mvdr. josef holejšovský, ph.d. institut of tropics and subtropics

European Union Veterinary legislation

Animal Health andFood Safety Control

MVDr. Josef Holejšovský, Ph.D.MVDr. Josef Holejšovský, Ph.D.

Institut of Tropics and SubtropicsInstitut of Tropics and SubtropicsCzech University of Life SciencesCzech University of Life Sciences

PraguePrague

European Union and

Veterinary Legislation

Developpment of Cmmunity

Veterinary Legislatin

Developpment ofEUEU Veterinary LegislationVeterinary Legislation

1. 1. In 1957In 1957 the the Rome TreatyRome Treaty signed and signed and the EEC created the EEC created

2.2.CCommon ommon AAgar gar PPolicyolicy became the most became the most important issue regarding the important issue regarding the food food supplysupply independenceindependence

3.3.Differences in veterinary policyDifferences in veterinary policy caused caused

by by different animal health statusdifferent animal health status

4.4.Different veterinary policy – Different veterinary policy – obstaclesobstacles for free movementfor free movement i.e. for single i.e. for single

marketmarket of animals and animal's origin of animals and animal's origin

product.product.

Developpment ofEUEU Veterinary Veterinary

LegislationLegislation5.5. In 1964In 1964 first veterinary directives first veterinary directives

adopted- adopted- Council DirectivesCouncil Directives 64/43264/432 and and 64/433/EEC64/433/EEC laing down laing down requirements requirements concerning animal concerning animal healths and and food safetyhealths and and food safety for for intacommunity trade (placing on the intacommunity trade (placing on the community market).community market).

6. In 19721972 further directive adopted i.e. further directive adopted i.e. CD 72/462/EECCD 72/462/EEC covering covering the same the same

areasareas while trading while trading with third countrieswith third countries

Developpment ofEU Veterinary LegislationEU Veterinary Legislation

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

8. 8. In 1988In 1988 Strategic DocumentStrategic Document – – basis for preparationbasis for preparation of of

veterinary legislation leading veterinary legislation leading towards towards full harmonisation till full harmonisation till the the end of end of 1992 1992 ((Mastricht Mastricht TreatyTreaty on EU) on EU) . .

Main Points of Strategic Main Points of Strategic DocumentDocument::

• full harmonizationfull harmonization of veterinary of veterinary legislatonlegislaton over the whole territory of over the whole territory of EU Member StatesEU Member States• the same statusthe same status as for as for the animal and the animal and public healthpublic health in all MS at highest in all MS at highest levellevel possiblepossible• clasification of diseasesclasification of diseases in compliance in compliance with their importance for animal and with their importance for animal and human healthhuman health• new systemenew systeme of control and of control and supervisionsupervision• new health safety definition- principle new health safety definition- principle of of regionalizationregionalization

GoalGoal GoalGoal

The European

Parliament

The Council of the European

Union

The European

Commission

The European Court of Justice

European Court of auditors

European Investment

Bank

Economic and Social

Committee

Committee of the Regions

European Ombudsman

Institutions of the European

Union involved in Legal Process

Institutions of the European Union

Involved in Legal ProcessThe Council of the European Union

represents the EU member states

The European Parliamentrepresents the EU citizens

The European Commissionrepresents the EU as a whole

The EU Legislative Process

.

Initiative Consultatio

n Decision

making

European Commission

Euro

pean

Parli

amen

t

Council of

Ministers

Legal Instruments 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

European Union Food Legislation

Food Hygiene17 Directives64/43371/11872/46177/9677/9980/21589/36289/437

91/49291/49391/49491/49592/4592/4692/4894/6593/43

Which are covering

Hygiene of foodstuffs

Fresh meat Fresh Poultry meat Fresh meat Pigmeat 3r

Countries Meat Products Animal

Health/meat Minced Meat

Egg Products Bivalve molluscs Fishery products

Fishing vessels Poultymeat - 3rd Milk &

MilkProduction Rabbit and game Wild game

Developpement of the New EU Food Legislation

From Green Paper towards the Food LawGreen 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 ba Green PaperGeneral 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

Green Paper of the EUFoccused :

On Food Legislation On its Comprehancivness On Lacks and Shortcommings in Food Legislation, Transparency and

Consistency Identifies Nonharmonized Legislation

Areas leading to Trade BarriersIdentifies implementation and

interpretation differencies on national level

THE WHITE PAPER ON FOOD SAFETY

Global comprehensive approach whole feed and food chain all feed and food

Clear division of responsibilities traceability/withdrawal of food risk analysis precautionary principle

New legal framework

General Food Law 178/2002/EC Hygiene Package 852 and 853,

/2004/EC Offical Feed and Food Controls and

Auditss 854/2004/EC, 882/2004/EC

All involved for import into the EU

European Union and


New EU Food Legislation

Regulation (EC) 178/2002 EU GENERAL FOOD LAW

Article 1 Aim and Scope This Regulation lays down the general

principles governing food and feed in general, and food and feed safety in particular, at Community and national level.

It establishes the European Food Safety Authority.

It lays down procedures for matters with a direct or indirect impact on food and feed

safety.

Regulation (EC) 178/2002 Article 1 Aim and Scope (2) This Regulation shall apply to all stages of production, processing and distribution of food and feed. It shall not apply to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption.

Regulation (EC) 178/2002 Article 3 Other definitions

1. ‘food law’ means the laws, regulations and administrative provisions governing food in general,

and food safety in particular, whether at Community or national level;

it covers any stage of production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals;

2. ‘food business’ means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food;

3. ‘food business operator’ means the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control;

Regulation (EC) 178/2002 Article 3 other definitions

7. ‘retail’ means the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets;

8. ‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves;

Regulation (EC) 178/2002 Article 3 other definitions

9. ‘risk’ means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard;

10. ‘risk analysis’ means a process consisting of three interconnected components: risk assessment, risk management and risk communication;

11. ‘risk assessment’ means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation;

12. ‘risk management’ means the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be,

selecting appropriate prevention and control options;

13. ‘risk communication’ means the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, feed and food businesses, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions;

Risk Probability of a hazard

(Likelihood of occurrence)

Severity of hazard (What type of effects if it does occur)

Risk perception

Risk Analysis

Risk Assessment: provides a scientific foundation for risk management and design food security plan

Risk Management: practical and effective food safety practices

Risk Communication: promotes communication, awareness, understanding and ownership of the Risk Assessment process and outcomes

Risk Assessment Outputs Risk Ranking of priority hazards

Significant hazards Severity

Risk Estimate Likelihood of occurrence

Justification of risk assignment Scientific basis

Control options Preventive measures

Basic Principles

Integrating risk management into food security planning, preparation and execution

Making risk decisions at the appropriate level

Accepting no unnecessary risk

Risk Communication

To employees

To media

To public

The Components of Risk Analysis

Risk Analysis

Risk Assessment

Risk AssessmentScientifically Based

Risk ManagementLegally based

Risk Communication Risk Communication

Regulation (EC) 178/2002 Article 3 other definitions 14. ‘hazard’ means a biological, chemical or physical

agent in, or condition of, food or feed with the potential to cause an adverse health effect;

15. ‘traceability’ means the ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution;

16. ‘stages of production, processing and distribution’

means any stage,including import, from and including the primary production of a food, up to and including its storage, transport, sale or supply to the final consumer and, where relevant, the importation, production, manufacture, storage, transport, distribution, sale and supply of feed;

Regulation (EC) 178/2002 Article 14 Food safety

requirements 1. Food shall not be placed on the

market if it is unsafe. 2. Food shall be deemed to be unsafe

if it is considered to be: (a) injurious to health;

(wholesomness) (b) unfit for human consumption.

Regulation (EC) 178/2002 Article 14 Food safety

requirements 3. In determining whether any food is

unsafe, regard shall be had: (a) to the normal conditions of use of the food by the

consumer and at each stage of production, processing and distribution, and

(b) to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods.

Regulation (EC) 178/2002

Reg. 178/2002 – EU GENERAL FOOD LAWlays down principles of EU Food Law Unsafe food must not be placed on market Applies to all food chain including farmers. Applies to agricultural inputs e.g. animal feed Feed traceability highlighted Food business operator primary responsibility

for safety of food produced Based on EU „Precautionary Principle“ x WTO

Regulation (EC) 178/2002 EU Food safety policy Goal

To ensure: a high level of protection of

human health and consumers' interest in relation to food,

taking into account diversity, including traditional products,

whilst ensuring the effective functioning of the

internal market.

Regulation (EC) 178/2002 Food Safety Basic principles

Scientific Risk Assessment separation from Risk Management European Food Safety Authority (EFSA) European Commission DG SANCO

Transparency and Public Participation Rapid Alert System Advisory Group on the Food Chain, Animal

and Plant Health

Regulation (EC) 178/2002 Food hygiene basic

principles Simplification

Create uniform procedures (e.g. HACCP, imports)

Create single framework for all food

Separation of responsibilities Prime responsibility with operators Competent authority verifies compliance

Food and Feed Producers obligations (1)

Safety Operators shall not place on the market

unsafe food or feed Responsibility Operators are responsible for the safety of

the food and feed which they produce, transport, store or sell

Traceability Operators shall be able to rapidly identify

any supplier or consignee


Transparency Operators shall immediately inform the

competent authorities if they have a reason to believe that their food or feed is not safe

Emergency

Operators shall immediately withdraw food or feed from the market if they have a reason to believe that it is not safe


Prevention Operators shall identify and regularly

review the critical points in their processes and ensure that controls are applied at these points

Co-operation Operators shall co-operate with the

competent authorities in actions taken to reduce risks

Regulation 852/2004/ECon Food Hygiene

Introduces General Hygienic

principles and requirements for all food

(of plant and animal origin)

Regulation 852/2004/ECLegal provisions

Article 1 Scope 1. This Regulation lays down general rules

for food business operators on the hygiene of foodstuffs, taking particular account of the following principles:

(a) primary responsibility for food safety rests with the food business operator;

(b) it is necessary to ensure food safety throughout the food chain, starting with primary production;

(c) it is important, for food that cannot be stored safely at ambient temperatures, particularly frozen food, to maintain the cold chain;


Article 1 Scope (1) (d) general implementation of procedures based on the HACCP principles, together with the application of Good Hygiene Practice, should reinforce food business operators' responsibility;

(e) guides to good practice are a valuable instrument to aid food business operators at all levels of the food chain with compliance with food hygiene rules and with the application of the HACCP principles;


Article 1 Scope (2) (f) it is necessary to establish microbiological criteria and temperature control requirements based on a scientific risk assessment; (g) it is necessary to ensure that imported foods are of at least the same hygiene standard as food produced in the Community, or are of an equivalent standard. This Regulation shall apply to all stages of

production, processing and distribution of food and to exports, and without prejudice to more specific requirements relating to food hygiene.


Article 1 Scope (3)

2. This Regulation shall not apply to:

(a) primary production for private domestic use;

(b) the domestic preparation, handling or storage of food for private domestic

consumption;


Article 1 Scope (4)

(c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments

directly supplying the final consumer;

(d) collection centres and tanneries which fall within the definition of food business only

because they handle raw material for the production of gelatine or collagen.


Article 1 Scope (5)

3. Member States shall establish, under national law, rules governing the activities referred to in paragraph

2(c). Such national rules shall ensure the

achievement of the objectives of this Regulation.


ANNEX I PRIMARY PRODUCTION PART A: GENERAL HYGIENE PROVISIONS FOR

PRIMARY PRODUCTION AND ASSOCIATED OPERATIONS

III. Record-keeping 7. Food business operators are to keep and retain records

relating to measures put in place to control hazards in an appropriate manner and for an appropriate period, commensurate with the nature and size of the food business.

Food business operators are to make relevant information contained in these records available to the competent

authority and receiving food business operators on request.

Regulation 852/2004/EC General principles

Farm-to-table Primary production HACCP based procedures Microbiological criteria Registration of food businesses Guides to good practice Flexibility (traditional production,

processing and distribution) Technical requirements

Regulation 852/2004/EC Primary production General

rules Protection against contamination Compliance with rules to control

hazards Cleanliness, use of water, use of

medicinal products, pesticides etc,

Record keeping Guides to good practice

Regulation 852/2004/EC

HACCP Procedure based on the HACCP principles

Arrangements to facilitate implementation by certain food businesses

Objective = control hazards Prerequisite requirements Critical Control Points Guides to good practice Documents and records

HACCP and Food Safety

What is HACCP?

Proven method used to ensure the safety of the foods „Systém in the Control Activities“

Originally developed for NASA space flights

Systematic approach that ensures food safety by looking at all processes as food “flows” through the processing plant

HACCP and Food SafetySeven principles of HACCP

Conduct a Hazard Analysis Identify Critical Control Points Establish Critical Limit Establish Monitoring Procedures of

CCP Establish Corrective Action Procedures Record Keeping Verification

HACCP and Food Safety

Seven principles of HACCP1. Analyse and Assess the Hazards

Review Operations2. Identify Critical Control Points

Where hazards can be prevented, eliminated, or reduced

3. Establish critical limits for each control point and preventive measures with Set Standards

Guidelines for all operations

HACCP and Food Safety4 Monitor Critical Control Points, Establish procedures to monitor the critical control points

• Verify proper procedures are being followed

5. Take Corrective Action, Establish corrective actions to be taken when monitoring shows a critical limit has not be met• Correct issues immediately6. Keep Records, Establish procedures to verify the system is working properly

• Temperature and Production Records7. Verify the System is Working, Establish effective recordkeeping to document HACCP system

• HACCP Review Team to verify

Relationship of GMPs, SOPs and HACCP

HACCP is not a stand alone system!

GMPs SOPs

HACCP

Regulation 853 /2004/EC

Food of Animal origin: A High level of protection “Hygiene II”: Rules for Food of Animal Origin

Re-cast of existing rules – no new elements Covers all food of animal origin, Covers all stages of production, processing

and distribution, including primary production Operators need authorisation Authorisation requires inspection Imports only allowed from listed

establishments

Regulation 853 /2004/ECFood of Animal origin:

Article 1 Scope1. This Regulation lays down specific rules on the

hygiene of food of animal origin for food business operators. These rules supplement those laid down by Regulation (EC) No 852/2004. They shall apply to unprocessed and processed products of animal origin.

2. Unless expressly indicated to the contrary, this Regulation shall not apply to food containing both products of plant origin and processed products of animal origin. However, processed products of animal origin used to prepare such food shall be obtained and handled in accordance with the requirements of this Regulation.

Regulation 853 /2004/ECFood of Animal origin

Article 1 Scope(1) 3. This Regulation shall not apply in relation to: (a) primary production for private domestic use;

(b) the domestic preparation, handling or storage of food for private domestic consumption;

(c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments

directly supplying the final consumer;


Article 4 Registration and approval of establishments

1. Food business operators shall place products of animal origin manufactured in the Community on the market only if they have been prepared and handled exclusively in establishments: (a) that meet the relevant requirements of

Regulation (EC) No 852/2004, those of Annexes II and III of this Regulation and other relevant requirements

of food law; and (b) that the competent authority has registered or,

where required in accordance with paragraph 2, approved.


Article 5 Health and identification marking 1. Food business operators shall not place on

the market a product of animal origin handled in an establishment subject to approval in accordance with Article 4(2) unless it has either:

(a) a health mark applied in accordance with Regulation (EC) No 854/2004; or

(b) when that Regulation does not provide for the application of a health mark, an identification mark applied in accordance with Annex II, Section I, of this Regulation.


ANNEX III SPECIFIC REQUIREMENTS SECTION I: MEAT OF DOMESTIC UNGULATES SECTION II: MEAT FROM POULTRY AND LAGOMORPHS SECTION III: MEAT OF FARMED GAME SECTION IV: WILD GAME MEAT SECTION V: MINCED MEAT, MEAT PREPARATIONS AND MECHANICALLY SEPARATED MEAT (MSM) SECTION VI: MEAT PRODUCTS SECTION VII: LIVE BIVALVE MOLLUSCS SECTION VIII: FISHERY PRODUCTS SECTION IX: RAW MILK, COLOSTRUM, DAIRY PRODUCTS AND COLOSTRUM-BASED PRODUCTS SECTION X: EGGS AND EGG PRODUCTS SECTION XI: FROGS' LEGS AND SNAILS SECTION XII: RENDERED ANIMAL FATS AND GREAVES SECTION XIII: TREATED STOMACHS, BLADDERS AND INTESTINES SECTION XIV: GELATINE SECTION XV: COLLAGEN


ANNEX I DEFINITIONS For the purpose of this Regulation: 1.1. ‘Meat’ means edible

parts of the animals ref. to in points 1.2 to1.8,including blood ANNEX II REQUIREMENTS CONCERNING SEVERAL

PRODUCTS OF ANIMAL ORIGIN ANNEX III SPECIFIC REQUIREMENTS SECTION I: MEAT OF DOMESTIC UNGULATES CHAPTER I: TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE CHAPTER II: REQUIREMENTS FOR SLAUGHTERHOUSES CHAPTER III: REQUIREMENTS FOR CUTTING PLANTS CHAPTER IV: SLAUGHTER HYGIENE CHAPTER V: HYGIENE DURING CUTTING AND BONING CHAPTER VI: EMERGENCY SLAUGHTER OUTSIDE THE SLAUGHTERHOUSE CHAPTER VII: STORAGE AND TRANSPORT SECTION II: MEAT FROM POULTRY AND LAGOMORPHS

Regulation 854/2004/EC

Harmonised instructions:Official Controls, Meat Inspection “Hygiene III”:

Controls for Food of Animal Origin Re-cast of existing provisions – no new elements Covers establishments with a risk of

contamination, in particular businesses producing meat, milk, eggs, fishery products and food containing such components

Detailed rules for inspections – what must be done

OFFICIAL CONTROLS 882/2004/EC

Official feed and food controls

Controls of food of animal origin

Audits of controls

Residue testing

Certification

IMPORTS GENERALArticle 10 of Regulation

852/2004The relevant requirements of food law include:

Detailed requirements for primary production

Detailed requirements after primary production

Microbiological/temperature criteria HACCP based procedures Registration/approval of establishments

Basic requirements food imports

Imported food must meet:

Requirements of EU food law or Conditions recognised by

Community as at least equivalent to EU law or

Special conditions as laid down in an SPS Agreement between EU and third country

Listing of third countries

Food of animal origin: YES Export Certifying Competent Authority

must be:- in compliance with O.I.E. International Animal Health

Code (Terrestrial and Aquatic) Code - independent on political, economical and social situation of

country shall have necessary infrastructure to be able to carry out check and controlsappropriate necessary leagally based competencies and power to stop export if food or products of animal origin to be exported are unsafed Food of non-animal origin: NO

Import checks

Food of animal origin: Via border inspection post Prior notice of arrival-

praenotification

Food of non animal origin In accordance with control plan At an appropriate place

Registration of food businesses

Food of animal origin: food businesses that are listed

Food of non-animal origin: importer must ensure safe origin of food

European Union and


EU

ANIMAL HEALTH

LEGISLATION

EUROPEAN UNION ANIMAL HEALTH

LEGISLATION COUNCIL DIRECTIVE 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ L 121, 29.7.1964, p. 1977)

Article 1 This Directive shall apply to intra-Community trade in bovine animals and swine Article 2 Definitions: (a) herd means an animal or group of animals kept on a holding as an

epidemiological unit; if more than one herd is kept on a holding, each of these herds shall form a distinct unit and shall have the same health status;

(d,e) officially tuberculosis-free bovine means a bovine herd which satisfies the conditions laid down in Annex A.I (g.h) officially brucellosis-free bovine herd means a bovine herd which

satisfies the conditions laid down in A.II (j,k) officially enzootic-bovine-leukosis-free means a herd which satisfies the conditions laid down in Annex D (l) official veterinarian means the veterinarian appointed by the competent authority of the Member State; (m) approved veterinarian means any veterinarian approved by the competent authority in accordance with the provisions of (n) compulsorily notifiable diseases means the diseases listed in Annex E (I);

COUNCIL DIRECTIVE 64/432/EEC of 26 June 1964 on animal health problems

affecting intra-Community trade in bovine animals and swine

ANNEX A I. Officially tuberculosis-free bovine herd II. Officially brucellosis-free and brucellosis-free bovine herds ANNEX B TUBERCULOSIS 1. IDENTIFICATION OF THE AGENT 2. THE TUBERCULIN SKIN TEST ANNEX C BRUCELLOSIS 1. IDENTIFICATION OF THE AGENT 2. IMMUNOLOGICAL TESTS

2.1. Standards 2.2. Immunolog. Tests ( ELISA ) 2.3. Complement fixation test (CFT) 2.4. Milk ring test (MRT) 2.5. Buffered Brucella antigen test (Rose Bengal test (RBT) 2.6. Serum agglutination test (SAT) 2.7. Fluorescence polarisation assay (FPA)

ANNEX D OFFICIALLY ENZOOTIC-BOVINE- LEUKOSIS-FREE HERDS,

MEMBER STATES AND REGIONS A. Agar gel immune-diffusion test for enzootic bovine leukosis B. Method for antigen standardization C. ELISA for detecting enzootic bovine leukosis

COUNCIL DIRECTIVE 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine ANNEX A I. Officially tuberculosis-free bovine herd 1. A bovine herd is officially tuberculosis-free if: (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 intra dermal tuberculin tests carried out in accordance with Annex the first six months after the elimination of any infection

from the herd and the second six months later or, where the herd has been assembled solely from

animals thatoriginate in officially tuberculosis-free herds, the first test shall be carried out at least 60 days after

assembly and the second shall not be required;

COUNCIL DIRECTIVE 64/432/EEC

of 26 June 1964 on animal health problems affecting intra-Community trade in bovine

animals and swine 1. A bovine herd is officially tuberculosis-free if:

(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 to an intradermal

tuberculin test performed and assessed according to Annex B and carried

out

either in the 30 days prior to, or the 30 days after the date of its introduction into the herd; in the latter case the animal(s) must be isolated physically from the other

animals of the herd in a way to avoid any direct or indirect contact with the other

animaluntil proven negative.

However, the competent authority may not require this test to be carrieout for movements of animals on its own territory if the animal is from anofficially tuberculosis-free herd

COUNCIL DIRECTIVE 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine 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.

COUNCIL DIRECTIVE 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine 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 postmortem examination.

3B. The officially tuberculosis-free status of the herd is to be withdrawn if the presence of tuberculosis is confirmed by the isolation of M. bovis on laboratory examination.

The competent authority may withdraw status if:

(a) the conditions detailed in point 2 are no longer fulfilled, or (b) classical lesions of tuberculosis are seen at post-mortem examination, (c) an epidemiological enquiry establishes the likelihood of infection, (d) or for any other reasons considered necessary for the purpose of controlling bovine tuberculosis.

COUNCIL DIRECTIVE 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swineANNEX A II. Officially brucellosis-free and brucellosis-free

bovine herds1. 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;

COUNCIL DIRECTIVE 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine1. A bovine herd is officially brucellosis-free if:

(2) (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 per ml when given a serum agglutination test in accordance with Annex C or

has reacted negatively to any other test approved in accordance with the procedure at Article 17 during the 30 days prior to or the

30 days after the date of its introduction into the herd:

In the latter case, the animal(s) must be isolated physically from the other animals of the herd in such a way as to avoid direct orindirect contact with the other animals until proven negative.

COUNCIL DIRECTIVE 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine 2. A bovine herd will retain officially brucellosis-

free status if: (a) one of the following test regimes is carried out annually with negative results in accordance with Annex C: (i) three milk ring tests carried out at intervals of at least three months; (ii) three milk ELISAs carried out at intervals of at least three months; (iii) two milk ring tests carried out at an interval of at least three months

followed at least six weeks later by a serological test (paragraph 10); (iv) two milk ELISAs carried out at an interval of at least three months

followed at least six weeks later by a serological test (paragraph 10); (v) two serological tests carried out at an interval of at least three months and not more than 12 months. (b) all bovine animals entering the herd come from herds of

officially brucellosis-free status and, in the case of bovine animals over 12 months old, have shown a brucella titre of less than 30 IU of agglutination per ml when given a serum agglutination

COUNCIL DIRECTIVE 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine 3A. The officially brucellosis-free status of a

herd is to be suspended if: (a) the conditions detailed in paragraphs 1 and 2 are

no longer fulfilled; or (b) as a result of laboratory tests or on clinical grounds one

or more bovine animals is suspected of having brucellosis and the suspect animals have been slaughtered or isolated in a way to avoid any direct or indirect contact with the other animals.

Where the animal has been slaughtered and is no longer available for testing, the suspension may be lifted if two serum agglutination tests, carried out in accordance with Annex C on all bovine animals in the herdover 12 months old, show a titre lower than 30 IU of agglutination perml. The first test shall be carried out at least 30 days after the

removal of the animal and

the second at least 60 days later.



animals and swine 3B. The officially brucellosis-free status of the herd is to be withdrawn if,

As a result of laboratory tests or epidemiological investigations, brucella infection has been confirmed in the herd.

The status of the herd is not to be restored until either all bovine animals present in the herd at the time

of the outbreak have been slaughtered, or the herd has been subject to check testing and all

animals over 12months of age have given negative results to two consecutive tests at 60-day intervals, the first being carried out not less than 30 days

afterremoval of the positive animal(s).



animals and swine 4. A bovine herd is brucellosis-free if it complies

with the conditions in 1(b) and (c) and when vaccination has been carried out as follows:

(i) female bovine animals have been vaccinated: — before the age of six months old with live strain 19 vaccine,

or — before the age of 15 months old with killed 45/20 adjuvant

vaccine which has been officially inspected and approved, or — with other vaccines approved under the procedure laid down

in Article 17; (ii) bovine animals under 30 months old which have been

vaccinated with live strain 19 vaccine may give a serum agglutination test result greater than 30 IU but less than 80 IU of agglutination per millilitre provided that, on the complement fixation test, they give a result less than 30 EEC units in the case of females vaccinated less than 12 months previously or less than 20 EEC units in all other cases.

COUNCIL DIRECTIVE 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine 5. A bovine herd will retain brucellosis-free

status if: (i) it is subject to one of the testing regimes listed in

2(a); (ii) bovine animals entering the herd comply with the

requirements of 2(b); or — come from herds of brucellosis-free status, and in the case of bovine animals over 12 months old, have shown, in the 30 days prior to or in isolation after introduction into the herd, less than 30 IU of agglutination per ml when given a serum agglutination test and a negative result to a complement fixation test in accordance with Annex C, or — come from herds of brucellosis-free status, are under 30 months old and have been vaccinated with live strain 19 vaccine if they give a serum agglutination test result greater than 30 IU but less than 80 IU of agglutination per millilitre provided that, on the complement fixation test, they give a result less than 30 EEC units in the case of females vaccinated less than 12 months previously or less than 20 EEC units in all other cases.

COUNCIL DIRECTIVE 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine

6A. The brucellosis-free status of a herd is to be suspended if:

(a) the conditions detailed in paragraphs 4 and 5 have not been complied with; or

(b) as a result of laboratory tests or on clinical grounds one or more bovine animals over 30 months old is suspected of having

brucellosis and the animal(s) under suspicion have been slaughtered, or isolated in a way to avoid any direct or indirect contact with other animals.

Where the animal has been isolated, it may be reintroduced into the herd and the status of the herd may be restored, if it subsequently shows a serum agglutination titre lower than 30 IU

of agglutination per ml and has given a negative result to a complement fixation test, or other

test approved under the procedure set out in Article 17. Where the animals have been slaughtered and are no longer

available for testing, the suspension may be lifted if two serum agglutination tests, carried out in accordance with Annex

C on all bovine animals in the holding over 12 months old, show a titre lower than 30 IU of agglutination per ml.

The first test is to be carried out at least 30 days after the removal of the animal and the second at least 60 days later.


6B. The brucellosis-free status of the herd is to be withdrawn if,

as a result of laboratory tests of epidemiological investigations, brucella infection has been confirmed in a herd.

The status of the herd is not to be restored until either all the bovine animals present in the herd at the time of the outbreak have been slaughtered or the herd has been subject to check testing and all unvaccinated animals over

12 months of age have given negative results to two consecutive tests at 60 day intervals,

the first being carried out not less than 30 days after removal of the positive animal(s).

If all the animals to be tested referred to in the preceding paragraph are less than 30 months old and have been vaccinated with

live strain 19 vaccine, they may be considered negative if they show a brucella titre of more than 30 IU but less than 80 IU of

agglutination per ml, provided that in the complement fixation test they show a titre of less than 30 EEC units in the case of females vaccinated less than 12 months previously or

a titre of less than 20 EEC units in all other cases. In the case of bovine animals which were pregnant at the time of the

outbreak, the final check must have been carried out at least 21 days after the last animal pregnant at the time of the outbreak has calved.

COUNCIL DIRECTIVE 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine 7. A Member State or a region of a Member

State may be declared officially brucellosis-free according to the procedure laid down in Article 17 if it meets the following conditions:

(a) no case of abortion due to brucella infection and no isolation of B. abortus has been recorded for at least three years and at least 99,8 % of herds have achieved officially brucellosis-free status each year for five consecutive years, the calculation of this percentage to také place on 31 December each calendar year.

(b) each bovine animal is identified in accordance with Community legislation, and

(c) notification of cases of abortion is mandatory and they are investigated by the competent authority.


8. Member State or a region of a Member State declared officially brucellosis-free is to retain this status if:

(a) the conditions imposed by paragraph 7(a) and (b) are still fulfilled and notification of cases of abortion suspected of being due to brucellosis is mandatory and are investigated by the competent authority; (b) every year for the first five years after attaining status, all bovine animals over 24 months of age in not less than 20 % of herds have been tested and have reacted negatively to a serological test ( Annex C), (c) every bovine animal suspected of being infected with brucellosis is notified to the competent authority and undergoes official epidemiological investigation (d) during the period of suspicion, which is to continue until negative results have been obtained from the tests provided for in (c), the officially brucellosis-free status of the herd of origin or transit of the suspected bovine animal and of the herds linked epidemiologically to it is to be suspended; (e) in the event of an outbreak of brucellosis that has spread, all bovine animals have been slaughtered. Animals of the remaining susceptible species will undergo appropriate tests and premises and equipment will be cleaned and disinfected.

Animal Diseases - Eradication and Monitoring Programmes -

Legislation COUNCIL DIRECTIVE of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra- Community trade in certain live animals and products with a view to the completion of the internal market (90/425/EEC)

COUNCIL DIRECTIVE 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryo not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC

COUNCIL DECISION of 26 June 1990 on expenditure in the veterinary field (90/424/EEC)

Animal Diseases Legislation COUNCIL DIRECTIVE 90 /425

Article 1 Member States shall ensure that the veterinary checks

to be carried out on live animals and products which are covered by the Directives listed in Annex A or on those referred to in the first paragraph of Article 21 and which are intended for trade are no longer carried out, without prejudice to Article 7, at frontiers but are carried out iaccordance with this Directive.

Article 7 measures taken at the BIP (a) certificates or documents accompanying the

animals and products are checked; (b) Community animals and products shall be subject

to the controlrules laid down in Article 5;

Animal Diseases Legislation COUNCIL DECISION (90/424/EEC) on expenditure in the veterinary field

Article 1 This Decision lays down the procedures governing the Community's financial contribution towards:

— specific veterinary measures,

— inspection measures in the veterinary field,

— programmes for the eradication, control and monitoring of animal diseases and zoonoses.

Animal Diseases Legislation COUNCIL DECISION (90/424/EEC) on expenditure in the veterinary field

Article 2 Specific veterinary measures shall include: — emergency measures; — the campaign against foot-and-mouth disease, — measures for the protection of animals, — contribution to national schemes for the eradication of certain diseases, — technical and scientific measures.

Article 3 Emergency measures 1. The provisions of this Article shall apply in the event of the occurrence of one of the following diseases in the territory of a Member State: — rinderpest cattle plague, — sheep and goat plague, — swine vesicular disease, — blue tongue, — Teschen disease,

2006/965/EC: Council Decision amending Decision 90/424/EEC on expenditure in the veterinary field – extent to zoonosis

COUNCIL DIRECTIVE 92/65/EEC on animal health requirements governing trade in and imports

into the Community of animals, semen, ova and embryo not subject to animal health requirements laid down in specific

Community rules referred to in Annex A (I) to Directive 90/425/EEC Article 1 This Directive lays down the animal health

requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC.

Article 3 The Member States shall ensure that the trade is not prohibited or restricted for animal health reasons other than those arising from the application of this Directive or fromCommunity legislation, and in particular any safeguard measures taken.

This Directive shall not affect the national rules applicable to pet animals, although their retention may not jeopardize the abolition of veterinary checks at the frontiers between Member States

ANNEX A NOTIFIABLE DISEASES IN THE CONTEXT OF THIS DIRECTIVE

ANNEX B LIST OF DISEASES FOR WHICH NATIONAL PROGRAMMES MAY BE RECOGNIZED UNDER THIS DIRECTIVE

Council Directive 2005/94/EC 2005 on Community measures for the control of avian

influenza and repealing Directive 92/40/EEC

Article 1 Subject matter and scope

1. This Directive sets out:

(a) certain preventive measures relating to the surveillance and the early detection of avian influenza and increasing the level of the competent authorities' and the farming community's awareness of,and preparation for, the risks of that disease;

(b) the minimum control measures to be applied in the event of an outbreak of avian influenza in poultry or other captive birds and the early detection of possible spread of avian influenza viruses tomammals;

(c) other subsidiary measures to avoid the spread of influenza viruses of avian origin to other species.

2. Member States shall remain free to take more stringent measuresin the field covered by this Directive.

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 (OJ L 325, 12.12.2003, p. 31)

Article 1 Subject matter and scope 1. The purpose of this Directive is to ensure that

zoonoses, zoonotic agents and related antimicrobial resistance are properly monitored, and that

food-borne outbreaks receive proper epidemiological investigation, to enable the collection in the Community of the information necessary to evaluate relevant trends and sources.

2. This Directive covers: (a) the monitoring of zoonoses and zoonotic agents; (b) the monitoring of related antimicrobial resistance; (c) the epidemiological investigation of food-borne

outbreaks; and (d) the exchange of information related to zoonoses

and zoonotic agents.

COUNCIL DIRECTIVE 2000/75/EC

laying down specific provisions for the control and eradication of bluetongue (OJ L 327, 22.12.2000, p. 74) Article 1 This Directive lays down control rules

and measures to combat and eradicate bluetongue.

Article 2 Definitions: (a) ‘holding’: agricultural or other establishment where

animals of species susceptible to bluetongue are permanently or temporarily reared or kept;

(b) ‘susceptible species’: all ruminants; (e) ‘vector’: an insect of the species Culicoides imicola

or any other insect of the genus Culicoides capable of transmitting bluetongue, to be identified according to the procedure laid down in Article 20(2), on the advice of

the Scientific Veterinary Committee;

REGULATION (EC) No 999/2001 laying down rules for the prevention, control and

eradication of certain transmissible spongiform Encephalopathies

(OJ L 147, 31.5.2001, p. 1) Article 1 Scope 1. This Regulation lays down rules for the prevention, control and

eradication of transmissible spongiform encephalopathies (TSEs) in animals.

It shall apply to the production and placing on the market of live animals and products of animal origin and in certain specific cases to exports thereof.

Article 7 Prohibitions concerning animal feeding

1. The feeding to ruminants of protein derived from animals shall be prohibited.

2. The prohibition provided for in paragraph 1 shall be extended to animals other than ruminants and restricted,

as regards the feeding of those animals with products of animal origin, in accordance with Annex IV.

REGULATION (EC) No 999/2001 laying down rules for the prevention, control and

eradication of certain transmissible spongiformmEncephalopathies

(OJ L 147, 31.5.2001, p. 1) Article 8 Specified risk material

1. The specified risk material shall be removed and disposed of in accordance with Annex V to this Regulation and with Regulation (EC) No 1774/2002.

It shall not be imported into the Community. The list of specified risk material referred to in

Annex V shall include at least the brain, spinal cord, eyes and tonsils of bovine animals aged over 12 months and the vertebral column of bovine animals above an age to be determined in accordance with the procedure referred to in Article 24(3).

Taking into account the different risk categories laid down in the first subparagraph of Article 5(1) and the requirements of Article 6(1a) and (1b) (b), the list of specified risk material in Annex V shall be amended accordingly.

Documentation on the web site

General Information:http://eur-lex.europa.eu/

http://europa.eu.int/comm/food/index_en.htm

Food and Feed Law:http://europa.eu.int/comm/food/food/controls/foodfeed/index_en.htm

Food and Veterinary Office:http://europa.eu.int/comm/food/fvo/index_en.html

Animal Welfare:http://europa.eu.int/comm/food/animal/welfare/index_en.htm

Rapid Alert System Publications:http://europa.eu.int/comm/food/rapidalert/index_en.html

TRADE: http://export-help.cec.eu.int/

http://eur-lex.europa.eu/

http://eur-lex.europa.eu/

http://europa.eu.int/comm/food/

http://europa.eu.int/comm/dgs/health_consumer/index_en.htm

http://europa.eu.int/comm/food/food/controls/foodfeed/

http://europa.eu.int/comm/dgs/health_consumer/index_en.htm

http://europa.eu.int/comm/food/fvo/index_en.html

http://europa.eu.int/comm/food/animal/welfare/index_en.htm

http://europa.eu.int/comm/food/rapidalert/index_en.html

Documentation on the web site

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