Training courseTraining course

Lecturer:Lecturer:MVDr. Josef Holejšovský PhDMVDr. Josef Holejšovský PhD

Place: Place: Skopie, FYROMSkopie, FYROM Date:Date: 1818--2222 M Mayay 201 20155

Capacity building of the competent authorities for food safety, veterinary and phytosanitary policy

EuropeAid/132281/D/SER/MK

Title A: Overview of EU legislation on Animal Health

Content:Content:

Capacity building of the competent authorities for food safety, veterinary and phytosanitary policy

EuropeAid/132281/D/SER/MK

History and History and Development of EU Veterinary LegislationEU Veterinary Legislation

• 1. 1. In 1957 the In 1957 the Rome Treaty Rome Treaty signed and the EEC signed and the EEC createdcreated

• 2.Common Agr2.Common Agriculturalicultural Policy Policy ( (CAPCAP)) became the became the most important issue regarding the food supplymost important issue regarding the food supply independenceindependence

• 3.3.Differences in veterinary policy caused Differences in veterinary policy caused • by by different animal health statusdifferent animal health status• 4.4.Different veterinary policy Different veterinary policy – – obstacles obstacles • for free movement for free movement i.e. for single marketi.e. for single market • of animals and animal's origin product.of animals and animal's origin product.

History and History and Development of EU Veterinary LegislationEU Veterinary Legislation

5. 5. In 1964 first veterinary directives In 1964 first veterinary directives adopted- adopted- Council Directives Council Directives 64/432 and 64/433/EEC 64/432 and 64/433/EEC laing down requirements concerning animal healths laing down requirements concerning animal healths and and food safety for and and food safety for intintrracommunity trade acommunity trade (placing (placing on the community market).on the community market). 6. In 1972 1972 further directive adopted i.e. further directive adopted i.e. CD 72/462/EEC covering the same areas CD 72/462/EEC covering the same areas while while trading with third countriestrading with third countries

History and History and Development of EU Veterinary LegislationEU Veterinary Legislation

77. In 1987 – European Single Market Act. In 1987 – European Single Market Act- the - the most productive period as for the Veterinary most productive period as for the Veterinary legislation began.legislation began.

8. 8. In 1988 Strategic Document In 1988 Strategic Document – basis for – basis for preparation of veterinary legislation leading preparation of veterinary legislation leading towards full harmonisation till the end of towards full harmonisation till the end of 1992 (Mastricht Treaty on EU) .1992 (Mastricht Treaty on EU) .

History and History and Development of EU Veterinary LegislationEU Veterinary Legislation

Main Points of Strategic Document:Main Points of Strategic Document:

•full full harmonization harmonization of veterinary legislaton over the whole of veterinary legislaton over the whole territory of EU Member Statesterritory of EU Member States•the same status the same status as for the animal and public health in all as for the animal and public health in all MS at highest level possibleMS at highest level possible•clasification of diseases clasification of diseases in compliance with their in compliance with their importance for animal and human healthimportance for animal and human health•new systeme new systeme of control and supervisionof control and supervision• new health safety definition- new health safety definition- principle of regionalizationprinciple of regionalization

Institutions of the European UnionInvolved in Legal Process

The Council of the European Unionrepresents the EU member states

The European Parliamentrepresents the EU citizens

The European Commissionrepresents the EU as a whole

The EU Legislative Process

.

Initiative Consultati

on Decision

making

European Commission

Europea

n

Parliam

ent

Council of

Ministers

Legal Acts

Regulation - directly applicable and binding on all Member States (MS)

Directive - transposed in to the national legislation. MS must adopt national measures to meet its objectives (to achieve the same effect)

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

• Offical Feed and Food Controls and Auditss 854/2004/EC, 882/2004/EC

Risk analysis as main principleThe Components

of Risk Analysis

Risk Assessment

Risk AssessmentScientifically Based

RiskManagementLegally based

Risk Communication Risk Communication

ANIMAL HEALTH LEGISLATION

Currently Animal Health Legislation

Currently, Union rules on animal health are laid down in the following acts of the European Parliament and of the Council and in subsequent Commission acts adopted pursuant to them:

•Council Directive 64/432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine This Directive apply to intra-Community trade in bovine animals and swine

ANNEX A I. Officially tuberculosis-free bovine herd ANNEX A II. Officially brucellosis-free bovine herds

•Council Directive 77/391/EEC introducing Community measures for the eradication of brucellosis, tuberculosis and leucosis in cattle

Currently Animal Health Legislation• COUNCIL DIRECTIVE 64/432/EEC

– ANNEX A I. Officially tuberculosis-free bovine herd– 1. A bovine herd is officially tuberculosis-free if: conditions under points:– (a) all the animals are free from clinical signs of tuberculosis;– (b) all the bovine animals over six weeks old have reacted negatively to at least two official intradermal

tuberculin tests carried out in accordance with Annex B………. – (c) following the completion of the first test referred to in (b), no bovine animal over six weeks old has

been introduced into the herd unless it has reacted negatively…..

– 2. A bovine herd will retain officially tuberculosis-free status if:– (a) the conditions detailed in 1(a) and (c) continue to apply;– (b) all animals entering the holding come from herds of officially tuberculosis-free status;– (c) all animals on the holding, with the exception of calves under six weeks old which were born in the

holding, are subjected to routine tuberculin testing in accordance with Annex B at yearly intervals……….

• 3A. The officially tuberculosis-free status of a herd is to be suspended if:• (a) the conditions detailed in paragraph 2 are no longer fulfilled or• (b) one or more animals are deemed to have given a positive reaction to a tuberculin test, or a case of

tuberculosis is suspected at post-mortem examination.

Currently Animal Health Legislation

• COUNCIL DIRECTIVE 64/432/EEC– ANNEX A II. Officially brucellosis-free bovine herds

• 1. A bovine herd is officially brucellosis-free if:• (a) it contains no bovine animals which have been vaccinated against brucellosis, except

females which have been vaccinated at least three years previously;• (b) all the bovine animals have been free from clinical signs of brucellosis for at least six

months;• (c) all the bovine animals over 12 months old have been subjected to one of the following

test regimes with negative results in accordance with Annex C:– (i) two serological tests specified in paragraph 10 at an interval of more than three

months and less than 12 months;– (ii) three tests on milk samples at three-monthly intervals followed at least six weeks

later by a serological test specified in paragraph 10;(d) any bovine animal entering the herd comes from a herd of officially brucellosis-free

status and, in the case of bovine animals over 12 months old, has shown a brucella titre of less than 30 IU of agglutination

Currently Animal Health LegislationCOUNCIL DIRECTIVE 64/432/EEC•ANNEX D CHAPTER I OFFICIALLY ENZOOTIC-BOVINE-LEUKOSIS-FREE HERDS, MEMBER STATES AND REGIONS•A. Officially enzootic-bovine-leukosis-free herd means a herd in which:•(i) there is no evidence, either clinical or as a result of a laboratory test, of any case of enzootic bovine leukosis in the herd and no such case has been confirmed in the previous two years; and•B. A herd shall retain officially enzootic-bovine-leukosis-free status provided:•(i) the condition in A(i) continues to be fulfilled;•(ii) any animals introduced into the herd come from an officially enzootic-bovine-leukosis-free herd….•C. The officially leukosis-free status of a herd is to be suspended if the conditions detailed in B are not fulfilled, or where as a result of laboratory tests…..

Currently Animal Health Legislation• Council Directive 91/68/EEC on animal health conditions governing

intra-Community trade in ovine and caprine animals

• Council Directive 92/119/EEC of 17 December 1992 introducing general Community measures for the control of certain animal diseases and specific measures relating to swine vesicular disease

• Council Directive 2000/75/EC laying down specific provisions for the control and eradication of bluetongue

• Council Directive 2003/99/EC on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC- to ensure that zoonoses, zoonotic agents and related antimicrobial resistance are properly monitored, and that food-borne outbreaks receive proper epidemiological investigation.

Currently Animal Health Legislation• REGULATION (EC) No 999/2001 laying down rules for the

prevention, control and eradication of certain transmissible spongiformm encephalopathies (TSE)• lays down rules for the preventioon, control and erradication of TSE

• ANNEX II Determination of BSE status:• Chapter A - Criteria, • Chapter B – Risk analysis, • Chapter C - Definition of categories:

• negligible risk, • controlled risk • undetermined risk• Chapter D – minimal surveillance requirements

Currently Animal Health Legislation• ANNEX III Monitoring systém• Chapter A – 1 Monitorng in biovine animals, 2 Monit in ovine and

Cprine animals• Chapter B – Recording and reporting requirements

Each Member State has to carry out an annual monitoring programme for TSEs based on active surveillance (testing without previous suspicion) and passive surveillance (testing of clinical suspects identified by veterinarians/farmers) which applies to both bovine animals and ovine and caprine animals.

• ANNEX V Specified risk materiál (SRM)• 1. Definition of SRM, 2. Derogation for MS, 3. Marking nad disposal• 4. Removal of 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 - Council Directive 2003/85/EC on Community measures for the control of foot-and-mouth disease

•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 Recognition of 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 with vaccination

•A country or zone infected with FMD 

Currently EU Animal Health Legislation

EU FMD LegislationCouncil Directive 2003/85/EC on Community measures for the control of foot-and-mouth disease (http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02003L0085-20130701&qid=1423911432593)

•Article 1 -  This Directive sets out:

• (a) the minimum control measures to be applied in the event of an outbreak of foot-and-mouth disease of whatever type of virus;

• (b) certain preventative measures aimed at increasing awareness and preparedness of the competent authorities and the farming community for foot-and-mouth disease.

EU FMD Legislation• Article 3 - Foot-and-mouth disease notification

• Article 4 Measures in case of suspicion of an outbreak of foot-and-mouth disease to be taken – place the suspect holding under official surveillance as soon as the

suspected infection is notified, – activate official investigatíon including sampling to confirm or rule out the

presence of the foot-and-mouth disease

• Article 5 Movements onto and off a holding in case of suspicion of an outbreak of foot-and-mouth disease are banned

• Article 6 Extension of measures to other holdings

• Article 7 Temporary control zones, (protection and surveillance zones)– official investigations, – temporary ban 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 LegislationPREVENTATIVE MEASURES

•Article 66 - Checks of laboratories and establishments handling live FMDV - spot-checks to ascertain whether the security systems applied comply with the bio-security standards set out in Annex XII.

– Article 68 - National Laboratories

– Article 69 - Community Reference Laboratory

– OIE World refference laboratory

•Article 71- Standards and tests for the diagnosis of foot-and-mouth disease and for the differential diagnosis of other vesicular diseases

– set out in Annex XIII.– arrangements for the purchase, storage and supply to national laboratories of

sufficient quantities of specific reagents or diagnostic tests in accordance with Article 89(2).

EU FMD Legislation• PREVENTATIVE MEASURES• CONTINGENCY PLANS AND REAL TIME ALERT EXERCISES• Article 72 - Contingency plans - have to be approved by the EC (Article 89(2))

– specifying the national measures required to maintain a high level of foot-and-mouth disease awareness and preparedness

– provide for the access to all facilities, equipment, personnel and other appropriate materials necessary for the rapid and efficient eradication of an outbreak of foot-and-mouth disease……………

• Article 73 - Real-time alert exercises (Simulation excercise)

– Member States shall ensure that real-time alert exercises are carried out in accordance with their approved contingency plan and Annex XVII.

– carried out in close collaboration with the competent authorities of neighbouring Member States or third countries.

EU CSF Legislationhttp://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02001L0089-20080903&rid=1

•COUNCIL DIRECTIVE 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever

– Article 1 – Objectives - This Directive introduces the minimum Community measures for the control of classical swine fever.

– Article 3 - Classical swine fever notification - the presence and suspected presence of classical swine fever are compulsorily and immediately notifiable to the competent authority.

– Article 4 - Measures in case of suspicion of the presence of classical swine fever in pigs on a holding

– Article 5 Measures in case of confirmation of the presence of classical swine fever in pigs on a holding …………………….

EU ASF Legislation

• Council Directive 2002/60/EC - minimum measures to be applied within the Union for the control of African swine fever

– including the measures to be taken in the event of an outbreak of African swine fever on a pig holding and in cases where African swine fever is suspected or confirmed in feral pigs.

• COMMISSION IMPLEMENTING DECISION 2014/709/EUof 9 October 2014– concerning animal health control measures relating to African swine

fever in certain Member States and repealing Implementing Decision 2014/178/EU

– Prohibition on the dispatch of live pigs, porcine semen, ova and embryo, pig meat, pig meat preparations, pig meat products and any other products containing pig meat as well as consignments of animal by-products from porcine animals from certain areas listed in the Annex. Derogation under certain circumstances

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 infection or infestation are poultry and pigs for which Members shall establish control programmes developed 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 to detect

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 implementing Regulation (EC) No 2160/2003 as regards a Union target for the reduction of the prevalence of Salmonella serotypes in adult breeding flocks of Gallus gallus.

• National program of the CR- covers the whole country – all registered adult breeding flocks of Gallus gallus-the target is to reduce pourcentage of positive flocks under 1%.

EU Salmonella legislationCOMMISSION REGULATION (EU) No 517/2011implementing 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 200/2012concerning a Union target for the reduction of Salmonella

Enteritidis and Salmonella Typhi murium in flocks of broilers.

The target is the reduction of maximal annual percentage of flocks and adult turkey flocksremaining positive for Salmonella Enteritidis and Salmonella Typhi muriumequal to 1% or less

EU Salmonella legislation

COMMISSION REGULATION (EU) No 1190/2012concerning 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)

• The main elements of the existing policy were drawn up largely between 1988 and 1995

• Trading conditions have changed radically with the volume of trade in animal products, both within the EU and with third countries;

• Science, technology and institutional framework have evolved • In December 2004, the Commission launched an external evaluation to

thoroughly review the outcomes of EU action on animal health• Based on the evaluation results and the stakeholder consultation, the

Commission presented its proposal for a new EU Animal Health Strategy (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

The strategy’s goals are:•Goal 1: to ensure a high level of public health and food safety by minimising the incidence of biological and chemical risks to humans;•Goal 2: to promote animal health by preventing/reducing the incidence of animal diseases, and in this way to support farming and the rural economy •Goal 3: to improve economic growth/cohesion/competitiveness assuring free circulation of goods and proportionate animal•Goal 4: to promote farming practices and animal welfare which prevent animal health related threats and minimise environmental impacts in support of the EU Sustainable Development Strategy

The New EU Animal Health Legislation• The new Animal Health strategy - an integrated risk assessment and

management strategy focusing on biological and chemical risks of EU relevance

• Categorisation of animal-related threats:– Profiling and categorisation of biological and chemical risks will provide

the basis for decisions on where the responsibility for action lies.

• Identified threats to animal health must be assessed to determine:– their relevance to the four high level goals of the EU strategy;– the “ acceptable level of risk ”(Appropriate Level of Protection (ALOP) is the

level of protection deemed appropriate by the country establishing a sanitary measure to protect human life or health within its territory. (This concept may otherwise be referred to as the “acceptable level of risk”.) for the Community;

– the relative priority for action to reduce the risk.

The New EU Animal Health Legislation

Expected outcomes

•An EU Animal Health General Law :

– A single horizontal legal framework will define and integrate common principles and requirements of existing legislation

– Existing legislation will be simplified and replaced by this new framework as appropriate, seeking convergence to international standards (OIE/Codex standards) while ensuring a firm commitment to high standards of animal health.

The New EU Animal Health Legislation

• More risk based, proactive, preventive

• Horizontal principles and rules for transmissible diseases

• Simplify existing rules - Numerically - In substance

• Align with Lisbon Treaty

The New EU Animal Health Legislation

• From fragmented of cca 40 Directives and Regulations• To a single and robulst legal Framework for AH• Lying down and overarching principles for:

– Disease prevention (disease awareness, registration, tracaebility, biosecurity)

– Disease control and eradication– Intra-EU movements and entry into the EU of animals and

animal products– Emergency measures

• Suplementing rules needed to ensure complete implementation– Deatailed provisions of the current Directives and Regulation

included in delegated and implementing acts

The New EU Animal Health Legislation• What is out of Animalm Health Law ?• Not in scope:

– Animal Welfare– Veterinary checks, controls– EU veterinary expenditure– Feed, medicated feed– Veterinary medicines– Veterinary education

• In scope but specific rules remain in place:– ABP´s– TSE rules– Certain zoonosis (e.g. Salonella )

The New EU Animal Health Legislation

AHL – New elements•More prevention:

– Biosecurity at farms, in transport, assembly, at borders– Enhanced surveillance, disease notification and reporting– Clearer policy for the use of vaccines and in relation to the

disease diagnosis and control•Easier and safy trade:

– Enhanced convergence with international standards on animal health (OIE)

– Compartmentalisation– Requiremnts for export

Capacity building of the competent authorities for food safety, veterinary and

phytosanitary policy

EuropeAid/132281/D/SER/MK

CONTACTS:CONTACTS:

E- mail: jholejsovsky@seznam.cz

Name of the Expert: HOLEJŠOVSKY Josef, DVM, PhD

Capacity building of the competent authorities for food safety, veterinary and phytosanitary policy

EuropeAid/132281/D/SER/MK