MVDr. Josef Holejšovský, Ph.D. Institut of Tropics and Subtropics

European Union Veterinary legislation Animal Health and Food Safety Control
MVDr. Josef Holejšovský, Ph.D. Institut of Tropics and Subtropics Czech University of Life Sciences Prague

European Union and Veterinary Legislation
Developpment of Cmmunity Veterinary Legislatin

EU Veterinary Legislation
Developpment of EU Veterinary Legislation 1. In 1957 the Rome Treaty signed and the EEC created 2.Common Agar Policy became the most important issue regarding the food supply independence 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.

EU Veterinary Legislation
Developpment of EU Veterinary Legislation 5. In 1964 first veterinary directives adopted- Council Directives 64/432 and 64/433/EEC laing down requirements concerning animal healths and and food safety for intacommunity 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

Developpment of EU Veterinary Legislation
7. In 1987 – European Single Market Act- the most productive period as for the Veterinary legislation began. 8. In 1988 Strategic Document – basis for preparation of veterinary legislation leading towards full harmonisation till the end of 1992 (Mastricht Treaty on EU) .

Main Points of Strategic Document:
full harmonization of veterinary legislaton over the whole territory of EU Member States the same status as for the animal and public health in all MS at highest level possible clasification of diseases in compliance with their importance for animal and human health new systeme of control and supervision new health safety definition- principle of regionalization

Institutions of the European Union involved in Legal Process
The European Court of Justice The European Commission The European Parliament European Investment Bank Institutions of the European Union involved in Legal Process Goal Goal The Council of the European Union European Court of auditors Economic and Social Committee Committee of the Regions European Ombudsman

Institutions of the European Union Involved 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 EU as a whole

The EU Legislative Process
. Initiative Consultation Decision making European Parliament Council of Ministers European Commission

Legal Instruments Regulation Directive Decisions
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 Directives
91/492 91/493 91/494 91/495 92/45 92/46 92/48 94/65 93/43 64/433 71/118 72/461 77/96 77/99 80/215 89/362 89/437

Which are covering Egg Products Hygiene of foodstuffs Bivalve molluscs
Fishery products Fishing vessels Poultymeat - 3rd Milk & MilkProduction Rabbit and game Wild game Hygiene of foodstuffs Fresh meat Fresh Poultry meat Pigmeat 3r Countries Meat Products Animal Health/meat Minced Meat

Developpement of the New EU Food Legislation From Green Paper towards the Food Law
Presents Food Safety Issues to Citizens and Institutions for public discussion White Paper on Food Safety Defined Food Safety Policy and its Principles based on Discussion Results iniciated ba 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

Green Paper of the EU On Food Legislation On its Comprehancivness
Foccused : On Food Legislation On its Comprehancivness On Lacks and Shortcommings in Food Legislation, Transparency and Consistency Identifies Nonharmonized Legislation Areas leading to Trade Barriers Identifies 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 EU food law is divided in 5 relevant regulations The General food law lays down the principles that I have briefly outlined before. Hygiene 1 brings to live the principles outlined before. Hygiene 2 adds rules for food of animal origin and Hygiene 3 outlines the task of competent authority with regard to food of animal origin.

New EU Food Legislation 17

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 2 Definition of ‘food’
For the purposes of this Regulation, ‘food’ (or ‘foodstuff’) means: any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. ‘Food’ includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. It includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC

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;

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 Severity of hazard Risk perception
(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 Assessment Scientifically Based Risk Assessment Risk Communication Risk Communication Risk Management Legally based

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 LAW
lays 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. The EU has recast its legislation on food. The last parts of the new legislation will come into force 1 January This change has been triggered because Food Industry and objectives of old EU Food safety have changed in the 60-80thies. Also EU consumers got more concerned about the safety of their food, due to several food crises in the 90thies of last century. The EU responded by recasting its food laws, that should fundamentally address consumers' legitimate concerns in this regard with a view to restoring and maintaining confidence in food safety.“ One of the most striking examples of this is the EU approach of BSE, that I will touch upon at the end of this presentation. As an expample

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 Independent Risk Analysis: Scientific body EFSA Risk management: COM proposes, MS decide. EU Legal system of Comitology that may look complex, but is a very efficient mechanism capable of swift reactions to emerging crises. The rapid alert system for feed and food foresees obligatory notification of any direct or indirect risk to human health, animal health or the environment within a network consisting of national competent authorities, the EFSA and the European Commission. Weekly reports are published and widely read by the food sector, in particular in trade and processing businesses. Repeated notifications of individual countries of establishments can bear severe economic consequences. For example, Chilli powder may be found contaminated with red dye in a routine test in one Member State. Being informed via the Rapid Alert, all authorites can immediately check whether they have the same product on the market. Market forces are very important to supplement authorities in enforcing food safety. Reports from the rapid alert system are published weekly, and traders/retailers react to these reports - maybe even more quickly than authorities do. An establishment with repeated contamination problems reported via the Alert System may quickly find itself without a market to sell its products. Participation in the rapid alert system is in principle open, but subject to negotiated agreements. The Advisory Group on the Food Chain and Animal and Plant Health brings together notably consumers, the food industry, retailers and farmers for consultation and dialogue on food safety policy. It will meet at least twice a year Additionally, the Commission regularly uses Internet based means of consultation and will create an Internet forum on food safety. Debate and dialogue with stakeholders helps strengthen the quality of our policy making and is an essential component of good governance. The new Advisory Group replaces five existing consultative bodies. One example for this consultation process is our Discussion Paper on residues. Comments are now being evaluated. Striking the right balance between precaution and user needs Problem of « zero » tolerances for prohibited substances Using the ALARA Principle (as low as reasonably achievable) Problem of Minimum Required Performance Levels (MRPLs)

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 Simplification in comparaison with old situation that was scatterd over a lot of vertical directives and had numerous national laws as well. Now harmonised legislation. I will go into somewhat more detail on HACCP later during this presentation. Producer is responsible, Competent authority verifies. Next slides give a summary of of producers responibilties

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/EC on Food Hygiene
Introduces General Hygienic principles and requirements for all food (of plant and animal origin)

Regulation 852/2004/EC Legal 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 Hygiene 1 takes to live the outlined principles of food safety. It applies to all “food business operators” throughout the food chain and including primary production – farm to fork. So it includes primary producers: farmers and Fishermen It simplifies existing legislation and allocates clear responsibilities to all actors; All operators must implements HACCP Principles Now, all food business operators are responsible to introduce these principles and provide the necessary evidence of this introduction (i.e; documentation) to competent authorities. Operators must notify authorities of their activity and for certain activities with food of animal origin their approval is necessary. Guides of good practice will be developed. Implementing rules in preparation: Composite foods are still a problem: Soups, pre-cooked meals, canned food No disruption of existing trade

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 Instead of making too specific provisions, the Regulation remains general, in order to be widely applicable. Food and production facilities must remain clean and free of contamination. Only drinking water may come into contact with food. All surfaces and equipment must be easy to clean and so forth. Operators must retain records of measures relating to the control of hazards. For example, farmers must record feed used and its source, any disease and treatments. So, producers of composite foods not necessarily have to be approved (and listed), but they must source their ingredients (if from animal origin) from listed establishments. The Regulation provides also rules for wrapping and packaging.

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 Hazard Analysis and Critical Control Points (HACCP) principles prescribed by CODEX Alimentarius are introduced. Food business procedures have to based on HACCP. The HACCP principles are: - to identify any hazards - to identify the critical control points - to establish critical limits at critical control points - establish and implement effective monitoring procedures - establish corrective action - to establish procedures to verify - to establish documents and records Food business operators have to have there procedure based on HACCP principles and be able to indenty and control hazards. It is however not a certification requirement.

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

Seven principles of HACCP
HACCP and Food Safety Seven 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

Seven principles of HACCP
HACCP and Food Safety Seven principles of HACCP Analyse and Assess the Hazards Review Operations Identify Critical Control Points Where hazards can be prevented, eliminated, or reduced Establish critical limits for each control point and preventive measures with Set Standards Guidelines for all operations

HACCP and Food Safety 4 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 immediately 6. Keep Records, Establish procedures to verify the system is working properly Temperature and Production Records 7. 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! HACCP GMPs SOPs

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/EC Food of Animal origin:
Article 1 Scope 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/EC Food 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 unclear distribution of administrative competences and responsibility for inspections are frequently a major problem to implement improved hygiene standards. The inspection authority may not have the authority to impose sanctions, or some aspects are totally neglected because competences are unclear. One goal of our integrated food law "from farm to fork" has been to address this problem. Inspections throughout the food chain are further harmonised by the last legislative part of our food policy the Offical feed and food control regulation.

IMPORTS GENERAL Article 10 of Regulation 852/2004
The 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 This article specifies the import conditions for products of animal origin

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 The principle is simple. What we import has to comply with our food safety legislation

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 Neither for products of animal origin, nor for fruit and vegetables, nor for composite foods the new rules change the situation dramatically General hygiene rules were in place (Dir. 93/43/EC) Specific Hygiene Rules have not changed Inspection and controls have not changed Commission takes more responsibility for coherence The new rules will offer new opportunities for third countries, but this needs some time

Import checks Via border inspection post
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 Food of animal origin (article 14): Border inspection checks Directive 97/78/EC Nothing new: entry via border inspection posts (BIP), advance warning, documentary, identity, physical check (Commission Decision 94/360/EC)

ANIMAL HEALTH LEGISLATION 70

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, , 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 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 animal until proven negative. However, the competent authority may not require this test to be carrie out for movements of animals on its own territory if the animal is from an officially 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 swine ANNEX A II. Officially brucellosis-free and brucellosis-free bovine herds 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 swine 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 or indirect 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.

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

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

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

COUNCIL DIRECTIVE 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine 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 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, , 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, , 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, , 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, , 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: Food and Feed Law: Food and Veterinary Office: Animal Welfare: Rapid Alert System Publications: TRADE:

Documentation on the web site
EURLEX ADDRESSES

Web sites of the EU- (EC) 852, 853, 854 /2004 as Publisher The 30 th Apríl 2004 -Corrigenda to Regulations (EC) 852, 853, 854 / 2004

BENI DINLEDIGINIZ ICIN
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MVDr. Josef Holejšovský, Ph.D. Institut of Tropics and Subtropics

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