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- Point in Time (29/07/2011)
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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specific rules for the organisation of official controls on products of animal origin intended for human consumption (repealed)
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Editorial Information
X1 Substituted by Corrigendum to 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 (Official Journal of the European Union L 139 of 30 April 2004).
does not contain patho-physiological abnormalities or changes;
does not bear faecal or other contamination;
and
does not contain specified risk material, except as provided for under Community legislation, and has been produced in accordance with Community legislation on TSEs.
When carrying out inspection tasks in accordance with this Chapter, the official veterinarian is to take account of the results of the auditing tasks carried out in accordance with Article 4 and Chapter I of this Annex. Where appropriate he or she is to target inspection tasks accordingly.
the official veterinarian is to carry out an ante-mortem inspection of all animals before slaughter;
that inspection must take place within 24 hours of arrival at the slaughterhouse and less than 24 hours before slaughter.
In addition, the official veterinarian may require inspection at any other time.
that welfare has been compromised;
or
[F1of any condition which might adversely affect human or animal health, paying particular attention to the detection of zoonotic diseases and animal diseases for which animal health rules are laid down in Union legislation.]
Textual Amendments
F1 Substituted by Commission Implementing Regulation (EU) No 739/2011 of 27 July 2011 amending Annex I to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of officials controls on products of animal origin intended for human consumption (Text with EEA relevance).
The official veterinarian is to verify compliance with relevant Community and national rules on animal welfare, such as rules concerning the protection of animals at the time of slaughter and during transport.
to reach a definitive diagnosis;
or
to detect the presence of:
an animal disease,
residues or contaminants in excess of the levels laid down under Community legislation,
non-compliance with microbiological criteria,
or
other factors that might require the meat to be declared unfit for human consumption or restrictions to be placed on its use,
particularly in the case of animals having undergone emergency slaughter.
In accordance with specific Community rules on specified risk material and other animal by-products, the official veterinarian is to check the removal, separation and, where appropriate, marking of such products. The official veterinarian is to ensure that the food business operator takes all necessary measures to avoid contaminating meat with specified risk material during slaughter (including stunning) and removal of specified risk material.
the monitoring and control of zoonoses and zoonotic agents;
specific laboratory testing for the diagnosis of TSEs in accordance with Regulation (EC) No 999/2001 of the European Parliament and of the Council (1) ;
the detection of unauthorised substances or products and the control of regulated substances, in particular within the framework of the National Residue Plans referred to in Council Directive 96/23/EC (2) ;
and
[F1the detection of animal diseases for which animal health rules are laid down in Union legislation.]
the health mark is applied only to animals (domestic ungulates, farmed game mammals other than lagomorphs, and large wild game) having undergone ante-mortem and post-mortem inspection in accordance with this Regulation and when there are no grounds for declaring the meat unfit for human consumption. However, the health mark may be applied before the results of any examination for trichinosis is available, if the official veterinarian is satisfied that meat from the animal concerned will be placed on the market only if the results are satisfactory;
and
health-marking takes place on the external surface of the carcase, by stamping the mark in ink or hot branding, and in such a manner that, if carcases are cut into half carcases or quarters, or half carcases are cut into three pieces, each piece bears a health mark.
the mark must indicate name of the country in which the establishment is located, which may be written out in full in capitals or shown as a two-letter code in accordance with the relevant ISO standard.
In the case of Member States, however, these codes are [F2BE, [F3BG,] CZ, DK, DE, EE, GR, ES, FR, IE, IT, CY, LV, LT, LU, HU, MT, NL, AT, PL, PT, [F3RO,] SI, SK, FI, SE and UK;]
the mark must indicate the approval number of the slaughterhouse;
and
[F4when applied in a slaughterhouse located within the Community, the mark must include the abbreviation CE, EB, EC, EF, EG, EK, EO, EY, ES, EÜ, EK or WE.
Those abbreviations must not be included in marks applied on meat imported into the Community from slaughterhouses located outside the Community.]
Textual Amendments
F2 Substituted by Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (Text with EEA relevance).
F3 Inserted by Council Regulation (EC) No 1791/2006 of 20 November 2006 adapting certain Regulations and Decisions in the fields of free movement of goods, freedom of movement of persons, company law, competition policy, agriculture (including veterinary and phytosanitary legislation), transport policy, taxation, statistics, energy, environment, cooperation in the fields of justice and home affairs, customs union, external relations, common foreign and security policy and institutions, by reason of the accession of Bulgaria and Romania.
F4 Substituted by Commission Regulation (EC) No 1021/2008 of 17 October 2008 amending Annexes I, II and III to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption and Regulation (EC) No 2076/2005 as regards live bivalve molluscs, certain fishery products and staff assisting with official controls in slaughterhouses (Text with EEA relevance).
Textual Amendments
F5 Deleted by Commission regulation (EC) No 2076/2005 of 5 December 2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (Text with EEA relevance).
If inspections reveal the presence of any disease or condition that might affect public or animal health, or compromise animal welfare, the official veterinarian is to inform the food business operator.
When the problem identified arose during primary production, the official veterinarian is to inform the veterinarian attending the holding of provenance, the food business operator responsible for the holding of provenance (provided that such information would not prejudice subsequent legal proceedings) and, where appropriate, the competent authority responsible for supervising the holding of provenance or the hunting area.
If the animals concerned were raised in another Member State or in a third country, the official veterinarian is to inform to the competent authority of the Member State where the establishment is located. That competent authority is to take appropriate measures in accordance with applicable Community legislation.
animals come from a holding or an area subject to a movement prohibition or other restriction for reasons of animal or public health;
rules on the use of veterinary medicinal products have not been complied with;
or
any other condition which might adversely affect human or animal health is present, animals may not be accepted for slaughter other than in accordance with procedures laid down under Community legislation to eliminate human or animal health risks.
If the animals are already present at the slaughterhouse, they must be killed separately and declared unfit for human consumption, taking precautions to safeguard animal and public health where appropriate. Whenever the official veterinarian considers it necessary, official controls are to be carried out on the holding of provenance.
an official auxiliary is carrying out checks on animal welfare pursuant to Sections III or IV;
and
those checks identify non-compliance with the rules on the protection of animals,
the official auxiliary is immediately to inform the official veterinarian and, if necessary in cases of urgency, is to take the necessary measures referred to in paragraphs 1 to 4 pending the arrival of the official veterinarian.
derives from animals that have not undergone ante-mortem inspection, except for hunted wild game;
derives from animals the offal of which has not undergone post-mortem inspection, unless otherwise provided for under this Regulation or Regulation (EC) No 853/2004;
derives from animals which are dead before slaughter, stillborn, unborn or slaughtered under the age of seven days;
results from the trimming of sticking points;
[F1derives from animals affected by animal diseases for which animal health rules are laid down in the Union legislation listed in Annex I to Council Directive 2002/99/EC (3) , except if it is obtained in conformity with the specific requirements provided for in that legislation, unless otherwise provided for in Section IV;]
derives from animals affected by a generalised disease, such as generalised septicaemia, pyaemia, toxaemia or viraemia;
is not in conformity with microbiological criteria laid down under Community legislation to determine whether food may be placed on the market;
exhibits parasitic infestation, unless otherwise provided for in Section IV;
contains residues or contaminants in excess of the levels laid down in Community legislation. Any overshooting of the relevant level should lead to additional analyses whenever appropriate;
without prejudice to more specific Community legislation, derives from animals or carcases containing residues of forbidden substances or from animals that have been treated with forbidden substances;
consists of the liver and kidneys of animals more than two years old from regions where implementation of plans approved in accordance with Article 5 of Directive 96/23/EC has revealed the generalised presence of heavy metals in the environment;
has been treated illegally with decontaminating substances;
has been treated illegally with ionising or UV-rays;
contains foreign bodies (except, in the case of wild game, material used to hunt the animal);
exceeds the maximum permitted radioactivity levels laid down under Community legislation;
indicates patho-physiological changes, anomalies in consistency, insufficient bleeding (except for wild game) or organoleptic anomalies, in particular a pronounced sexual odour;
derives from emaciated animals;
contains specified risk material, except as provided for under Community legislation;
shows soiling, faecal or other contamination;
consists of blood that may constitute a risk to public or animal health owing to the health status of any animal from which it derives or contamination arising during the slaughter process;
in the opinion of the official veterinarian, after examination of all the relevant information, it may constitute a risk to public or animal health or is for any other reason not suitable for human consumption.
having undergone emergency slaughter outside the slaughterhouse; or
if derived from flocks where a treatment of the meat will be applied in accordance with Part (E) of Annex II to Regulation (EC) No 2160/2003 before placing the meat on the market.]
Official auxiliaries may assist the official veterinarian with all tasks, subject to the following restrictions and to any specific rules laid down in Section IV:
in relation to auditing tasks, official auxiliaries may only collect information regarding good hygienic practices and HACCP-based procedures;
in relation to ante-mortem inspection and checks concerning the welfare of animals, official auxiliaries may only make an initial check of animals and help with purely practical tasks;
and
in relation to post-mortem inspection, the official veterinarian must regularly check the work of official auxiliaries and, in the case of animals having undergone emergency slaughter outside the slaughterhouse, carry out the inspection personally.
in slaughterhouses, throughout both ante-mortem and post-mortem inspection;
and
in game handling establishments, throughout post-mortem inspection.
the official veterinarian need not be present at the time of ante-mortem inspection in the slaughterhouse if:
an official veterinarian or an approved veterinarian carried out ante-mortem inspection at the holding of provenance, checked the food chain information and communicated the results of the check to the official auxiliary at the slaughterhouse,
the official auxiliary at the slaughterhouse is satisfied that the food chain information does not point to any possible problem for food safety and that the animal's general state of health and welfare is satisfactory,
and
the official veterinarian regularly satisfies himself/herself that the official auxiliary is carrying out such checks properly;
the official veterinarian need not be present at all times during post-mortem inspection if:
an official auxiliary carries out post-mortem inspection and puts aside meat with abnormalities and all other meat from the same animal,
the official veterinarian subsequently inspects all such meat,
and
the official auxiliary documents his/her procedures and findings in a manner that allows the official veterinarian to be satisfied that standards are being met.
However, in the case of poultry and lagomorphs, the official auxiliary may discard meat with abnormalities and, subject to Section IV, the official veterinarian need not systematically inspect all such meat.
to animals that have undergone emergency slaughter;
to animals suspected of having a disease or condition that may adversely affect human health;
to bovine animals from herds that have not been declared officially free of tuberculosis;
to bovine, ovine and caprine animals from herds that have not been declared officially free of brucellosis;
[F1in the case of an outbreak of animal diseases for which animal health rules are laid down in Union legislation. This concerns animals susceptible to the particular disease in question that come from the particular region as defined in Article 2 of Council Directive 64/432/EEC (4) ;
when stricter controls are necessary to take account of emerging diseases or particular OIE listed diseases.]
The Member States may permit slaughterhouse staff to take over the activities of the official auxiliaries in controlling the production of poultry and rabbit meat under the following conditions:
[F4Where the establishment has used good hygiene practice in accordance with Article 4(4) of this Regulation and the HACCP procedure for at least 12 months, the competent authority may authorise staff of the establishment to carry out tasks of official auxiliaries. This authorisation may only be granted if the staff of the establishment have been trained, to the satisfaction of the competent authority, in the same way as the official auxiliaries for the tasks of official auxiliaries or for the specific tasks they are authorised to perform. This staff must be placed under the supervision, direction and responsibility of the official veterinarian. In these circumstances, the official veterinarian shall be present at ante-mortem and post-mortem examinations, shall supervise these activities and carry out regular performance tests to ensure that the performance of the slaughterhouse staff meets the specific criteria laid down by the competent authority, and shall document the results of those performance tests. Where the level of hygiene of the establishment is affected by the work of this staff, where this staff does not carry out the tasks properly or where in general this staff carries out its work in a manner that the competent authority considers unsatisfactory, this staff shall be replaced by official auxiliaries.]
The competent authority of the Member State shall decide, in principle and on a case-by-case basis, whether to permit the implementation of the system described above. Where the Member State decides in principle in favour of this system, it shall inform the Commission of that decision and its associated conditions. For food business operators in a Member State implementing the system, the actual use of the system is optional. Food business operators shall not be forced by the competent authority to introduce the system described here. Where the competent authority is not convinced that the food business operator satisfies the requirements, the system shall not be implemented in that establishment. In order to assess this, the competent authority shall carry out an analysis of the production and inspection records, the type of activities undertaken in the establishment, the history of compliance with rules, the expertise, professional attitude and sense of responsibility of the slaughterhouse staff in regard to food safety, together with other relevant information.
Slaughterhouse staff who have received specific training, under the supervision of the official veterinarian, may, under the responsibility and the supervision of the official veterinarian, carry out specific sampling and testing tasks in respect of animals of all species.
national and Community legislation on veterinary public health, food safety, animal health, animal welfare and pharmaceutical substances;
principles of the common agricultural policy, market measures, export refunds and fraud detection (including the global context: WTO, SPS, Codex Alimentarius, OIE);
essentials of food processing and food technology;
principles, concepts and methods of good manufacturing practice and quality management;
pre-harvest quality management (good farming practices);
promotion and use of food hygiene, food related safety (good hygiene practices);
principles, concepts and methods of risk-analysis;
principles, concepts and methods of HACCP, use of HACCP throughout the food production food chain;
prevention and control of food-borne hazards related to human health;
population dynamics of infection and intoxication;
diagnostic epidemiology;
monitoring and surveillance systems;
auditing and regulatory assessment of food safety management systems;
principles and diagnostic applications of modern testing methods;
information and communication technology as related to veterinary public health;
data-handling and applications of biostatistics;
investigations of outbreaks of food-borne diseases in humans;
relevant aspects concerning TSEs;
animal welfare at the level of production, transport and slaughter;
environmental issues related to food production (including waste management);
precautionary principle and consumer concerns;
and
principles of training of personnel working in the production chain.
Candidates may acquire the required knowledge as part of their basic veterinary training, or through training undertaken, or professional experience acquired, after qualifying as veterinarians. The competent authority may arrange for different tests to take account of candidates' background. However, when the competent authority is satisfied that a candidate has acquired all the required knowledge as part of a university degree, or through continuing education resulting in a postgraduate qualification, it may waive the requirement for a test.
at least 500 hours of theoretical training and at least 400 hours of practical training, covering the areas specified in paragraph 5;
and
such additional training as is required to enable official auxiliaries to undertake their duties competently.
in relation to holdings:
theoretical part:
familiarity with the farming industry organisation, production methods, international trade etc.,
good livestock husbandry practices,
basic knowledge of diseases, in particular zoonoses — viruses, bacteria, parasites etc.,
monitoring for disease, use of medicines and vaccines, residue testing,
hygiene and health inspection,
animal welfare on the farm and during transport,
environmental requirements — in buildings, on farms and in general,
relevant laws, regulations and administrative provisions,
consumer concerns and quality control;
practical part:
visits to holdings of different types and using different rearing methods,
visits to production establishments,
observation of the loading and unloading of animals,
laboratory demonstrations,
veterinary checks,
documentation;
in relation to slaughterhouses and cutting plants:
theoretical part:
familiarity with the meat industry organisation, production methods, international trade and slaughter and cutting technology,
basic knowledge of hygiene and good hygienic practices, and in particular industrial hygiene, slaughter, cutting and storage hygiene, hygiene of work,
HACCP and the audit of HACCP-based procedures,
animal welfare on unloading after transport and at the slaughterhouse,
basic knowledge of the anatomy and physiology of slaughtered animals,
basic knowledge of the pathology of slaughtered animals,
basic knowledge of the pathological anatomy of slaughtered animals,
relevant knowledge concerning TSEs and other important zoonoses and zoonotic agents,
knowledge of methods and procedures for the slaughter, inspection, preparation, wrapping, packaging and transport of fresh meat,
basic knowledge of microbiology,
ante-mortem inspection,
examination for trichinosis,
post-mortem inspection,
administrative tasks,
knowledge of the relevant laws, regulations and administrative provisions,
sampling procedure,
fraud aspects;
practical part:
animal identification,
age checks,
inspection and assessment of slaughtered animals,
post-mortem inspection in a slaughterhouse,
examination for trichinosis,
identification of animal species by examination of typical parts of the animal,
identifying and commenting on parts of slaughtered animals in which changes have occurred,
hygiene control, including the audit of the good hygiene practices and the HACCP-based procedures,
recording the results of ante-mortem inspection,
sampling,
traceability of meat,
documentation.
Carcases and offal of bovine animals under six weeks old are to undergo the following post-mortem inspection procedures:
visual inspection of the head and throat; incision and examination of the retropharyngeal lymph nodes ( Lnn retropharyngiales ); inspection of the mouth and fauces; palpation of the tongue; [F6removal of the tonsils;]
visual inspection of the lungs, trachea and oesophagus; palpation of the lungs; incision and examination of the bronchial and mediastinal lymph nodes ( Lnn. bifucationes, eparteriales and mediastinales ). The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption;
visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;
visual inspection of the diaphragm;
visual inspection of the liver and the hepatic and pancreatic lymph nodes, ( Lnn portales ); palpation and, if necessary, incision of the liver and its lymph nodes;
visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes ( Lnn. gastrici, mesenterici, craniales and caudales ); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes;
visual inspection and, if necessary, palpation of the spleen;
visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes ( Lnn. renales );
visual inspection of the pleura and peritoneum;
visual inspection and palpation of the umbilical region and the joints. In the event of doubt, the umbilical region must be incised and the joints opened; the synovial fluid must be examined.
Textual Amendments
F6 Deleted by Commission Regulation (EC) No 1663/2006 of 6 November 2006 amending Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (Text with EEA relevance).
Carcases and offal of bovine animals over six weeks old are to undergo the following post-mortem inspection procedures:
visual inspection of the head and throat; incision and examination of the sub-maxillary, retropharyngeal and parotid lymph nodes ( Lnn retropharyngiales, mandibulares and parotidei ); examination of the external masseters, in which two incisions must be made parallel to the mandible, and the internal masseters (internal pterygoid muscles), which must be incised along one plane. The tongue must be freed to permit a detailed visual inspection of the mouth and the fauces and must itself be visually inspected and palpated [F7;] [F6The tonsils must be removed;]
inspection of the trachea and oesophagus; visual examination and palpation of the lungs; incision and examination of the bronchial and mediastinal lymph nodes ( Lnn. bifucationes, eparteriales and mediastinales ). The trachea and the main branches of the bronchi must be opened lengthways and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption;
visual inspection of the pericardium and heart, the latter being incised lengthways so as to open the ventricles and cut through the interventricular septum;
visual inspection of the diaphragm;
visual inspection and palpation of the liver and the hepatic and pancreatic lymph nodes, ( Lnn portales ); incision of the gastric surface of the liver and at the base of the caudate lobe to examine the bile ducts;
visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes ( Lnn. gastrici, mesenterici, craniales and caudales ); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes;
visual inspection and, if necessary, palpation of the spleen;
visual inspection of the kidneys and incision, if necessary, of the kidneys and the renal lymph nodes ( Lnn. renales );
visual inspection of the pleura and the peritoneum;
visual inspection of the genital organs (except for the penis, if already discarded);
visual inspection and, if necessary, palpation and incision of the udder and its lymph nodes ( Lnn. supramammarii ). In cows, each half of the udder must be opened by a long, deep incision as far as the lactiferous sinuses ( sinus lactiferes ) and the lymph nodes of the udder must be incised, except when the udder is excluded from human consumption.
Textual Amendments
F7 Substituted by Commission Regulation (EC) No 1663/2006 of 6 November 2006 amending Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (Text with EEA relevance).
Carcases and offal of sheep and goats are to undergo the following post-mortem inspection procedures:
visual inspection of the head after flaying and, in the event of doubt, examination of the throat, mouth, tongue and retropharyngeal and parotid lymph nodes. Without prejudice to animal-health rules, these examinations are not necessary if the competent authority is able to guarantee that the head, including the tongue and the brains, will be excluded from human consumption;
visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and the bronchial and mediastinal lymph nodes ( Lnn. bifucationes, eparteriales and mediastinales ); in the event of doubt, these organs and lymph nodes must be incised and examined;
visual inspection of the pericardium and heart; in the event of doubt, the heart must be incised and examined;
visual inspection of the diaphragm;
visual inspection of the liver and the hepatic and pancreatic lymph nodes, ( Lnn portales ); palpation of the liver and its lymph nodes; incision of the gastric surface of the liver to examine the bile ducts;
visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes ( Lnn. gastrici, mesenterici, craniales and caudales );
visual inspection and, if necessary, palpation of the spleen;
visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes ( Lnn. renales );
visual inspection of the pleura and peritoneum;
visual inspection of the genital organs (except for the penis, if already discarded);
visual inspection of the udder and its lymph nodes;
visual inspection and palpation of the umbilical region and joints of young animals. In the event of doubt, the umbilical region must be incised and the joints opened; the synovial fluid must be examined.
Carcases and offal of solipeds are to undergo the following post-mortem inspection procedures:
visual inspection of the head and, after freeing the tongue, the throat; palpation and, if necessary, incision of the sub-maxillary, retropharyngeal and parotid lymph nodes ( Lnn retropharyngiales, mandibulares and parotidei ). The tongue must be freed to permit a detailed visual inspection of the mouth and the fauces and must itself be visually examined and palpated [F7;] [F6The tonsils must be removed;]
visual inspection of the lungs, trachea and oesophagus; palpation of the lungs; palpation and, if necessary, incision of the bronchial and mediastinal lymph nodes ( Lnn. bifucationes, eparteriales and mediastinales ). The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; however, these incisions are not necessary where the lungs are excluded from human consumption;
visual inspection of the pericardium and the heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;
visual inspection of the diaphragm;
visual inspection, palpation and, if necessary, incision of the liver and the hepatic and pancreatic lymph nodes, ( Lnn portales );
visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes ( Lnn. gastrici, mesenterici, craniales and caudales ); incision, if necessary, of the gastric and mesenteric lymph nodes;
visual inspection and, if necessary, palpation of the spleen;
visual inspection and palpation of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes ( Lnn. renales );
visual inspection of the pleura and peritoneum;
visual inspection of the genital organs of stallions (except for the penis, if already discarded) and mares;
visual inspection of the udder and its lymph nodes ( Lnn. supramammarii ) and, if necessary, incision of the supramammary lymph nodes;
visual inspection and palpation of the umbilical region and joints of young animals. In the event of doubt, the umbilical region must be incised and the joints opened; the synovial fluid must be examined;
all grey or white horses must be inspected for melanosis and melanomata by examination of the muscles and lymph nodes ( Lnn. subrhomboidei ) of the shoulders beneath the scapular cartilage after loosening the attachment of one shoulder. The kidneys must be exposed and examined by incision through the entire kidney.
the health certificate provided for in Chapter X, Part A, accompanies them;
and
the requirements of paragraphs 2 to 5 are complied with.
checks on records or documentation at the holding, including food chain information;
the examination of the pigs to determine whether:
they have a disease or condition which may be transmitted to animals or humans through handling or eating the meat, or are behaving, individually or collectively, in a manner indicating that such a disease may occur,
they show disturbance of general behaviour or signs of disease which may make the meat unfit for human consumption,
or
there is evidence or reasons to suspect that they may contain chemical residues in excess of the levels laid down in Community legislation, or residues of forbidden substances.
a control of the animals' identification;
and
a screening to ascertain whether animal welfare rules have been complied with and whether signs of any condition which might adversely affect human or animal health are present. An official auxiliary may carry out this screening.
if the pigs have not left the holding of provenance for the slaughterhouse, they are to be re-examined and a new health certificate issued;
if the pigs are already en route for or at the slaughterhouse, slaughter may be authorised once the reason for the delay has been assessed, provided that the pigs undergo a further veterinary ante-mortem inspection.
visual inspection of the head and throat; incision and examination of the submaxillary lymph nodes ( Lnn mandibulares ); visual inspection of the mouth, fauces and tongue;
visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and the bronchial and mediastinal lymph nodes ( Lnn. bifucationes, eparteriales and mediastinales ). The trachea and the main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human consumption;
visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and cut through the interventricular septum;
visual inspection of the diaphragm;
visual inspection of the liver and the hepatic and pancreatic lymph nodes, ( Lnn portales ); palpation of the liver and its lymph nodes;
visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes ( Lnn. gastrici, mesenterici, craniales and caudales ); palpation and, if necessary, incision of the gastric and mesenteric lymph nodes;
visual inspection and, if necessary, palpation of the spleen;
visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes ( Lnn. renales );
visual inspection of the pleura and peritoneum;
visual inspection of the genital organs (except for the penis, if already discarded);
visual inspection of the udder and its lymph nodes ( Lnn. supramammarii ); incision of the supramammary lymph nodes in sows;
visual inspection and palpation of the umbilical region and joints of young animals; in the event of doubt, the umbilical region must be incised and the joints opened.
the health certificate provided for in Chapter X, Part A, accompanies them;
and
the requirements of paragraphs 2 to 5 are complied with.
checks on records or documentation at the holding, including food chain information;
a flock inspection, to determine whether the birds:
have a disease or condition which may be transmitted to animals or humans through handling or eating the meat, or are behaving in a manner indicating that such a disease may occur,
show disturbance of general behaviour or signs of disease which may make the meat unfit for human consumption,
or
show evidence that they may contain chemical residues in excess of the levels laid down in Community legislation, or residues of forbidden substances.
a control of the animals' identification;
and
a screening to ascertain whether animal welfare rules have been complied with and whether signs of any condition which might adversely affect human or animal health are present. An official auxiliary may carry out this screening.
if the flock has not left the holding of provenance for the slaughterhouse, it is to be re-examined and a new health certificate issued;
if the flock is already en route for or at the slaughterhouse, slaughter may be authorised once the reason for the delay has been assessed, provided that the flock is re-examined.
daily inspection of the viscera and body cavities of a representative sample of birds;
a detailed inspection of a random sample, from each batch of birds having the same origin, of parts of birds or entire birds declared unfit for human consumption following post-mortem inspection;
and
any further investigations necessary when there is reason to suspect that the meat from the birds concerned could be unfit for human consumption.
The requirements for poultry are to apply to farmed lagomorphs.
a control of the animals' identification;
and
a screening to ascertain whether animal welfare rules have been complied with and whether signs of any condition which might adversely affect human or animal health are present.
Textual Amendments
Textual Amendments
a visual examination of the carcase, its cavities and, where appropriate, organs with a view to:
detecting any abnormalities not resulting from the hunting process. For this purpose, the diagnosis may be based on any information that the trained person has provided concerning the behaviour of the animal before killing,
checking that death was not caused by reasons other than hunting.
If an assessment cannot be made on the basis of visual examination alone, a more extensive inspection must be carried out in a laboratory;
an investigation of organoleptic abnormalities;
palpation of organs, where appropriate;
where there are serious grounds for suspecting the presence of residues or contaminants, an analysis by sampling of residues not resulting from the hunting process, including environmental contaminants. When a more extensive inspection is made on the basis of such suspicions, the veterinarian must wait until that inspection has been concluded before assessing all the game killed during a specific hunt, or those parts suspected of showing the same abnormalities;
examination for characteristics indicating that the meat presents a health risk, including:
abnormal behaviour or disturbance of the general condition of the live animal, as reported by the hunter,
the generalised presence of tumours or abscesses affecting different internal organs or muscles,
arthritis, orchitis, pathological changes in the liver or the spleen, inflammation of the intestines or the umbilical region,
the presence of foreign bodies not resulting from the hunting process in the body cavities, stomach or intestines or in the urine, where the pleura or peritoneum are discoloured (when relevant viscera are present),
the presence of parasites,
formation of a significant amount of gas in the gastro-intestinal tract with discolouring of the internal organs (when these viscera are present),
significant abnormalities of colour, consistency or odour of muscle tissue or organs,
aged open fractures,
emaciation and/or general or localised oedema,
recent pleural or peritoneal adhesions,
and
other obvious extensive changes, such as putrefaction.
In addition to the cases provided for in Section II, Chapter V, meat presenting during post-mortem inspection any of the characteristics listed in paragraph 3(e) of Part A is to be declared unfit for human consumption.
Official controls carried out in relation to TSEs are to take account of the requirements of Regulation (EC) No 999/2001 and other relevant Community legislation.
This Annex applies to live bivalve molluscs and, by analogy, to live echinoderms, live tunicates and live marine gastropods.
The reference method for this analysis is the five-tube, three dilutions Most Probable Number (MPN) test specified in ISO 16649-3. Alternative methods may be used if they are validated against this reference method in accordance with the criteria in EN/ISO 16140.]
make an inventory of the sources of pollution of human or animal origin likely to be a source of contamination for the production area;
examine the quantities of organic pollutants which are released during the different periods of the year, according to the seasonal variations of both human and animal populations in the catchment area, rainfall readings, waste-water treatment, etc.;
determine the characteristics of the circulation of pollutants by virtue of current patterns, bathymetry and the tidal cycle in the production area;
and
establish a sampling programme of bivalve molluscs in the production area which is based on the examination of established data, and with a number of samples, a geographical distribution of the sampling points and a sampling frequency which must ensure that the results of the analysis are as representative as possible for the area considered.
that there is no malpractice with regard to the origin, provenance and destination of live bivalve molluscs;
the microbiological quality of live bivalve molluscs in relation to the production and relaying areas;
for the presence of toxin-producing plankton in production and relaying waters and biotoxins in live bivalve molluscs;
and
for the presence of chemical contaminants in live bivalve molluscs.
the likely variation in faecal contamination,
and
the parameters referred to in paragraph 6 of Part A.
periodic sampling to detect changes in the composition of plankton containing toxins and their geographical distribution. Results suggesting an accumulation of toxins in mollusc flesh must be followed by intensive sampling;
periodic toxicity tests using those molluscs from the affected area most susceptible to contamination.
The competent authority must:
establish and keep up to date a list of approved production and relaying areas, with details of their location and boundaries, as well as the class in which the area is classified, from which live bivalve molluscs may be taken in accordance with the requirements of this Annex. This list must be communicated to interested parties affected by this Annex, such as producers, gatherers and operators of purification centres and dispatch centres;
immediately inform the interested parties affected by this Annex, such as producers, gatherers and operators of purification centres and dispatch centres, about any change of the location, boundaries or class of a production area, or its closure, be it temporary or final;
and
act promptly where the controls prescribed in this Annex indicate that a production area must be closed or reclassified or can be re-opened.
To decide on the classification, opening or closure of production areas, the competent authority may take into account the results of controls that food business operators or organisations representing food business operators have carried out. In that event, the competent authority must have designated the laboratory carrying out the analysis and, if necessary, sampling and analysis must have taken place in accordance with a protocol that the competent authority and the food business operators or organisation concerned have agreed.
Official controls on pectinidae and live marine gastropods, which are not filter feeders, harvested outside classified production areas are to be carried out in fish auctions, dispatch centres and processing establishments.
Such official controls are to verify compliance with the health standards for live bivalve molluscs laid down in Annex III, Section VII, Chapter V, to Regulation (EC) No 853/2004 as well as compliance with other requirements of Annex III, Section VII, Chapter IX to that Regulation.]
Textual Amendments
F10 Substituted by Commission Regulation (EU) No 505/2010 of 14 June 2010 amending Annex II to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of officials controls on products of animal origin intended for human consumption (Text with EEA relevance).
a regular check on the hygiene conditions of landing and first sale;
inspections at regular intervals of vessels and establishments on land, including fish auctions and wholesale markets, to check, in particular:
where appropriate, whether the conditions for approval are still fulfilled,
whether the fishery products are handled correctly,
for compliance with hygiene and temperature requirements,
and
the cleanliness of establishments, including vessels, and their facilities and equipment, and staff hygiene;
and
checks on storage and transport conditions.
may be carried out when vessels call at a port in a Member State;
concern all vessels landing fishery products at ports in the Community, irrespective of flag;
and
may, if necessary, when the competent authority of the Member State the flag of which the vessel is flying carries out the official control, be carried out while the vessel is at sea or when it is in a port in another Member State or in a third country.
In the case of an inspection of a factory or freezer vessel flying the flag of a Member State carried out with a view to the approval of the vessel, the competent authority of the Member State the flag of which the vessel is flying is to carry out inspections in such a manner as to comply with the requirements of Article 3, particularly the time limits of Article 3(2). If necessary, that competent authority may inspect the vessel while it is at sea or when it is in a port in another Member State or in a third country.
When the competent authority of the Member State the flag of which the vessel is flying has granted the vessel conditional approval in accordance with Article 3, that competent authority may authorise a competent authority of:
another Member State,
or
a third country that appears on a list of third countries from which imports of fishery products are permitted drawn up in accordance with Article 11, to carry out a follow-up inspection with a view to granting full approval or prolonging conditional approval in accordance with Article 3(1)(b) or to keeping approval under review in accordance with Article 3(4). If necessary, that competent authority may inspect the vessel while it is at sea or when it is in a port in another Member State or in a third country.
Official controls of fishery products are to include at least the following elements.
Random organoleptic checks must be carried out at all stages of production, processing and distribution. One aim of these checks is to verify compliance with the freshness criteria established in accordance with Community legislation. In particular, this includes verifying, at all stages of production, processing and distribution, that fishery products at least exceed the baselines of freshness criteria established in accordance with Community legislation.
When the organoleptic examination reveals any doubt as to the freshness of the fishery products, samples may be taken and subjected to laboratory tests to determine the levels of total volatile basic nitrogen (TVB-N) and trimethylamine nitrogen (TMA-N).
The competent authority is to use the criteria laid down under Community legislation.
When the organoleptic examination gives cause to suspect the presence of other conditions which may affect human health, appropriate samples are to be taken for verification purposes.
Random testing for histamine is to be carried out to verify compliance with the permitted levels laid down under Community legislation.
Monitoring arrangements are to be set up to control the levels of residues and contaminants in accordance with Community legislation.
Where necessary, microbiological checks are to be performed in accordance with the relevant rules and criteria laid down under Community legislation.
Random testing is to take place to verify compliance with Community legislation on parasites.
Checks are to take place to ensure that:
fishery products derived from poisonous fish of the following families are not placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae ;
fresh, prepared, frozen and processed fishery products belonging to the family Gempylidae , in particular Ruvettus pretiosus and Lepidocybium flavobrunneum , may only be placed on the market in wrapped/packaged form and must be appropriately labelled to provide information to the consumer on preparation/cooking methods and on the risk related to the presence of substances with adverse gastrointestinal effects. The scientific names of the fishery products and the common names must appear on the label;
fishery products containing biotoxins such as ciguatera or other toxins dangerous to human health are not placed on the market. However, fishery products derived from bivalve molluscs, echinoderms, tunicates and marine gastropods may be placed on the market if they have been produced in accordance with Section VII of Annex III to Regulation (EC) No 853/2004 and comply with the standards laid down in Chapter V, point 2, of that Section.]
Fishery products are to be declared unfit for human consumption if:
organoleptic, chemical, physical or microbiological checks or checks for parasites have shown that they are not in compliance with the relevant Community legislation;
they contain in their edible parts contaminants or residues in excess of the limits laid down in Community legislation or at levels where the calculated dietary intake would exceed the acceptable daily or weekly intake for humans;
they derive from:
poisonous fish,
fishery products not complying with the requirement of part G, point 2, of Chapter II concerning biotoxins,
or
bivalve molluscs, echinoderms, tunicates or marine gastropods containing marine biotoxins in total quantities exceeding the limits referred to in Regulation (EC) No 853/2004;
or
the competent authority considers that they may constitute a risk to public or animal health or are for any other reason not suitable for human consumption.
These controls may take place at the occasion of veterinary checks carried out pursuant to Community provisions on animal or public health or animal welfare and may be carried out by an approved veterinarian.
The following third-country establishments need not appear on lists drawn up and updated in accordance with Article 12(4):
establishments handling products of animal origin for which Annex III to Regulation (EC) No 853/2004 does not lay down requirements;
establishments carrying out only primary production;
establishments carrying out only transport operations;
establishments carrying out only the storage of products of animal origin not requiring temperature-controlled storage conditions.
The representative of the competent authority of the third country of dispatch issuing a certificate to accompany a consignment of products of animal origin destined for the Community must sign the certificate and ensure that it bears an official stamp. This requirement applies to each sheet of the certificate if it consists of more than one. In the case of factory vessels, the competent authority may authorise the captain or another ship's officer to sign the certificate.
[F7Certificates must be drawn up at least in the official language or languages of the Member State of destination and those of the Member State in which the border inspection takes place, or be accompanied by a certified translation into that language or languages. However, a Member State may consent to the use of an official Community language other than its own.]
The original version of the certificate must accompany consignments on entry into the Community.
Certificates must consist of:
a single sheet of paper;
or
two or more pages that are part of an integrated and indivisible sheet of paper;
or
a sequence of pages numbered so as to indicate that it is a particular page in a finite sequence (for example, ‘ page 2 of four pages ’ ).
Certificates must bear a unique identifying number. Where the certificate consists of a sequence of pages, each page must indicate this number.
The certificate must be issued before the consignment to which it relates leaves the control of the competent authority of the third country of dispatch.]
[X1 OJ L 147, 31.5.2001, p. 1 . Regulation as last amended by Commission Regulation (EC) No 2245/2003 ( OJ L 333, 20.12.2003, p. 28 ).
OJ L 125, 23.5.1996, p. 10 . Directive as amended by Regulation (EC) No 806/2003 ( OJ L 122, 16.5.2003, p. 1 ).
OJ L 77, 16.3.2001, p. 1 . Regulation as last amended by Regulation (EC) No 655/2004 ( OJ L 104, 8.4.2004, p. 48 ).]
Editorial Information
X1 Substituted by Corrigendum to 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 (Official Journal of the European Union L 139 of 30 April 2004).
Textual Amendments
F1 Substituted by Commission Implementing Regulation (EU) No 739/2011 of 27 July 2011 amending Annex I to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of officials controls on products of animal origin intended for human consumption (Text with EEA relevance).
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