
REGULATION (EC) No 854/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (repealed) 

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CHAPTER I
GENERAL PROVISIONS
Scope
Article 1 
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Definitions
Article 2 
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CHAPTER II
OFFICIAL CONTROLS IN RELATION TO COMMUNITY ESTABLISHMENTS
Approval of establishments
Article 3 
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General principles for official controls in respect of all products of animal origin falling within the scope of this Regulation
Article 4 
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Fresh meat
Article 5 
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Live bivalve molluscs
Article 6 
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Fishery products
Article 7 
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Raw milk and dairy products
Article 8 
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Action in the case of non-compliance
Article 9 
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CHAPTER III
PROCEDURES CONCERNING IMPORTS
Article 10 
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Lists of third countries and parts of third countries from which imports of specified products of animal origin are permitted
Article 11 
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List of establishments from which imports of specified products of animal origin are permitted
Article 12 
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Live bivalve molluscs, echinoderms, tunicates and marine gastropods
Article 13 
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Documents
Article 14 
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Special provisions for fishery products
Article 15 
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CHAPTER IV
FINAL PROVISIONS
Article 16 
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Amendment and adaptation of the Annexes
Article 17 
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Specific decisions
Article 18 
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Committee procedure
Article 19 
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Consultation of the European Food Safety Authority
Article 20 
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Report to the European Parliament and to the Council
Article 21 
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Entry into force
Article 22 
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ANNEX I
FRESH MEAT
SECTION I:
TASKS OF THE OFFICIAL VETERINARIAN
CHAPTER I:
AUDITING TASKS
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. In addition to the general requirements of Article 4(5) concerning audits of HACCP-based principles, the official veterinarian is to check that the operators' procedures guarantee, to the extent possible, that meat: 

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CHAPTER II:
INSPECTION TASKS
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A. Food chain information 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B. Ante-mortem inspection 
 1. Subject to paragraphs 4 and 5: 

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 2. Ante-mortem inspection must in particular determine whether, as regards the particular animal inspected, there is any sign: 

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 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

C. Animal welfare 

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D. Post-mortem inspection 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. Additional examinations are to take place, such as palpation and incision of parts of the carcase and offal and laboratory tests, whenever considered necessary: 

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 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

E. Specified risk material and other animal by-products 

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F. Laboratory testing 
 1. The official veterinarian is to ensure that sampling takes place and that samples are appropriately identified and handled and sent to the appropriate laboratory within the framework of: 

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 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER III:
HEALTH MARKING
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. The official veterinarian is to ensure, in particular, that: 

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3. The health mark must be an oval mark at least 6,5 cm wide by 4,5 cm high bearing the following information in perfectly legible characters: 

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4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION II:
ACTION FOLLOWING CONTROLS
CHAPTER I:
COMMUNICATION OF INSPECTION RESULTS
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER II:
DECISIONS CONCERNING FOOD CHAIN INFORMATION
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. When the accompanying records, documentation or other information shows that: 

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5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER III:
DECISIONS CONCERNING LIVE ANIMALS
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER IV:
DECISIONS CONCERNING ANIMAL WELFARE
1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5. When: 

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CHAPTER V:
DECISIONS CONCERNING MEAT
1. Meat is to be declared unfit for human consumption if it: 

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2. The official veterinarian may impose requirements concerning the use of meat derived from animals: 

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SECTION III:
RESPONSIBILITIES AND FREQUENCY OF CONTROLS
CHAPTER I:
OFFICIAL AUXILIARIES
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CHAPTER II:
FREQUENCY OF CONTROLS
1. The competent authority is to ensure that at least one official veterinarian is present: 

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2. However, the competent authority may adapt this approach in certain slaughterhouses and game handling establishments identified on the basis of a risk analysis and in accordance with criteria laid down in accordance with Article 18, point 3, if there are any. In such cases: 

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3. The flexibility provided for in paragraph 2 does not apply: 

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4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER III:
INVOLVEMENT OF SLAUGHTERHOUSE STAFF
A. SPECIFIC TASKS CONCERNING THE PRODUCTION OF MEAT FROM POULTRY AND LAGOMORPHS 

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B. SPECIFIC SAMPLING AND TESTING TASKS 

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CHAPTER IV:
PROFESSIONAL QUALIFICATIONS
A. OFFICIAL VETERINARIANS 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. The competent authority must make arrangements for the test. The test is to confirm knowledge of the following subjects to the extent necessary depending on the veterinarian's background and qualifications: 

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 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B. OFFICIAL AUXILIARIES 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. The competent authority must make arrangements for such tests. To be eligible for these tests, candidates must prove that they have received: 

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 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. Training for official auxiliaries is to cover, and tests are to confirm knowledge of, the following subjects: 

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 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SECTION IV:
SPECIFIC REQUIREMENTS
CHAPTER I:
DOMESTIC BOVINE ANIMALS
A. BOVINE ANIMALS UNDER SIX WEEKS OLD 

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B. BOVINE ANIMALS OVER SIX WEEKS OLD 

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CHAPTER II:
DOMESTIC SHEEP AND GOATS
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CHAPTER III:
DOMESTIC SOLIPEDS
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CHAPTER IV:
DOMESTIC SWINE
A. ANTE-MORTEM INSPECTION 
 1. The competent authority may decide that pigs intended for slaughter are to be submitted to ante-mortem inspection at the holding of provenance. In that case, slaughter of a lot of pigs from a holding may be authorised only if: 

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 2. Ante-mortem inspection at the holding of provenance is to comprise: 

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 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4. Ante-mortem inspection at the slaughterhouse need cover only: 

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 5. When pigs are not slaughtered within three days of the issue of the health certificate provided for in paragraph 1(a): 

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B. POST-MORTEM INSPECTION 
 1. Carcases and offal of pigs are to undergo the following post-mortem inspection procedures: 

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 2. The official veterinarian shall proceed with additional post-mortem inspection procedures using incision and palpation of the carcase and offal, where, in his or her opinion, one of the following indicates a possible risk to public health, animal health or animal welfare: 

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 3. Depending on the identified risks, the additional post-mortem procedures referred to in point 2 may include: 

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CHAPTER V:
POULTRY
A. ANTE-MORTEM INSPECTION 
 1. The competent authority may decide that poultry intended for slaughter are to be submitted to ante-mortem inspection at the holding of provenance. In that case, slaughter of a flock of birds from a holding may be authorised only if: 

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 2. Ante-mortem inspection on the holding of provenance is to comprise: 

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 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 4. Ante-mortem inspection at the slaughterhouse need only cover: 

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 5. When birds are not slaughtered within three days of the issue of the health certificate referred to in paragraph 1(a): 

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 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B. Post-mortem inspection 
 1. All birds are to undergo post-mortem inspection in accordance with Sections I and III. In addition, the official veterinarian is personally to carry out the following checks: 

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 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

C. SPECIMEN HEALTH CERTIFICATE 

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CHAPTER VI:
FARMED LAGOMORPHS
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CHAPTER VII:
FARMED GAME
A. Ante-mortem inspection 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3. When ante-mortem inspection takes place no more than three days before the arrival of the animals at the slaughterhouse, and animals are delivered to the slaughterhouse live, ante-mortem inspection at the slaughterhouse need only cover: 

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 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B. Post-mortem inspection 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER VIII:
WILD GAME
A. Post-mortem inspection 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2a. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3. During post-mortem inspection, the official veterinarian is to carry out: 

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 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

B. Decisions following controls 

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CHAPTER IX:
SPECIFIC HAZARDS
A. Transmissible spongiform encephalopathies 

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B. Cysticercosis 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

C. Trichinosis 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

D. Glanders 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

E. Tuberculosis 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F. Brucellosis 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

G. Salmonella 
 1. Without prejudice to the first paragraph of Article 1 to Commission Regulation (EC) No 2073/2005, the competent authority shall verify the correct implementation by food business operators of the point 2.1.4 (process hygiene criterion for Salmonella on pig carcases) of Annex I to that Regulation by applying the following measures: 

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 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER X:
SPECIMEN HEALTH CERTIFICATE
A. SPECIMEN HEALTH CERTIFICATE FOR LIVE ANIMALS 

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B. SPECIMEN HEALTH CERTIFICATE FOR ANIMALS SLAUGHTERED AT THE HOLDING 

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C. SPECIMEN HEALTH CERTIFICATE FOR FARMED GAME SLAUGHTERED AT THE HOLDING in accordance with point 3a of Section III of Annex III to Regulation (EC) No 853/2004. 

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ANNEX II
LIVE BIVALVE MOLLUSCS
CHAPTER I:
SCOPE
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CHAPTER II:
OFFICIAL CONTROLS CONCERNING LIVE BIVALVE MOLLUSCS FROM CLASSIFIED PRODUCTION AREAS
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A. CLASSIFICATION OF PRODUCTION AND RELAYING AREAS 
 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 3. The competent authority may classify as being of Class A areas from which live bivalve molluscs may be collected for direct human consumption. Live bivalve molluscs placed on the market from these areas must meet the health standards laid down in Annex III, Section VII, Chapter V, of Regulation (EC) No 853/2004. 

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 4. The competent authority may classify as being of Class B areas from which live bivalve molluscs may be collected and only placed on the market for human consumption after treatment in a purification centre or after relaying so as to meet the health standards referred to in paragraph 3. Live bivalve molluscs from these areas must not exceed, in 90 % of the samples, 4 600E. coli per 100 g of flesh and intravalvular liquid. In the remaining 10 % of samples, live bivalve molluscs must not exceed 46 000E. coli per 100 g of flesh and intravalvular liquid. 

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 6. If the competent authority decides in principle to classify a production or relaying area, it must: 

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B. MONITORING OF CLASSIFIED RELAYING AND PRODUCTION AREAS 
 1. Classified relaying and production areas must be periodically monitored to check: 

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 3. Sampling plans to check the microbiological quality of live bivalve molluscs must take particular account of: 

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 4. Sampling plans to check for the presence of toxin-producing plankton in production and relaying waters and for biotoxins in live bivalve molluscs must take particular account of possible variations in the presence of plankton containing marine biotoxins. Sampling must comprise: 

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C. DECISIONS AFTER MONITORING 
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D. ADDITIONAL MONITORING REQUIREMENTS 
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E. RECORDING AND EXCHANGE OF INFORMATION 

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F. FOOD BUSINESS OPERATORS' OWN CHECKS 

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CHAPTER III:
OFFICIAL CONTROLS CONCERNING PECTINIDAE, MARINE GASTROPODS AND ECHINODERMS WHICH ARE NOT FILTER FEEDERS HARVESTED OUTSIDE CLASSIFIED PRODUCTION AREAS
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ANNEX III
FISHERY PRODUCTS
CHAPTER I:
OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET
1. Official controls on the production and placing on the market of fishery products are to include, in particular: 

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2. However, subject to paragraph 3, official controls of vessels: 

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CHAPTER II:
OFFICIAL CONTROLS OF FISHERY PRODUCTS
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A. ORGANOLEPTIC EXAMINATIONS 

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B. FRESHNESS INDICATORS 

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C. HISTAMINE 

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D. RESIDUES AND CONTAMINANTS 

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E. MICROBIOLOGICAL CHECKS 

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F. PARASITES 

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G. POISONOUS FISHERY PRODUCTS 

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CHAPTER III:
DECISIONS AFTER CONTROLS
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ANNEX IV
RAW MILK, COLOSTRUM, DAIRY PRODUCTS AND COLOSTRUM BASED PRODUCTS
CHAPTER I:
CONTROL OF MILK AND COLOSTRUM PRODUCTION HOLDINGS
1. Animals on milk and colostrum production holdings must be subject to official controls to verify that the health requirements for raw milk and colostrum production, and in particular the health status of the animals and the use of veterinary medicinal products, are being complied with. 

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CHAPTER II:
CONTROL OF RAW MILK AND COLOSTRUM UPON COLLECTION
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ANNEX V
ESTABLISHMENTS NOT SUBJECT TO THE LISTING REQUIREMENT OF ARTICLE 12(1)

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ANNEX VI
REQUIREMENTS FOR CERTIFICATES ACCOMPANYING IMPORTS

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