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Capacity building of the competent authorities for food safety, veterinary and phytosanitary policy EuropeAid/132281/D/SER/MK. Training course. Lecturer: MVDr. Josef Holejšovský PhD. Place: Skopie , FYROM Date: 18 - 22 M ay 201 5.
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Capacity building of the competent authorities for food safety, veterinary and phytosanitary policy EuropeAid/132281/D/SER/MK Training course Lecturer:MVDr. Josef Holejšovský PhD Place: Skopie, FYROM Date: 18-22 May 2015
Capacity building of the competent authorities for food safety, veterinary and phytosanitary policy EuropeAid/132281/D/SER/MK Content: Title A: Overview of EU legislation on AnimalHealth
History and DevelopmentofEU Veterinary Legislation • 1. In 1957 the Rome Treaty signed and the EEC created • 2.Common Agricultural Policy (CAP)became the most important issue regarding the food supplyindependence • 3.Differences in veterinary policy caused • by different animal health status • 4.Different veterinary policy – obstacles • for free movement i.e. for single market • of animals and animal's origin product.
History and DevelopmentofEU Veterinary Legislation 5. In 1964 first veterinary directives adopted- Council Directives 64/432 and 64/433/EEC laingdown requirements concerning animal healths and and food safety for intracommunity trade (placing on the community market). 6. In 1972 further directive adopted i.e. CD 72/462/EEC covering the same areas while trading with third countries
History and DevelopmentofEU Veterinary Legislation 7. In 1987 – European Single Market Act- the most productive period as fortheVeterinarylegislationbegan. 8. In 1988 StrategicDocument– basisforpreparationofveterinarylegislationleadingtowards full harmonisationtillthe end of 1992 (MastrichtTreaty on EU) .
History and DevelopmentofEU Veterinary Legislation MainPointsofStrategicDocument: • full harmonizationofveterinarylegislatonoverthewholeterritoryofEU MemberStates • thesame status as forthe animal and public health in all MS athighestlevelpossible • clasificationofdiseasesin compliancewiththeirimportancefor animal and humanhealth • newsystemeofcontrol and supervision • newhealthsafetydefinition- principleofregionalization
Institutions of the European UnionInvolved in Legal Process The Council of the European Union represents the EU member states The European Parliament represents the EU citizens The European Commission represents the EUas a whole
The EU Legislative Process . • Initiative • Consultation • Decision making EuropeanParliament Council of Ministers EuropeanCommission
Legal Acts • Regulation -directly applicable and binding on all MemberStates (MS) • Directive- transposedin to thenationallegislation. MS must adopt national measuresto meet its objectives (to achievethesameeffect) • Decisions- binding on those to whom it is addressed
Developpement of the New EU Food Legislation From Green Paper towards the Food Law • Green Paper – 1997 • Presents Food Safety Issues to Citizens and Institutions for public discussion • White Paper on Food Safety - 2000 • Defined Food Safety Policy and its Principles based on Discussion Results iniciated by Green Paper • General Foodlaw (2002) – Regulation (EC) 178/2002 • Lays down leagally Food Safety Poicy Principles and • establishes EFSA - European Food Safety Authority – EFSA carries out risk assesment and risk analysis on scientific basis
EU Vet PH and Food Legislation • General Food Law 178/2002/EC • Hygiene Package 852(General principles) and 853 (Food of animal origin)/2004/EC • OfficalFeed and Food Controls and Auditss854/2004/EC, 882/2004/EC
Risk analysis as main principle The Components of Risk Analysis Risk Assessment Scientifically Based Risk Assessment Risk Communication Risk Communication RiskManagement Legally based
ANIMAL HEALTH LEGISLATION Currently Animal HealthLegislation Currently, Union rules on animal healthare laiddown in thefollowingactsoftheEuropeanParliament and oftheCouncil and in subsequentCommissionactsadoptedpursuant to them: • CouncilDirective64/432/EECon animal healthproblemsaffectingintra-Communitytrade in bovineanimals and swine ThisDirectiveapply to intra-Communitytrade in bovineanimalsand swine ANNEX A I. Officiallytuberculosis-free bovineherd ANNEX A II. Officiallybrucellosis-free bovineherds • CouncilDirective77/391/EECintroducingCommunitymeasuresfortheeradicationofbrucellosis, tuberculosis and leucosisin cattle
Currently Animal Health Legislation • COUNCIL DIRECTIVE 64/432/EEC • ANNEX AI.Officiallytuberculosis-free bovineherd • 1. A bovineherdisofficiallytuberculosis-free if: conditionsunderpoints: • (a) alltheanimals are free fromclinicalsignsoftuberculosis; • (b) allthebovineanimalsoversixweeksoldhavereactednegatively to at least twoofficialintradermaltuberculintestscarriedout in accordancewithAnnexB………. • (c) followingthecompletionofthefirst test referred to in (b), no bovine animal oversixweeksold has beenintroducedintotheherdunlessit has reactednegatively….. • 2. A bovineherdwillretainofficiallytuberculosis-free status if: • (a) theconditionsdetailed in 1(a) and (c) continue to apply; • (b) allanimalsenteringthe holding comefromherdsofofficiallytuberculosis-free status; • (c) allanimals on the holding, withtheexceptionofcalvesundersixweeksoldwhichwereborn in the holding, are subjected to routinetuberculintesting in accordancewithAnnex B atyearlyintervals………. • 3A. Theofficiallytuberculosis-free status of a herdis to besuspendedif: • (a) theconditionsdetailed in paragraph 2 are no longerfulfilledor • (b) oneor more animals are deemed to havegiven a positive reaction to a tuberculin test, or a case oftuberculosisissuspectedat post-mortemexamination.
Currently Animal Health Legislation • COUNCIL DIRECTIVE 64/432/EEC • ANNEX A II. Officiallybrucellosis-free bovineherds • 1. A bovineherdisofficiallybrucellosis-free if: • (a) itcontains no bovineanimalswhichhavebeenvaccinatedagainstbrucellosis, exceptfemaleswhichhavebeenvaccinatedat least threeyearspreviously; • (b) allthebovineanimalshavebeen free fromclinicalsignsofbrucellosisforat least sixmonths; • (c) allthebovineanimalsover 12 monthsoldhavebeensubjected to oneofthefollowing test regimeswith negative results in accordancewithAnnex C: • (i) twoserologicaltestsspecified in paragraph 10 atan interval of more thanthreemonths and lessthan 12 months; • (ii) threetests on milksamplesatthree-monthlyintervalsfollowedat least sixweekslater by a serological test specified in paragraph 10; (d) anybovine animal enteringtheherdcomesfrom a herdofofficiallybrucellosis-free status and, in the case ofbovineanimalsover 12 monthsold, has shown a brucella titre oflessthan 30 IU ofagglutination
Currently Animal Health Legislation COUNCIL DIRECTIVE 64/432/EEC • ANNEX D CHAPTER IOFFICIALLY ENZOOTIC-BOVINE-LEUKOSIS-FREE HERDS, MEMBER STATES AND REGIONS • A.Officiallyenzootic-bovine-leukosis-free herdmeans a herd in which: • (i) thereisno evidence, eitherclinicalor as a resultof a laboratory test, ofany case ofenzooticbovineleukosisin theherd and no such case has beenconfirmed in theprevioustwoyears; and • B.A herdshallretainofficiallyenzootic-bovine-leukosis-free status provided: • (i) thecondition in A(i) continues to befulfilled; • (ii) anyanimalsintroducedintotheherdcomefromanofficiallyenzootic-bovine-leukosis-free herd…. • C. Theofficiallyleukosis-free status of a herdis to besuspendediftheconditionsdetailed in B are not fulfilled, orwhere as a resultoflaboratorytests…..
Currently Animal Health Legislation • CouncilDirective91/68/EECon animal healthconditionsgoverningintra-Communitytrade in ovine and caprineanimals • CouncilDirective92/119/EECof 17 December 1992 introducinggeneralCommunitymeasuresforthecontrolofcertain animal diseases and specificmeasuresrelating to swinevesiculardisease • CouncilDirective2000/75/EC layingdownspecificprovisionsforthecontrol and eradicationofbluetongue • CouncilDirective2003/99/EC on themonitoring ofzoonoses and zoonoticagents, amendingCouncilDecision 90/424/EEC and repealingCouncilDirective92/117/EEC- to ensurethatzoonoses, zoonoticagents and relatedantimicrobialresistance are properlymonitored, and that food-borneoutbreaksreceive proper epidemiologicalinvestigation.
Currently Animal Health Legislation • REGULATION (EC) No 999/2001 layingdownrulesfortheprevention, control and eradicationofcertain transmissiblespongiformmencephalopathies(TSE) • laysdownrulesforthepreventioon, control and erradicationof TSE • ANNEX II Determinationof BSE status: • Chapter A - Criteria, • Chapter B – Risk analysis, • Chapter C - Definitionofcategories: • negligiblerisk, • controlledrisk • undetermined risk • Chapter D – minimalsurveillancerequirements
Currently Animal Health Legislation • ANNEX III Monitoring systém • Chapter A – 1 Monitorng in biovineanimals, 2 Monit in ovine and Cprineanimals • Chapter B – Recording and reporting requirements EachMemberState has to carryoutanannual monitoring programmeforTSEsbased on activesurveillance(testingwithoutprevioussuspicion) and passivesurveillance(testingofclinicalsuspectsidentified by veterinarians/farmers) whichapplies to bothbovineanimals and ovine and caprineanimals. • ANNEX V Specified risk materiál (SRM) • 1. Definitionof SRM, 2. Derogationfor MS, 3. Marking nad disposal • 4. Removalof SRM
Currently Animal Health Legislation • REGULATION (EC) No 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No. 1774/2002 (Animal by-products Regulation). • Section 4 Categorisation • Article 7 Categorisation of animal by-products and derived products 1. Animal by-products shall be categorised into specific categories which reflect the level of risk to public and animal health arising from those animal by-products, in accordance with the lists laid down in: • Articles 8 - Category 1 material • Article 9 - Category 2 material • Article 10 - Category 3 material
Currently Animal Health Legislation • Council Directive 92/66/EEC - Community measures for the control of Newcastle disease • Council Directive 2005/94/EC on Community measures for the control of avian influenza and repealing Directive 92/40/EEC • Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever • Council Directive 2002/60/EC laying down specific provisions for the control of African swine fever and amending Directive 92/119/EEC as regards Teschen disease and African swine fever • Council Directive 2003/85/EC on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC
Currently Animal Health Legislation EU & OIE FMD Legislation • EU- CouncilDirective 2003/85/EC on Communitymeasuresforthecontroloffoot-and-mouthdisease • OIE-OIE Terrestrial Code, chapter 8.5 - OIE Terrestrial Manual, chapter 2.1.5 • The OIE has set international standards • Standards for FMD surveillance • Standards for FMD diagnostics and vaccines • Standards for dealing with FMD in relation with international trade of animals and animal products • Standards and procedures for the recognition of the FMD status of a country or zone
Currently Animal Health Legislation OIE FMD Legislation Recognitionof FMD OIE status • FMD - most important trade-distorting disease, countries/zones considering themselves free from FMD, want that status to be officially recognized. An official recognition provides the country/zone with increased opportunities for international trade. • The OIE recognizes 5 different categories: • A country free from FMD without vaccination • A zone free from FMD without vaccination • A country free from FMD with vaccination • A zone free from FMD withvaccination • A country or zone infected with FMD
Currently EU Animal Health Legislation EU FMD Legislation CouncilDirective 2003/85/EC on Communitymeasuresforthecontroloffoot-and-mouthdisease(http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02003L0085-20130701&qid=1423911432593) • Article1 -ThisDirectivesetsout: • (a) theminimum controlmeasuresto beapplied in theeventofanoutbreakoffoot-and-mouthdiseaseofwhatever type of virus; • (b) certainpreventativemeasuresaimedatincreasingawareness and preparednessofthecompetentauthorities and thefarmingcommunityforfoot-and-mouthdisease.
EU FMD Legislation • Article3 - Foot-and-mouthdiseasenotification • Article4 Measuresin case ofsuspicionofanoutbreakoffoot-and-mouthdisease to betaken • place thesuspect holding underofficial surveillance as soon as thesuspectedinfectionisnotified, • activateofficialinvestigatíonincludingsampling to confirmor rule outthe presence ofthefoot-and-mouthdisease • Article 5 Movementsonto and off a holding in case ofsuspicionofanoutbreakoffoot-and-mouthdisease are banned • Article6 Extensionofmeasures to otherholdings • Article7 Temporarycontrolzones, (protection and surveillance zones) • officialinvestigations, • temporaryban on movements
EU FMD Legislation • MEASURES IN CASE OF SUSPICION OF AN OUTBREAK OF FOOT-AND-MOUTH DISEASE • Article 10 - Measures in case of confirmation of an outbreak of foot-and-mouth disease • All animals of susceptible species shall be killed on-the-spot under official supervision, in such a way to avoid risk of spreadsing • Appropriates samples need to be taken • Carcasses of animals of susceptible species, died and/orkilled shall be processed without undue delay under official, buried or burned, on site or off site, • Article 11 Cleansing and disinfection • Article 12 Tracing and treatment of products and substances derived from or having been in contact with animals of an outbreak of foot-and-mouth disease • Article 13 Epidemiological inquiry – tracing back, tracing forward • Article 21 Establishment of protection and surveillance zones
EU FMD Legislation • Vaccination • preventive vaccination – EU MS aply nonvacination policy as OIE FMD free countries without vaccination • emergency vaccination – outbreaks confirmed, threat of spread • protective vaccination - means emergency to protect animals of susceptible species within designated area against airborne spread or spread through fomites of foot-and-mouth disease, animals intended to be kept alive following vaccination; • suppressive vaccination’ means emergency vaccination to reduce the amount of foot-and-mouth disease virus circulating and to reduce the risk of it spreading where the animals are intended to be destroyed following vaccination;
EU FMD Legislation PREVENTATIVE MEASURES • Article66 - Checksoflaboratories and establishmentshandlinglive FMDV - spot-checks to ascertainwhetherthesecuritysystemsappliedcomplywiththe bio-securitystandards set out in Annex XII. • Article 68 - NationalLaboratories • Article69 - CommunityReference Laboratory • OIE Worldrefferencelaboratory • Article71- Standardsand testsforthediagnosisoffoot-and-mouthdisease and forthedifferentialdiagnosisofothervesiculardiseases • set out in Annex XIII. • arrangementsforthepurchase, storage and supply to nationallaboratoriesofsufficientquantitiesofspecificreagentsordiagnostictests in accordancewithArticle 89(2).
EU FMD Legislation • PREVENTATIVE MEASURES • CONTINGENCY PLANS AND REAL TIME ALERT EXERCISES • Article72 - Contingencyplans - have to beapproved by the EC (Article 89(2)) • specifyingthenationalmeasuresrequired to maintain a highleveloffoot-and-mouthdiseaseawareness and preparedness • providefortheaccess to allfacilities, equipment, personnel and otherappropriatematerialsnecessaryfortherapid and efficienteradicationofanoutbreakoffoot-and-mouthdisease…………… • Article73 - Real-timealertexercises (Simulationexcercise) • MemberStatesshallensurethatreal-timealertexercises are carriedout in accordancewiththeirapprovedcontingencyplan and AnnexXVII. • carriedout in closecollaborationwiththecompetentauthoritiesofneighbouringMemberStatesorthirdcountries.
EU CSF Legislation http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0089-20080903&rid=1 • COUNCIL DIRECTIVE 2001/89/EC of23 October2001 on Communitymeasuresforthecontrolofclassicalswinefever • Article1 – Objectives- ThisDirectiveintroducestheminimum Communitymeasuresforthecontrolofclassicalswinefever. • Article3- Classicalswinefevernotification- thepresence and suspected presence ofclassicalswinefever are compulsorily and immediatelynotifiable to thecompetentauthority. • Article4 - Measuresin case ofsuspicionofthe presence ofclassicalswinefever in pigs on a holding • Article 5 Measuresin case ofconfirmationofthe presence ofclassicalswinefever in pigs on a holding …………………….
EU ASF Legislation • CouncilDirective2002/60/EC - minimum measures to beappliedwithinthe Union forthecontrolofAfricanswinefever • includingthemeasures to betaken in theeventofanoutbreakofAfricanswinefever on a pig holding and in caseswhereAfricanswinefeverissuspectedorconfirmed in feralpigs. • COMMISSION IMPLEMENTING DECISION 2014/709/EUof9 October 2014 • concerning animal healthcontrolmeasuresrelating to Africanswinefever in certainMemberStates and repealingImplementingDecision2014/178/EU • Prohibition on thedispatchof live pigs, porcine semen, ova and embryo, pigmeat, pigmeatpreparations, pigmeatproducts and anyotherproductscontainingpigmeat as well as consignmentsof animal by-productsfromporcineanimalsfromcertainareaslisted in theAnnex. Derogationundercertaincircumstances
EU Salmonella legislation • Regulation (EC) No 2160/2003 of the European Parliament and of the Council on the control of salmonella and other specified food-borne zoonotic agents • The main animal species likely to transmit an infectionor infestation are poultry and pigs for which Members shall establish control programmesdeveloped in accordance with the provisions laid down in this Directive.
EU Salmonella legislation • The purpose of this Regulation is to ensure that • proper and effective measures are taken todetect and control Salmonella and other zoonotic agents • at all relevant stages of production, processing and distribution, • particularly at the level of primary production, in order • to reduce their prevalence and the risk they pose to public health.
EU Salmonella legislation • COMMISSION REGULATION (EU)No 200/2010 implementingRegulation (EC) No 2160/2003 as regards a Union targetforthereductionofthe prevalence ofSalmonellaserotypes in adultbreedingflocksofGallusgallus. • National program ofthe CR- coversthewhole country – allregisteredadultbreedingflocksofGallusgallus-thetargetis to reducepourcentageofpositive flocksunder 1%.
EU Salmonella legislation COMMISSION REGULATION (EU) No 517/2011 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards a Union target for the reduction of the prevalence of certain Salmonella serotypes in laying hens of Gallus gallus producing eggs for human consuption. National program of the CR- the target is to reduce the Salmonella Enteritidis and/or pourcentage Typhi murium flock positivity at 2% or less This programme does not concerne the flocks produsing the eggs for the hosehold use and/or selling to the local market which sell to final consumer only
EU Salmonella legislation • COMMISSION REGULATION (EU) No 200/2012 concerning a Union targetforthereductionofSalmonellaEnteritidis and SalmonellaTyphimurium in flocksofbroilers. Thetargetisthereductionofmaximalannualpercentageofflocks and adultturkeyflocksremaining positive forSalmonellaEnteritidis and SalmonellaTyphimuriumequalto 1% orless
EU Salmonella legislation COMMISSION REGULATION (EU) No 1190/2012 concerning a Union target for the reduction of Salmonella Enteritidis and Salmonella Typhi murium in flocks of turkeys. The target is the reduction of maximal annual percentage of fattening turkey flocks remaining positive for Salmonella Enteritidis and Salmonella Typhi murium equal to 1% or less
The New EU Animal Health Legislation • WHY A NEW LAW ? COMMUNICATION OF THE EC TO THE EP AND EUC (http://eurlex.europa.eu/legalcontent/EN/TXT/?uri=CELEX:52007DC0539) • Themainelementsoftheexistingpolicyweredrawn up largelybetween 1988 and 1995 • Tradingconditionshavechangedradicallywiththevolumeoftrade in animal products, bothwithinthe EU and withthirdcountries; • Science, technology and institutionalframeworkhaveevolved • In December 2004, theCommissionlaunchedanexternalevaluation to thoroughlyreviewtheoutcomesof EU action on animal health • Based on theevaluationresults and thestakeholderconsultation, theCommissionpresenteditsproposalfor a new EU Animal HealthStrategy (2007-2013).
The New EU Animal Health Legislation • The new EU Animal Health Strategy (2007-2013) encompasses a challenging 6 year programme of work aimed towards clear outcomes: • Prioritisation of EU intervention • A modern and appropriate animal health framework • Better prevention, surveillance and crisis preparedness • Science, Innovation and Research • Vision -“Prevention is better than cure” • Purpose - direction for the development of animal health policy, to high standards of animal health • Scope of the Strategy - the concept of animal health covers not only the absence of disease in animals, but also the critical relationship between the health of animals and their welfare. It is also a pillar for the Commission's policy on public health and food safety.
The New EU Animal Health Legislation Thestrategy’sgoals are: • Goal1: to ensure a highlevelof public health and food safetyby minimisingthe incidence ofbiologicaland chemicalrisks to humans; • Goal2: to promote animal healthby preventing/reducingthe incidence of animal diseases, and in thisway to support farming and theruraleconomy • Goal3: to improveeconomicgrowth/cohesion/competitivenessassuringfree circulationofgoods and proportionateanimal • Goal4: to promotefarmingpracticesand animal welfarewhichprevent animal healthrelatedthreatsand minimiseenvironmentalimpacts in support ofthe EU SustainableDevelopmentStrategy
The New EU Animal Health Legislation • Thenew Animal Healthstrategy- anintegrated risk assessment and management strategyfocusing on biological and chemicalrisksof EU relevance • Categorisationof animal-relatedthreats: • Profiling and categorisationofbiological and chemicalriskswillprovidethebasisfordecisions on wheretheresponsibilityforactionlies. • Identifiedthreats to animal healthmustbeassessed to determine: • theirrelevance to thefourhighlevelgoalsofthe EU strategy; • the“ acceptablelevelof risk ”(AppropriateLevelofProtection (ALOP)isthelevelofprotectiondeemedappropriate by the country establishing a sanitarymeasure to protecthumanlifeorhealthwithinitsterritory. (Thisconceptmayotherwisebereferred to as the “acceptablelevelof risk”.)fortheCommunity; • therelative priority foraction to reducethe risk.
The New EU Animal Health Legislation Expectedoutcomes • An EU Animal Health General Law: • A single horizontallegalframeworkwilldefine and integratecommonprinciples and requirementsofexistinglegislation • Existinglegislationwillbesimplifiedand replaced by thisnewframework as appropriate, seekingconvergence to internationalstandards (OIE/Codexstandards) whileensuring a firmcommitment to highstandardsof animal health.
The New EU Animal Health Legislation • More risk based, proactive, preventive • Horizontalprinciplesand rulesfortransmissiblediseases • Simplifyexistingrules - Numerically - In substance • AlignwithLisbonTreaty
The New EU Animal Health Legislation • Fromfragmentedof cca 40 Directives and Regulations • Toa single and robulstlegal Framework for AH • Lyingdown and overarchingprinciplesfor: • Diseaseprevention(diseaseawareness, registration, tracaebility, biosecurity) • Diseasecontroland eradication • Intra-EU movementsand entryintothe EU ofanimals and animal products • Emergencymeasures • Suplementingrulesneeded to ensurecompleteimplementation • DeatailedprovisionsofthecurrentDirectives and Regulationincluded in delegated and implementingacts
The New EU Animal Health Legislation • WhatisoutofAnimalmHealthLaw ? • Not in scope: • Animal Welfare • Veterinarychecks, controls • EU veterinaryexpenditure • Feed, medicatedfeed • Veterinarymedicines • Veterinaryeducation • In scope but specificrulesremain in place: • ABP´s • TSE rules • Certainzoonosis (e.g. Salonella )
The New EU Animal Health Legislation AHL – New elements • More prevention: • Biosecurityatfarms, in transport, assembly, atborders • Enhanced surveillance, diseasenotification and reporting • Clearerpolicyforthe use ofvaccines and in relation to thediseasediagnosis and control • Easier and safytrade: • Enhancedconvergencewithinternationalstandards on animal health (OIE) • Compartmentalisation • Requiremntsfor export
Capacity building of the competent authorities for food safety, veterinary and phytosanitary policy EuropeAid/132281/D/SER/MK Thank you for your attention!!!
Capacity building of the competent authorities for food safety, veterinary and phytosanitary policy EuropeAid/132281/D/SER/MK CONTACTS: Name of the Expert: HOLEJŠOVSKY Josef, DVM, PhD E- mail: jholejsovsky@seznam.cz