rainandexcessivewind andsun.

Remember:

Step 5 Raw material transport

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

7 Avoidbulkuncontainerisedtransport.

1 Youmustkeeptransporttrucksclean.

5 Useopentransportforshortjourneysonly.

6 Keepbivalvescovered–egcleantarpaulins.

Bulletpoint


1 852/2004AnnexIPartAII4(b)&AnnexIIChapterIV1

2-3 853/2004AnnexIIISectionVIIChapII,B(2)

4-8 -------------------

3 Bivalvesmustbeprotectedfromcontamination.

8 Usedurableplasticboxesorbulkbagswhere appropriate(egmussels).

4-7

On

sho

reh

and

lingN

avigator

tool ste

ps:


3 Youmusttransportlivebivalvesatthe appropriatetemperature.

4 Loadtransporttrucksassoonaspractical. Remember:

Step 6 Transport conditions

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

2 Youmustensureyoureceiveacopyofthe registrationdocumentfromtheharvesterwith eachbatch.

5 Don’tloadbatchesfromdifferentclassifications unlessyoucanguaranteePoint1.

6 Temperatureguide: (i) Mostbivalvestransportat2-5ºC. (ii) Musselscanbeicedorchilled. (iii)Nativeoystersandscallopsat4-8ºC.

1 Youmustkeepbatchesofbivalvesfrom differentareas (i) Separate. (ii) Identifiable. (iii)andpreventcross-contaminations.

Bulletpoint


1iii 853/2004,AnnexIII,SectionVII,ChapIIB1&B2

1i,b ii 853/2004AnnexIIISectionVII,Chapter1,3&4(a)(i-vi)and178/2004Article18

3 852/2004AnnexIIChapter4(7)&853/2004,AnnexIII,SectionVIIChapterIIB1(b)

4-6 -------------------

4-7

On

sho

reh

and

lingN

avigator

tool ste

ps:


4 Avoidroughhandling. Remember:

Step 7 Handling

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

4-7

On

sho

reh

and

ling

1 Youmustkeepbivalvesaliveandhandle themgently.

5 Checktemperatureconditions–neithertoohot ortoocold.

3 Youmust notsubjectthemtoextreme temperatures.

2 Youmust notre-immersetheminwaterthat couldcauseadditionalcontamination.

Bulletpoint


1-2 853/2004,AnnexIII,SectionVII,ChapIVB1(a)

2 853/2004,AnnexIII,SectionVII,ChapIVB.1(c)

3 853/2004,AnnexIII,SectionVII,ChapIVB.1(b)

4-5 -------------------

Navigato

r to

ol ste

ps:


Remember:

Step 8 Conditions for re-laying areas

Leg

al R

equi

rem

ents

Good

Pra

ctice

1 Bivalvesmustonlyberelayedinapproved areas–ClassificationAonly.

4 Usebuoysorpolesorotherfixedmeansto definerelayingareas.

3 Relayingareasmustbeseparatefromeach otherandfromanyproductionareas,to minimizepotentialcontamination.

2 Relayingareamustbeclearlydefined.

Bulletpoint


All 853/2004,AnnexIIISectionVIIChapII,C1

8-9

Re

layin

gN

avigator

tool ste

ps:


Remember:

Step 9 Handling for re-laying

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

Livebivalvemolluscsmust:

6 ThelocalEHOmustapproveandsuperviseany relayingactivity.

1 Behandledcarefully–toensurefilterfeeding activityresumesquickly.

3 Beseparateandidentifiablebybatch.

8-9

Re

layin

g

2 Beimmersedinseawaterforatleasttwo monthstoallowcorrectreductioninbacterial loadingunderthesupervisionoftheEHO.

4 Abatchofre-laidbivalvesmustberemoved (harvested)completely–allinallout.

5 Apermanentrecordofrelayedbivalvesmust bekept.

7 RefertoAppendix4:Recordkeeping.Bulletpoint


1 853/2004,AnnexIIISectionVIIChapII,C2(a)

2 853/2004,AnnexIIISectionVIIChapII,C2(c)

3 Regulation178/2002Article18

3-4 853/2004,AnnexIIISectionVIIChapII,C2(d)

5 853/2004,AnnexIIISectionVIIChapII,C3

Navigato

r to

ol ste

ps:


Remember:

Step 10 Preparation for dispatch – handling

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

6 Sprayshellswithcleanwatertoremovemud anddetritusifneeded.

1 Youmustavoidcontaminationormixingof batchesduringgrading,handling,sorting wrappingandpacking.

3 Youmustwashoffdirtanddetrituswithclean water.Donotimmerse.

2 Youmustkeepbivalvesaliveandin goodcondition.

Bulletpoint


1-2 853/2004AnnexIIISectionVIIChapterIVBand178/2002Article18

3 853/2004AnnexIIISectionVIIChapIVB2

4-6 -------------------

4 Keepcleanandhygienicworkpractices.

5 Bivalvesmustbehandledcarefully–keepthem alive,ingoodcondition,freefromdirtandin distinctbatches.

10-11

Disp

atch

Navigato

r to

ol ste

ps:


Step 11 Conditions for dispatch – origin

Leg

al R

equi

rem

ents

1 Bivalvesmustcomefromeither : (i) ClassAarea. (ii) Relayingarea(ClassA). (iii) Purificationcentre. (iv) Anotherdispatchcentre.

2 Ifyoudispatchlivebivalvesfromavessel,they mustcomefromClassAorrelayingareasand meettheEndProductStandard–referto Appendix3.

Bulletpoint


1 853/2004AnnexIII,SectionVII,ChapIV.B3

2 853/2004AnnexIIISectionVIIChapIVB4

10-11

Disp

atch

Navigato

r to

ol ste

ps:


1 Youmustpurifyalllivebivalveshellfishunless

theyare: (i) HarvestedfromClassificationAwaters. (ii) Sentforspecifiedheattreatmenttoan authorisedestablishment.

2 Youmustfollowtheofficialconditions ofapproval.

3 Purificationremoves‘low’levelofbacterial contaminationandgritfromlivebivalves.

Remember:

Bulletpoint


1 (i) 853/2004,AnnexIII,SectionVII,ChapIIA2&ChapterV

1 (ii) 853/2004,AnnexIII,SectionVII,ChapIIA5

2 ConsultyourNationalCompetentAuthority

3 -------------------

Step 12 Purification – general

Leg

al R

equi

rem

ents

Good

Pra

ctice

12-15

Pu

rifica

tion

Navigato

r to

ol ste

ps:


1 Sitemust notbesubjecttofloodingby

normalhightidesorrunoff.

2 Purificationtanksmustbe: (i) Internallysmoothandeasilycleaned. (ii) Capableofbeingcompletelyemptied–no residualwaterleftbehind. (iii) Positionedsothatwaterintakedoes not contaminatewatersupply. (iv) Suitableforvolumeandtypeofbivalves beingpurified,topreventstressanddamage.

Bulletpoint


1 853/2004,AnnexIII,SectionVII,ChapIII.1

2 (i-iii) 853/2004,AnnexIII,SectionVII,ChapIII.2(a-c)

2 (iv) 853/2004,AnnexIII,SectionVII,ChapIII.3

Step 13 Purification – structural hygiene

Leg

al R

equi

rem

ents

12-15

Pu

rifica

tion

Navigato

r to

ol ste

ps:


1 Beforeloading–washbivalvesfreeofdirt,silt,

anddebriswithcleanuncontaminatedwater.

2 Youmustloadonlyonetypeofbivalve shellfishinatank.

3 Youmust notoverloadtanks.

6 Bivalveshavetobealive–checkanddiscardany dead,gapinganddamagedshells.

Remember:

7 Nodeadanimals,‘duds’oremptyshellsshould

gointhepurificationtanks.Theycanholdmud ballsandcontaminatethebatch.

8 Weadviseagainstplacingseaweedinthetanks.

4 Fordifferentbatchesofthesamespecies, purificationtimemustbebasedonthebatch requiringthelongestperiodofpurification.

5 Youmust notplaceanyotherfishoranimalin thetankwithbivalvesthatarebeingpurified.

Bulletpoint


1 853/2004,AnnexIII,SectionVII,ChapIVA.1



4 853/2004,AnnexIII,SectionVII,ChapIVA4

5 853/2004,AnnexIII,SectionVII,ChapIVA4&A6

6 - 8 -------------------

Step 14 Purification – loading tanks

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

9 Youmustbeabletoidentifytheoriginofall

batchesthataremixed.

12-15

Pu

rifica

tion

Navigato

r to

ol ste

ps:


Bulletpoint


1-2 853/2004,AnnexIII,SectionVII,ChapIVA.3


4-7 -------------------

1 Youmustpurifyforcorrecttime.

2 LivebivalvesmustmeettheEndProduct Standard(Appendix3).

3 Alldispatchesofpurifiedbivalvesmustbe labelledtoshowpurificationhasbeen carriedout.

Remember:

5 Keepbivalvessubmergedatalltimes.

6 Checkthatshellsareopenandbivalvesare

filterfeedingnormally.

Step 15 Purification – operation checks

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

7 Draintankscompletelybeforeremoving

bivalvestoavoidre-contaminatingthem.

12-15

Pu

rifica

tion

4 Checkwatertemperature,waterflowrateand salinityaresuitableforthespecificspeciesbeing purified.Thisallowsnormalfilterfeedingactivity totakeplace.

Navigato

r to

ol ste

ps:


1 OperatorsshouldestablishaHACCP–

HazardAnalysisCriticalControlPointSystemat theirpremises.

2 Youarerequiredtofollowyourcompany’s HACCPsystemtoprotectthefoodsafetyof bivalveshellfishforhumanconsumption.

16-19

Pu

rifica

tion

- HA

CC

P

5 Filloutandmaintainrecordscarefully andcorrectly.

Remember:

3 Youremployermustprovideyouwith adequatetraining.

4 Youmustabidebystaffhygieneand dressprocedures.

Step 16 Purification centre – HACCP systems

Leg

al R

equi

rem

ents

Good

Pra

ctice

Bulletpoint


1-2 852/2004,Chap1,Article1(a)&(d)&Article5FoodSafetyActofGreatBritain,1990

3 852/2004AnnexIPartAII4(e)

4 852/2004AnnexIIChapterVIII1&2

5 -------------------

Navigato

r to

ol ste

ps:


1 Youmustknowwherethebivalveshellfish

originated–youmusthaveaGatherers RegistrationDocument.

2 Youmustwashshellfishwithcleanwater beforeloadingintotanks.

16-19

Pu

rifica

tion

- HA

CC

P

3 Don’tallowcontaminationbetweenbatches.

5 TheremaybeotherControlMeasuresnot listedherewhichmaybeimportantto youroperation.

Remember:

4 Discarddead,dyingordamagedbivalves.

Examples of Control Measures when receiving raw material:

Bulletpoint


All 852/2004,ChapIIArticle5


Poss

ible

Cri

tica

l Co

ntro

lsGoo

d Pr

actice

Navigato

r to

ol ste

ps:


1 Followpurificationoperatingandapproval

conditionsissuedbytheEHOandadviseissued bySeafish.

2 Donotoverfilltanks–makesureallshellfish areimmersed.

16-19

Pu

rifica

tion

- HA

CC

P

3 Donot‘bag’theanimalspriortopurification.

8 Animalsshouldnotbepreventedfromopening theirshells/siphonsfully.

Remember:

4 Checktemperature,salinityandflowrateare suitableforshellfish.

5 CheckUVsystemisoperationalandthequartz sleeveiscleanedonaregularbasis.

Bulletpoint


All 852/2004,ChapIIArticle5

Examples of Control Measures when operating purification systems:

6 Purifyforcorrecttimeandcheckbivalvesregularly.

7 Draintanksslowlyandcompletelyandthen removebivalvescarefully.


9 TheremaybeotherControlMeasuresnotlisted herewhichmaybeimportanttoyouroperation.

Poss

ible

Cri

tica

l Co

ntro

lsG

oo

d P

ract

ice

Navigato

r to

ol ste

ps:


1 Makesuregrading,sortingandde-bearding

equipmentiscleanandfreefromany previousbatches.

2 Useclean,uncontaminatedwater.

16-19

Pu

rifica

tion

- HA

CC

P

3 Useclean,approvedpackagingmaterials.

8 TheremaybeotherControlMeasuresnotlisted herewhichmaybeimportanttoyouroperation.

Remember:

4 Labelpacksandbagscorrectlyandsecurely.

5 Useclean,uncontaminatedwaterforre-watering orimmersedstorage.

Bulletpoint


All 852/2004,ChapIIArticle5;

Examples of Control Measures when packing and distributing:

6 Storeofftheground.

7 Useappropriatetransportthatisclean,hygienic andmaintainsthecorrecttransporttemperature.


Poss

ible

Cri

tica

l Co

ntro

lsGo

od P

racti

ce

Navigato

r to

ol ste

ps:


1 Bivalves mustbehandledcarefully–keep

themaliveandingoodcondition.

2 Oystersandscallopsmustbewrappedor packagedwithconcaveshelldownwards.

3 Wrappingandpackagingmust not contaminatebivalves.

6 Don’tusedamaged,soiledornon-approved packaging.

Remember:

4 Retailpacksofbivalvesmustbeclosed,and remaincloseduntilsold.

5 Afterpackaging,bivalvesmust notbe re-immersed,sprayedorplacedincontactwith waterincludingmeltwaterfromice.

Step 20 Wrapping and packing

Leg

al R

equi

rem

ents

Good

Pract

ice

20

-21W

rap

pin

g a

nd

Pack

ing

Bulletpoint


1 853/2004,AnnexIII,SectionVII,ChapIV.B1

2 853/2004,AnnexIII,SectionVII,ChapVI.1

3 852/2004AnnexIIChapX1-2

4 853/2004,AnnexIII,SectionVII,ChapVI2

5 853/2004,AnnexIII,SectionVII,ChapVIII.2

6 -------------------

Navigato

r to

ol ste

ps:


1 Labels,includingtheIdentificationMark(Health

Mark)mustbewaterproof.

2 Labelsmustincludespeciesname–common andscientificnames.

3 Labelmustincludedateofpacking–dayand monthminimum.

6 Theretailermustkeepthelabelfrom non-consumerreadypacksfor60days.

Take note:

4 Labelmustbelegible,permanentand clearlydisplayed.

5 Labelmustincludetheapprovalnumberofthe processingfacility–officialovalstyle.

Step 21 Labelling for market

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

20

-21W

rap

pin

g a

nd

Pack

ing

Bulletpoint


1 853/2004,AnnexIII,SectionVII,ChapVII1

2 853/2004,AnnexIII,SectionVII,ChapVII2(a)

3 853/2004,AnnexIII,SectionVII,ChapVII2(b)

4 853/2004,AnnexII,SectionIB5

5 853/2004,AnnexII,SectionIB7&B8

6 853/2004,AnnexIII,SectionVII,ChapVII3

7 -------------------

7 Foodapproveddye/inkshouldbeusedonlabels.

Navigato

r to

ol ste

ps:


1 Storebivalvesatthecorrecttemperatureto

keepthemaliveandingoodcondition.

2 Livebivalvemolluscsmust havenormal amountsofintra-valvularliquidandshowan adequateresponsetoapercussivetap.

3 Storebivalvesincoolconditions.

Remember:

Step 22 Storage of bivalves

Leg

al R

equi

rem

ents

Go

od

Pra

ctic

e

Bulletpoint


1 853/2004AnnexIIISectionVIIChapVIII1

2 853/2004AnnexIIISectionVIIChapV1

3-7 -------------------

4 Avoidextremetemperatureregimes.

22

-24

Sto

rag

e a

nd

disp

atch

5 Livemusselscanbestoredonice.

6 Storethemoffthegroundtoavoidcontamination.

7 Keepstoragetimesasshortaspractical–bivalves mustbedeliveredtothecustomeralive.

Navigato

r to

ol ste

ps:


1 Youmustkeeptransportcontainerscleanand

ingoodrepair.

2 Youmust notsubjectlivebivalveshellfishto extremesoftemperatureduringtransport.

3 Thetransportholdmustbe: (i) Cleanandcorrosionfree. (ii) Coveredtoprotectfromexcesswind,rain andsun. (iii)Beloadedsuchthatthereisnoriskofcross contaminationbetweendifferentproducts.

Remember:

Step 23 Product dispatch

Lega

l Req

uire

men

tsG

oo

d P

ract

ice

Bulletpoint


1 852/2004AnnexIIChapIV1

2 853/2004,AnnexIII,SectionVII,ChapVIII.1

3(i-iii) -------------------

22

-24

Sto

rag

e a

nd

disp

atch

Navigato

r to

ol ste

ps:


1 TheoriginalIdentificationMark(healthmark)

mustbekept.

2 Recordsoftheoriginanddispatchmust bekept.

Step 24 Handling after dispatch

Lega

l Req

uire

men

ts

Bulletpoint


1 853/2004,AnnexIII,SectionVII,ChapVII.3

2-3 853/2004AnnexIISectionIA4&178/2002Article18

3-4 853/2004AnnexIISectionIA2

22

-24

Sto

rag

e a

nd

disp

atch

If bivalve consignments are split before reaching the final consumer:

3 Don’tmixlivebivalvesfromdifferentdispatch

centreswhenre-packed.

4 AnewIdentificationMark(HealthMark)must

beattachedwhenre-packed.

Navigato

r to

ol ste

ps:


Appendix 1: Classification of bivalve shellfish waters

Ap

pe

nd

ices

•Bivalvesmustonlybeobtainedfromdefinedclassifiedareasandtreatedaccordingly.

•Class A – mustmeetrequirementsforfoodqualitybivalvesfordirectsaleforhumanconsumption.

•Amaximumlimitof230colonyformingunitsofEscherichia coliin100goffleshandintra-valvularliquid.

•Class B – must bepurifiedbeforesellingaslivebivalvemolluscs.

•Amaximumlimitof4,600colonyformingunitsofE.coliin100goffleshandintra-valvularliquid.

•Class C – must berelayedindesignated‘relayingsites’foratleasttwomonths,thenpurifiedifrequiredorsubjectedtoheattreatment.

•Amaximumlimitof46,000colonyformingunitsofE.coliin100goffleshandintra-valvularliquid.

Navigato

r to

ol ste

ps:


Bulletpoint


All 854/2004AnnexIIChapIIA1-5RefertorelevantCompetentAuthority

Appendix 2: Bivalve shellfish biotoxin limits

Ap

pe

nd

ices

Limits for toxins after which bivalves cannot be sold for human consumption

•PSP (Paralytic Shellfish Poison): 800microgramsperkilogram.

•ASP (Amnesic Shellfish Poison): 20milligramsofdomoicacidperkilogram.

For DSP

•For okadaic acid, dinophysistoxins and pectenotoxins together:

160microgramsokadaicacidequivalentsperkilogram.

•Yessotoxins: 1milligramequivalentperkilogram.

•Azaspiracids: 160microgramsofazaspiracidequivalents perkilogram.

Navigato

r to

ol ste

ps:


Bulletpoint


All 853/2004,AnnexIII,SectionVII,ChapV.2(a-e)

Appendix 3: Product standard for live bivalve shellfish

Bulletpoint


1 854/2004AnnexIIChapIIA3

1-2 2073/2005AnnexIChap1.17&1.24

3-5 853/2004AnnexIIISectionVIIChapV1

6 853/2004AnnexIIISectionVIIChapV2(a-e) Ap

pe

nd

ices

1Lessthan230colonyformingunitsofEscherichia. coliin100goffleshand intra-valvularliquid.

2 Must notcontainSalmonella bacteriain25gofflesh.

3Bealive,freshandingoodcondition.

4Normalamountsofintra-valvularliquidatsaleandadequateresponsetopercussivetap.

5 Musttastefresh,nooff-flavoursandbefreeofdetritus.

6 Must notcontainmarinebiotoxinsinexcessofthosestatedinAppendix 2.

Navigato

r to

ol ste

ps:


Appendix 4: Record keeping – general

Bulletpoint


1 853/2004,AnnexIIISectionVIIChapII,C3

2-3 853/2004,AnnexIII,SectionVII,ChapI.3-7

4 852/2004AnnexIPartB2(j)

5 852/2004Article5(g)&AnnexIAIII7

6 178/2002Article181-5 Ap

pe

nd

ices

1Allfoodbusinessestablishmentsmustkeepandretainrecordsrelatingtothesafetyandlegalityofproductsandmakethemavailableonrequesttothecompetentauthorities.

2Specifically,aRegistrationDocumentmustbecompletedforeverybatchoflivebivalveshellfish.

3Acopyofthedocumentmustbekeptfor12months.

4Recordsrelatingtothehygieneconditionsoftheoperationshouldbekepttodemonstratecompliancewithlegalobligations.

5Purificationcentresmustkeeprecordsofthepermanentmanagementproceduresforthecontrolandeliminationofhazardstothesafetyoflivebivalveshellfish.

6Supplier,productionanddistributionrecordsmustbekepttoensurethetraceabilityandifrequiredtherecallofgoodsaccordingtotherequirementsof178/2002.

Navigato

r to

ol ste

ps:


Appendix 5: Record keeping – registration document

Bulletpoint


All 853/2004,AnnexIII,SectionVII,ChapI.3-7 Ap

pe

nd

ices

1 TheGatherersRegistrationDocumentmustinclude: (i) Gatherer’sidentityandaddress (ii) Dateofharvesting (iii) Locationofproductionarea (iv) Healthstatusofproduction/harvesting area–classification‘A’,‘B’or‘C’

(v) Bivalvespeciesandquantity (vi) Batchdestination (vii) Biotoxinstatusoftheprecisearea.

2 Forrelayedbivalves: (i) Relayingperiod(ifapplicable) (ii) Relayingarea(ifapplicable) (iii) Destinationofthelivebivalvemolluscs (iv) Biotoxinstatusoftheprecisearea.

3 Forpurifiedbivalves: (i) Theaddressofthepurificationcentre (ii) Durationofpurification (iii) Datesofentryandleavingpurificationcentre.

4Onreceivingabatchofbivalves,thedocumentmustbedatestampedorthedaterecordedinanothermanner.

5 Acopyofthedocumentmustbekeptforatleast12months.

6 Gatherer’sdocumentmustbereadableandunaltered.

N.B.Incertaincasesa‘PermanentTransportAuthorisation’maybegrantedifthegathererandreceiverarethesamelegalentity.

Navigato

r to

ol ste

ps:


Appendix 6: The european hygiene regulations

Ap

pe

nd

ices

TheEuropeanCommissionhasintroducedRegulationstoreplaceexistingnationalfoodlawinMemberStates.PreviousfoodlaworiginatingfromtheCommissionallowedMemberStatestomakenationallawstobringEuropeanlawintoforcewhichledtodifferencesinnationallawsbetweenmemberstates.

Since1January2006TheEuropeanHygieneRegulationshavereplacedthefollowingGeneralFoodHygieneandFisheryProductregulations:

TheFoodSafety(GeneralFoodHygiene)regulations1995.TheFoodSafety(FisheryProductsandLiveShellfish)(Hygiene)regulations1998.

Inadditionsince1January2005EuropeanRegulation178/2002layingdownthegeneralprinciplesoffoodlawhasmadesomechangestotheresponsibilitiesoffoodbusinesses.AnobjectiveofthenewrulescontainedintheHygieneRegulationsistosimplifytheapplicationofhygienelawacrosstheEuropeanUniontofacilitatethefreemovementandtradeoffoodproductswithintheCommunity.Amajorchangetothedefinitionoffoodisthatitwillnowinclude‘primaryproduction’andfoodsold’live’andthereforeincludestheplacinginthemarketplaceoflivebivalveshellfish.

New Rules on the Production of Safe food:

Regulation178/2002/EClayingdownthegeneralprinciplesoffoodlaw,establishingtheEuropeanfoodsafetyAuthorityandlayingdownproceduresinmattersoffoodsafety.Thispieceoflegislationcontainsprovisionstoensuresafefoodandfeedincludingtraceabilityandproductrecall.

Regulation852/2004/EConthehygieneoffoodstuffs.Thiscontainsthebasisrequirementsapplicabletoallfoodbusinesses.Itrequiresfoodbusinessoperatorstoconsidertheriskstofoodsafetyintheirbusinessandsetacceptablelimitsforanyrisks.

Regulation853/2004/EClayingdownspecifichygienerulesforfoodofanimalorigin.Thiscontainstheadditionalmoreprescriptiveprovisionsfordifferentcategoriesoffood.AnnexIIISectionVIIcontainsthespecificrulesonlivebivalvemolluscs.

Regulation854/204/EClayingdownspecificrulesontheorganisationofofficialcontrolsonproductsofanimaloriginintendedforhumanconsumption.ThesecontaintheprovisionsforofficialcontrolsofproductsofanimaloriginandprescribetheenforcementprocedurestobecarriedoutbycompetentauthoritiesinrespecttoRegulation853/2004/EC.

Regulation2073/2005MicrobiologicalCriteriaforFoodstuffs.Thissetsacceptablemicrobiologicallimitsforallfoodsincludinglivebivalveshellfish.

Navigato

r to

ol ste

ps:


Acknowledgements:Seafishwouldliketoacknowledgethecontributionsfromthefollowingorganisationsthatwereconsultedduringthedraftingofthisdocument:

MikeGlavin: FSA

SusanneBoyd:FSANI

RonLee:CEFAS

CliveAskew:SAGB

ChrisLeftwich:Billingsgate Fish Market

DouglasMcLeod:ASSG

MylesBloodSmyth:Exmouth Mussels Ltd.

LornaMurray:FSA (Scotland)

LizTurrell:Fisheries Research Services, Aberdeen

JeremyPercy:SWWFC

MichaelLaurenson:Blue Shell Mussels Ltd.

WalterSpiers:Muckairn Mussels Ltd.

SueDibb:National Consumer Council

JoMcDonald:British Retail Consortium

BrianDaly:DARDNI

SandyMcAllister :McAllister Shellfish Ltd.

DavidAttwood:Loch Fyne Oysters

CallumMacMillan:Hebridean Oysters

DavidHughJones

Bigbury Bay Oysters

SouWest Seafoods

DavidSkea

ShaunKrijnen

Navigato

r to

ol ste

ps:


SeafishSeafishHouse,StAndrew’sDock,HullHU34QET:01482327837F:01482223310E:[email protected]

Good manufacturing practice guidelines Live bivalves workbook

Documents

Transcript of Good manufacturing practice guidelines Live bivalves workbook