eu food law

BUILDINGCAPACITYOFSME’sONEUFOOD&PACKAGINGSTANDARDS

EULegisla<on

Principles & Requirements of Food Law

Thessaloniki11.06.2012

1EUIns4tu4ons

2EUFoodLaw3Na4onalLegisla4on&

Standards

EUIns<tu<ons&policymaking

Κανονισμός1169/2011

1

Coun

cilofthe

EU

• RepresentstheGovernmentsofM-S

• Presidencyissharedonarota<ngbasis

• MinisterofHealth

• MinisterofAgriculture

Commission • RepresentsEU

interestsasawhole

• CommissionersappointedbyM-S

• DGSANCO• DGAGRI

Parliam

ent • RepresentsEU

ci<zens• Directlyelectedbyci<zens

• ENVIcommi>ee

FundamentalEUIns4tu4ons&PolicyMaking

•  1992–MaastrichtTreaty:Co-decisionprocedure•  2009–LisbonTreaty:renames“co-decision”as“TheOrdinaryLegisla<ve

Procedure”

TheOrdinaryLegisla4veProcedure

1.Rightofini<a<ve2.AutonomousPromo<onofthecommunityinterest

Directrepresenta<onofEUci<zens

Nego<a<onsofna4onalinterests

Commission

CounciloftheEU EUParliament

THEEUDECISIONMAKINGPROCESS

OrdinaryLegisla4veProcedureataglance

Approvesa“joint”text

2Readingsfordiscussion&considera<on

Agreementà Concilia<onCommi[ee

ProposalbyCommissionsentto

Parliament Council•  The Commission sends its proposal to

ParliamentandtheCouncil.•  They consider it, and discuss it on two

successiveoccasions.•  A]er two readings, if they cannot agree, the

proposal is brought before a Concilia<onCommi[ee made up of an equal number ofrepresenta<vesoftheCouncilandParliament.

•  Representa<vesoftheCommissionalsoa[endthe mee<ngs of the Concilia<on Commi[eeandcontributetothediscussions.

•  WhentheCommi[eehasreachedagreement,thetextagreeduponissenttoParliamentandtheCouncilforathirdreading,sothattheycanfinallyadoptitasalegisla<vetext.

•  The final agreement of the two ins<tu<ons isessen<alifthetextistobeadoptedasalaw.

•  EvenifajointtextisagreedbytheConcilia<onCommi[ee, Parliament can s<ll reject theproposedlawbyamajorityofthevotescast.

EUFoodLaw&DecisionMaking

DGSANCOorDGAGRI

MinistersofHealth

orAgriculture

ENVICommi[ee

EUFoodLaw&DecisionMaking

Opinion

EFSA

Legisla<veActs

Council Commission Parliament Member-State

EULegisla<on

• Regula<on• Direc<ve• Decision

Legisla4veActs:EU

Legisla4veActs:EUvsNa4onalActs

•  Regula<on– Bindinglegisla<veact– Mandatoryinitsen<retyacrosstheEU

•  Direc<ve– setsoutagoalthatallEUcountriesmustachieve– M-Sdecidehow– Mustbetransposedtona<onallegisla<on

•  Decision– Bindingtowhomitisaddressed(e.g.aM-Soracompany)

•  EFSA’sNa<onalFocalPoint•  Representa<onofGreeceat

–  EFSAAdvisoryForum–  EFSAworkinggrouponcommunica<ons– WorkinggroupsandStandingCommi[eesofDGSANCO&EUCouncil

–  Labelling–  Nutri<on&Healthclaims–  OfficialControl,etc

•  Coordina<onofna<onalposi<ons•  Na<onalContactpointforRASFF•  MemberofBTFSF(Be[erTrainingForSaferFoods)network

EFET&EUIns4tu4ons

2 EUFoodLaw

Anoverviewofbasicrequirements

Theevolu<onofthecurrentEUFoodLawframework

FundamentalsofEUFoodLaw

Timeline….

• Re-engineeringofEUFoodSafetyBodies

1996-97BSECrisis–Madcows

disease

• IntegratedapproachonFoodSafety

• Fromfarmtofork• Fromstabletotable

2000TheWhitePaperon

FoodSafety • Obliga<onsofFBOs• GeneralprinciplesofFoodLaw

• EstablishmentofEFSA

2002Regula<on178/2002

• General&specificissuesoffoodhygiene

• TheEUsystemforofficialcontrol

2004TheHygienePackage

Timeline….

…thisisnottheend…

• Regula<on2073/2005Microbiologicalcriteriaforfoodsafety&

hygienemonitoring

• Regula<on2074/2005Implemen<ngmeasuresforcertain

productsundertheprovisionsofReg853/2004

• Regula<on931/2011Traceabilityrequirements

TheEUFoodLawataglance

Generalprovisions

•  Officialcontrols•  Hygiene• Microbiologicalcriteria•  Addi<ves&Contaminants•  FoodContactMaterials•  GMOs•  FoodInforma<ontoConsumer•  PARNUTS

Specificrules(notsafetyissuesbutstandards)

•  Health&nutri<onclaims• Milk•  Chocolate•  Juices•  Eggs•  Honey

WhitePaperonFoodSafety–Targets

High level of human health &c o n s u m e r p r o t e c 4 o n a n dmaintenance of a strict food safetystandard

A food safety policy based on anintegrated&comprehensiveapproach

Coherent,dynamiclegalframework

Broad body of legisla<on in primaryproduc<onandprocessed foodsBUTwith NO COHERENCE – Need forreview

Regula<on178/2002


WhitePaperonFoodSafety–TheStrategy

•  The3stepstoreachthetarget

–  EstablishmentofEFSA

–  Integratedapproachwithinthewholefoodchain•  Fromfarmtofork

•  Fromstabletotable

–  Setupofthefollowingprinciples•  FBOhasthemainresponsibilityforfoodsafety

•  Na<onalAuthori<esmustestablishofficialcontrolsystemstoinspecttheabilityofFBconcerningfoodsafety

•  EUmustauditthecompetencyofNa<onalAuthori<es

Regula<on178/2002

•  Thefundamentallegaltextonfoodsafety

– establishesthecommonbasisforfoodlawinall

M-S

– providestheframeworkforthedevelopmentof

EUfoodlawwhichincludes‘thehygiene

package’

Regula<on178/2002–Outline

•  Objec<ve–  toensureahighlevelofprotec<onforhumanhealthandconsumers'interestinrela<ontofood

•  Basicprinciple–  theprimaryresponsibilityforensuringcompliancewithfoodlaw,restswiththefoodbusinessoperator(FBO)

•  Keypoints

–  Integratedapproachforfoodsafety

–  Riskanalysisprocedure

–  Theprecau<onaryprinciple

–  Traceabilitysystems

–  Crisismanagement

–  Theneedfortransparencyindecisionmaking

–  TheestablishmentofEFSA

–  Imports–exportsequivalence

–  Therightofconsumerforaccurateinforma<on

Regula<on178/2002–Keyobliga<onsofFBOs

SafetyFBOsshallnotplaceonthemarketunsafefood

ResponsibilityFBOsareresponsibleforthesafetyofthefoodwhichtheyproduce,transport,storeorsell

TraceabilityFBOs shall be able to rapidlyiden<fyanysupplierorowner

TransparencyFBOsshallimmediatelyinformthecompetentauthori<esiftheyhaveareasontobelievethattheirfoodisnotsafe

EmergencyFBOs shall immediatelywithdrawfoodfromthemarketiftheyhavea reason to believe that it is notsafe

Preven4onFBOs shall iden<fy and regularlyreviewthecri<calpointsintheirprocessesandensurethatcontrolsareappliedatthesepoints

Traceability

•  Means the ability to trace and follow a food, at allstagesofproduc<on

•  Traceabilityfacilitatestheiden<ty,historyandsourceofaproduct

–  Itdoesnotmakefoodsafe,itisamanagementtool

–  Itenablestheassuranceoffoodsafetyandallowsac<ontobetakeniffoodisfoundnottobesafe,e.g.withdrawalorrecall

Traceability–The“oneup”/”onedown”concept

•  Eachstageinthefoodchainmust

–  Iden<fywhatisreceived(rawmaterialsfromthepreviousstageinthechain)

–  Iden<fywhereproductissent(tothenextstageinthechain)

–  Makeinforma<onavailableondemand

•  Eachstageinthefoodchainisresponsiblefortheopera<onsundertheircontrol

–  Norequirementforwholechaintraceability

Traceability–The“oneup”/”onedown”concept

Rawmaterialsorproductsfromsupplier

• Onestepdown

Opera<on

• Storage• Transport• Manufacture

Productstocustomer

• Onestepup

Astageinthefoodchain

Makeinforma4onavailableondemand

Traceability–Industrystandards&prac4ce•Oneup/onedownconceptpluslinkfinishedproductto/fromrawmaterials•Eachfoodbusinessopera<onmustbeabletotraceandfollow–Allrawmaterialsfromsource–Throughallstagesofproduc<on–Todistribu<onofthefinishedproduct•Traceabilityisestablishedfromrawmaterialtofinishedproductandvisaversa

• Iden<fywhatisreceivedfromwhere

Rawmaterials

• Iden<fywhatisproducedfromwhat,when,how

Opera4on• Iden<fywhereproductissent

Products

Componentsofatraceabilitysystem

Organise&plantraceability

Implementa<onoftraceability

Verifythatthesystemisworkingeffec<vely

Establishdocumenta<onandrecordkeeping

Traceability–Regula<on931/2011

•  Fromthe1stJuly2012,theprovisionssetoutinRegula<on931/2011regardingthetraceabilityrequirementsforunprocessedorprocessedfoodofanimaloriginwillbeapplicable.

–  Setsthepieceofinforma<ontheFBOshouldprovidetothecompetentauthorityuponrequest

•  anaccuratedescrip5onofthefood•  thevolumeorquan5tyofthefood

•  thenameandaddressofthefoodbusinessoperatorfromwhichthefoodhasbeendispatched

•  ……..

•  areferenceiden5fyingthelot,batchorconsignment,asappropriate

Reg178/2002-Theprecau<onaryprinciple

In specified circumstances where, following an

assessment of available informa<on, the possibility of

harmful effects on health is iden<fied but scien<fic

uncertainty persists, provisional risk management

measures necessary to ensure the high level of health

protec<on may be adopted, pending further scien<fic

informa<onforamorecomprehensiveriskassessment

TheHygienePack


HygienePack

•  Itisthecurrentregimeofhygienerules

•  iso]enreferredtoas‘Thehygienepackage’

•  itaimstointroduceconsistencyandclarity

throughoutthefoodproduc<onchainfrom

'farmtofork'.

HygienePack

• HygieneoffoodstuffsRegula<on852/2004

• SpecificHygieneRulesforFoodofAnimalOriginRegula<on853/2004

• MicrobiologicalcriteriaforfoodstuffsRegula<on2073/2005

• Implemen<ngmeasuresRegula<on2074/2005

• Fortheimplementa<onofregula<ons852/2004,853/2004andforofficialcontrolNa<onalrules

The‘hygienepackage’iscomprisedofrulesonthefollowing:

Regula<on852/2004

•  Basicobliga<on

– FBOstoensurethatallstagesofproduc<on,

processinganddistribu<onoffoodundertheir

controlsa<sfytherelevanthygienerequirements

laiddowninRegula<on852/2004

Regula<on852/2004&HACCPrequirements

•  AllFBOs(produc<on,processinganddistribu<onoffood)mustputinplace,implementandmaintainapermanentprocedureorproceduresbasedontheHACCPprinciples.

•  Foodbusinessoperatorsmust:

–  providethecompetentauthoritywithevidenceoftheircompliancewiththerequirementtohaveproceduresbasedontheHACCPprinciplestakingaccountofthenatureandsizeofthefoodbusiness

–  ensurethatanydocumentsdescribingtheproceduresdevelopedinaccordancewiththisareup-to-dateatall<mes

–  retainanyotherdocumentsandrecordsforanappropriateperiod

Regula<on852/2004&HACCPrequirements

•  Forbusinessesundertakinglowriskac<vi<estheprerequisitehygienerequirements(AppII

ofReg852/2004)aresufficient

– NoneedforestablishmentofaHACCP-based

procedure(butitisdesired)

– Guidancedocumentforimplementa<onofHACCP

Regula<on852/2004andrequirements

•  FoodBusinessesmustcomplywiththestandardslaiddowninAppIIofRegula<on852/2004

–  ChapterI:Generalrequirementsforfoodpremises

–  ChapterII:Specificrequirementsinroomswherefoodstuffsareprepared,treatedorprocessed

–  ChapterIII:Requirementsformovableand/ortemporarypremises

–  ChapterIV:Transport-Containersusedfortranspor<ngfoodstuffs

–  ChapterV:Equipmentwithwhichfoodcomesintocontact

–  ChapterVI:Foodwaste

–  ChapterVII:Watersupply

–  ChapterVIII:PersonalHygiene

–  ChapterIX:Provisionsapplicabletofoodstuffs

–  ChapterX:Provisionsapplicabletothewrappingandpackagingoffoodstuffs

–  ChapterXI:Heattreatment

–  ChapterXII:StaffTraining

Regula<on853/2004

•  Laysdownmorespecifichygienerequirementsforfoodsof

animalorigin

•  Otherissues–  Registra<onorapprovalofestablishments

–  Healthandiden<fica<onmarking

–  Importofproductsofanimalorigin

Regula<on2073/2005–Microbiologicalcriteria

•  Foodbusinessoperatorsshall:–  Testagainstthevaluessetforthecriteria-takesamples–  Conductstudiesinordertoinves<gatecompliancewiththecriteria

throughouttheshelf-life–  Implementcorrec4veac4ons-HACCPplan,foodlawand/ortheinstruc<ons

givenbythecompetentauthority–  Takemeasurestofindthecauseofanunsa4sfactoryresultinorderto

preventthereoccurrenceofunacceptablemicrobiologicalcontamina<on

•  Microbiologicalanalysisisdoneforverifica<onpurposes,ietocheckthateverythingwasdoneinsuchawaytoobtainasafeproduct

Regula<on2073/2005–Microbiologicalcriteria

•  Foodsafetycriterion–  alimitabovewhichafoodstuffshouldbeconsideredunacceptably

contaminated

–  Itappliestoproductsplacedonthemarket

–  Salmonella,Listeria,etc

•  Processhygienecriterion–  alimitindica<ngtheacceptablefunc<oningofaproduc<onprocess.

–  Suchacriterionisnotapplicabletoproductsplacedonthemarket.

–  Itsetsanindica<vecontamina<onvalueabovewhichcorrec<veac<onsare

required

–  E.coli,Coliforms,etc

3 Na4onalandother

Interna4onalStandards

Na<onalLegisla<on

•  TransposeEUDirec<ves•  Setupofna<onalimplemen<ngmeasures•  Specificna<onalstandards

–  Food&Drinkcode•  Anynewna<onallegalactmustbeno<fiedtotheEUins<tu<ons(TRISSystem)beforeadopted

CodexAlimentarius

•  Interna<onalbodysetupin1961asasubsidiarybodyofFAOandtheWHO

•  Mainscope–  todevelopandadoptaseriesoffoodstandardsandrelatedtextsthataimtoprotectthehealthofconsumersandensurefairprac<cesintheinterna<onalfoodtrade.

•  Notalegalrequirement–  EUhassome<messtricterspecifica<ons