Proposal for a Regulation of the European Parliament and of the Council laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption
Date: 2000-07-14
Institutions: European Commission
Subjects: animal product, consumer protection, food inspection, foodstuff, health legislation

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Proposal for a Regulation of the European Parliament and of the Council laying down detailed
rules for the organisation of official controls on products of animal origin intended for human
consumption

(2000/C 365 E/04)

(Text with EEA relevance)

COM(2000) 438 final (cid:16) 2000/0180(COD)

(Submitted by the Commission on 14 July 2000)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(5) Official controls should be carried out with the aim of
analysing and identifying potential risks to the health of
those handling or consuming products of animal origin.

Having regard to the Treaty establishing the European
Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of
Committee,

the Economic and Social

Having regard to the opinion of the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty,

Whereas:

(1) Community legislation lays down the general rules for

performing official controls of foodstuffs.

(2) In addition to the general rules, detailed rules must be laid
down for official controls on products of animal origin in
order to take account of specific animal and public health
hazards that may be associated with such products.

in particular

(3) Such detailed rules for official controls on products of
animal origin must include all aspects which may affect
the safety of such products with regard to animal and
public health,
requirements during the
primary production and subsequent handling, manu-
facture, processing, storage and transport of animals and
products, ante-mortem inspections of slaughter animals,
animal welfare, post-mortem inspections of slaughtered
animals, compliance with hygiene conditions in estab-
to be applied to products of
lishments,
animal origin in order to eliminate animal health risks
and other measures to protect animal and public health.

the treatment

(4) Official controls must cover those aspects which are most
important for protecting animal and public health and be
based on the most
information available on
problems which might constitute a hazard to human
health.

recent

(6) The detailed rules for the organisation of official controls
must be based on a proper risk analysis and on the
opinion of the Scientific Committee. For that purpose, it
is necessary to proceed to a risk assessment of the current
ante- and post-mortem inspection procedures. Awaiting
the results thereof,
inspection procedures
the present
must remain in place.

(7) It must be ensured that

the animal welfare rules are
in particular with regard to humane

complied with,
slaughter of animals.

(8) Council Directive 89/662/EEC of 11 December 1989
concerning veterinary checks in intra-Community trade
with a view to the completion of the internal market (1),
as last amended by the Act of Accession of Austria,
Finland and Sweden, provides that,
in order to ensure
the free movement of goods within the Community,
official checks on products of animal origin must be
carried out at the place of dispatch and that spot checks
in the Member State of destination can be carried out at
In the event of a serious
the place of destination.
presumption of
irregularity, however, checks can be
carried out while the goods are in transit.

(9) Community legislation on food safety must have a sound
scientific basis. To that end, the scientific committees in
the field of consumer protection and food safety set up by
Commission Decision 97/579/EC (2) must be consulted
wherever necessary.

(10) Since the measures necessary for the implementation of
this Regulation are measures of general scope within the
meaning of Article 2 of Council Decision 1999/468/EC of
28 June 1999 laying down the procedures for the exercise
of implementing powers conferred on the Commission (3),
they should be adopted by use of
regulatory
procedure provided for in Article 5 of that Decision,

the

(1) OJ L 395, 30.12.1989, p. 13.
(2) OJ L 237, 28.8.1997, p. 18.
(3) OJ L 184, 17.7.1999, p. 23.

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HAVE ADOPTED THIS REGULATION:

Article 4

Article 1

This Regulation lays down the detailed rules for the organi-
sation of official controls with regard to animal health and
public health on products of animal origin intended for
human consumption.

Article 2

For the purposes of this Regulation, the definitions laid down
in

? Council Directive 89/662/EEC concerning veterinary checks
in intra-Community trade with a view to the completion of
the internal market,

In accordance with the procedure referred to in Article 5 and
where necessary after having obtained the opinion of
the
appropriate Scientific Committee, the Commission shall:

(a) amend or supplement the Annexes to this Regulation in
order to take account of scientific and technical progress,
in particular with regard to the ante- and post-mortem
inspection procedures for meat;

(b) adopt any implementing rules needed to ensure uniform

implementation of this Regulation.

Article 5

The Commission shall be assisted by the Standing
by Council Decision

instituted

1.
Veterinary Committee,
68/361/EEC (1).

? Council Regulation . . ./. . . laying down the animal health
rules governing the production, placing on the market and
importation of products of animal origin intended for
human consumption,

2. Where reference is made to this paragraph, the Regu-
latory procedure
laid down in Article 5 of Decision
1999/468/EC shall apply, in compliance with Article 7(3) and
Article 8 thereof.

? European Parliament and Council Regulation . . ./. . . on the

hygiene of foodstuffs,

The period provided for in Article 5(6) of Decision

3.
1999/468/EC shall be 3 months.

shall apply as appropriate.

Article 6

Article 3

In addition to more general requirements on the official control
of
foodstuffs laid down in Community legislation, Member
States shall ensure that products of animal origin are subject
to official controls under this Regulation.

This Regulation shall enter into force on the date of its publi-
cation in the Official Journal of the European Communities.

It shall apply from 1 January 2004

This Regulation shall be binding in its entirety and directly
applicable in all Member States.

(1) OJ L 225, 18.10.1968, p. 23.

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ANNEX I

CONTROL REQUIREMENTS APPLICABLE TO ALL PRODUCTS

1. Official controls shall be carried out on products of animal origin at all stages from primary production up to and

including the marketing and in particular:

(a) Controls on farms shall aim to verify compliance with hygiene rules and animal health rules. These controls shall
be combined with controls concerning animal welfare, residues and feedstuffs required under Community legis-
lation.

Where hygiene, animal welfare or residue rules are not complied with, or diseases communicable to humans and
animals are diagnosed, appropriate action shall be taken.

In the case of slaughter animals, the official service responsible for carrying out ante- and post-mortem inspection
at the slaughterhouse shall be informed about any problem occurring at the farm that may have an impact on
food safety.

(b) Controls on establishments, to verify or examine compliance with the specific hygiene rules laid down in

Regulation . . . (laying down specific hygiene rules for food of animal origin) and in particular:

? where appropriate, compliance with the approval conditions,

? the correct use of the health marks or registration numbers,

? the health status of the products,

? compliance with temperature requirements and, where applicable, microbiological requirements.

(c) Without prejudice to the requirements of Council Directive 89/662/EEC, controls during the marketing of

products, to verify or examine in particular:

? compliance with the rules on health marking,

? compliance with maintaining of the cold chain,

? where appropriate, the documents accompanying the consignment.

(d) Any other control necessary to verify compliance with Community legislation.

2. During official controls,

(a) the operators of establishments, the owner or his representative, as well as persons responsible for the products
during marketing must facilitate the controls, ensure suitable conditions and make available any space and
facilities needed to ensure a proper control;

(b) the competent authority shall be given free access to establishments and any other infrastructures such as farms,

vessels, means of transport, auction halls, etc.

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ANNEX II

MEAT INSPECTION

CHAPTER I

REQUIREMENTS APPLICABLE TO ALL MEAT

The official controls shall include ante-mortem and post-mortem inspections of food animals. Ante- and post-mortem
inspections shall be carried out in accordance with the procedures described in this Annex pending an opinion of the
appropriate Scientific Committee on their review.

I. Responsibilities and frequency of controls

1. Official controls shall be carried out under the supervision and responsibility of the official veterinarian. He may be

assisted by auxiliaries placed under his authority and responsibility for carrying out the following activities:

(a) where ante-mortem inspection on the holding is foreseen, collecting information needed by the official veter-

inarian to assess the health status of the herd or flock of origin and to make a diagnosis;

(b) ante-mortem inspection in the slaughterhouse, provided that the official veterinarian is actually able to supervise
the work of the auxiliaries directly on the spot. In this case the auxiliary’s role is to make an initial check on the
animals and to help with purely practical tasks;

(c) post-mortem inspection, provided that the official veterinarian is actually able to supervise the work of the

auxiliaries directly on the spot;

(d) health control of cut and stored meat;

(e) inspection and supervision of approved establishments, means of transport, etc.

2. In order to provide the assistance referred to above, the auxiliaries shall form part of an inspection team under the
authority and responsibility of the official veterinarian and must be independent of the establishment being inspected.
The competent authority of the Member State concerned shall determine the composition of the inspection team for
each establishment in such a way that the official veterinarian is able to supervise the above operations.

3. The frequency of official controls shall be determined on the basis of an assessment of the health risks. Care shall be

taken in particular to ensure that:

(a) in slaughterhouses, at least one official veterinarian is present throughout both the ante-mortem and post-
mortem inspection. Member States may request a derogation from this requirement
to accommodate the
needs of small and medium-sized slaughterhouses. For that purpose, they shall submit to the Commission a
fully documented dossier to justify their request. This dossier shall contain information on the qualifications of
the inspectors replacing the official veterinarian, the type of slaughterhouses where they will operate and the
conditions under which they will perform inspections. The Commission shall examine the dossier and where
appropriate approve the request in accordance with the procedure laid down in Article 5. This approval may
include the conditions under which this derogation may be applied;

(b) in cutting plants, a member of the inspection team is present at least once a day when meat is being worked on;

(c) in approved cold stores and re-packaging centres, a member of the inspection team is regularly present.

4. Detailed rules governing the assistance referred to above shall be adopted if necessary,

in accordance with the

procedure referred to in Article 5.

II. Ante-mortem health inspection

1. Before slaughter, animals must undergo an ante-mortem inspection. Sufficient lighting must be available.

2. Where provided for in this Regulation, the ante-mortem inspection shall be carried out at the holding of provenance

of the animals.

3. The inspection must determine, in particular, whether:

(a) the animals are properly identified and do come from a holding or an area subject to a movement prohibition for

reasons of animal health, unless permitted under Community law;

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(b) the animals are suffering from a disease transmissible to humans or animals, show symptoms of such a disease or

are in a general condition indicating that such a disease may occur;

(c) the animals show symptoms of a disease or a disorder affecting their general condition which may make their

meat unfit for human consumption;

(d) animal welfare rules have been complied with;

(e) animals presented for slaughter are clean; if they are not clean, the official veterinarian shall give appropriate
instructions to ensure that the animals are made clean or to prevent otherwise the meat being contaminated
during the slaughter operations;

(f)

the animals come from a holding or area subject to an animal or public health restriction;

(g) other conditions which might adversely affect human or animal health are present;

(h) rules on the use of veterinary medicinal products have been complied with.

4. Animals

? suffering from a notifiable animal disease or a disease transmissible to animals or humans,

? showing signs that they have had substances administered to them or have consumed substances which may

make their meat harmful to human health,

may not be slaughtered for human consumption. Such animals must be killed separately and their meat hygienically
disposed of.

5. The slaughter of animals suspected of suffering from a disease or showing signs of conditions which may adversely
affect human or animal health, must be deferred. These animals must undergo, where necessary, detailed examination
in order to make a diagnosis. Where post-mortem inspection is necessary in order to make a diagnosis the
the animals are to be slaughtered separately or after the normal slaughtering
veterinarian may decide that
process. Those animals must undergo a post-mortem inspection supplemented,
if necessary, by sampling and
laboratory examinations.

6. The slaughter of animals under a specific scheme for the eradication or control of a specific disease such as
brucellosis or tuberculosis or other zoonotic agents such as salmonellosis must be carried out under the conditions
imposed by and the direct supervision of the official veterinarian.

III. Post-mortem health inspection

1. Slaughtered animals must be submitted without delay to a post-mortem health inspection in accordance with

scientific rules. This inspection shall include, in particular:

(a) a visual inspection of the slaughtered animal and its organs with a view to detecting visible contamination or

other defects;

(b) palpation and, where judged necessary by the official veterinarian, incision of those parts of the animal which

have undergone any change or are suspect for any other reason;

(c) organoleptic examination;

(d) where necessary, laboratory tests, in particular to reveal the presence of agents of zoonotic diseases;

(e) any measure deemed necessary to check compliance with Community rules on the use of veterinary medicinal

products and other chemical substances used during farming and on residues.

2. Where necessary in order to make a diagnosis or further investigations, the official veterinarian may request that the

slaughter process be slowed down or halted.

3. Where the ante-mortem or post-mortem inspection reveals a condition likely to affect human or animal health the
official veterinarian may ask for the requisite laboratory tests to be carried out if he considers them necessary to
substantiate his diagnosis or to detect substances with pharmacological action likely to be present given the
pathological condition observed.

Where any doubt remains, further cuts and inspections must be made until a definitive diagnosis can be reached.

4. Lymphnodes requiring incision must be systematically subjected to multiple incisions and a visual inspection.

5. During the inspection precautions must be taken to ensure that meat is not contaminated by actions such as

palpation, cutting or incision.

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IV. Emergency slaughter

The meat of animals that have undergone emergency slaughter must, in addition to the normal post-mortem inspection,
undergo sampling for further examination or any other examination considered necessary.

V. Decision following health inspections

Following ante-mortem and post-mortem inspection, the following shall be declared unfit for human consumption:

(a) meat from

? animals affected by one of the diseases subject to animal-health restrictions, unless procedures have been

introduced under the Community rules to eliminate any animal-health risk,

? cachectic animals,

? animals slaughtered too young;

(b) meat found to exhibit:

? cachexia,

? generalised infectious disease,

? septicaemia, pyaemia, toxaemia or viraemia,

? the presence of residues of prohibited substances or residues in excess of permitted Community levels,

? malignant or multiple tumours,

? multiple abscesses,

? serious injuries in different areas of the carcase or in different viscera,

? insufficient bleeding,

? extensive blood or serum infiltration,

? widespread subcutaneous or muscular parasitic infestation,

? ecchymosis,

? where appropriate, organoleptic anomalies,

? anomalies in consistency, particularly oedema or severe emaciation,

? widespread lesions, soiling or contamination;

(c) parts of a slaughtered animal which show localised lesions, contamination or inflammation not affecting the health

of the rest of the meat;

(d) the blood of an animal whose meat has been declared unfit for human consumption in accordance with the

preceding points, and blood contaminated by stomach contents or any other substance;

(e) carcases the offal of which has not undergone post-mortem inspection, unless otherwise provided for under this

Regulation;

(f)

the carcases of animals suffering from any other condition which may constitute a public health danger according to
the professional opinion of the official veterinarian.

The official veterinarian can give instruction that the meat can only be used for a particular purpose such as processing.

VI. Communication of inspection results

The official veterinarian shall record the results of the ante- and post-mortem inspections. If inspection reveals the
presence of a disease or condition which might affect public or animal health, or of residues, this information shall be
communicated to the competent authority responsible for supervising the holding of provenance of the animals, and to
the person responsible for the animals concerned. Following such communication, immediate action must be taken to
remedy the situation.

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VII. Professional qualifications of auxiliaries

1. Only persons who have passed a test organised by the competent authority of the Member States may be appointed

as auxiliaries.

2. Only candidates who prove that they have:

(a) followed at least 400 hours of theoretical training, including laboratory demonstrations, and

(b) received at least 200 hours of practical training

shall be eligible for the above test. The practical training shall take place in slaughterhouses, cutting plants, cold
stores and at inspection posts for meat or, in the case of ante-mortem inspection, on a holding.

3. The tests for auxiliaries shall consist of a theoretical part and a practical part and shall cover the following subjects:

(a) for the inspection of holdings:

(i) theoretical part:

? familiarity with the farming industry D organisation, economic significance, production methods, inter-

national trade, etc.,

? anatomy and pathology,

? basic knowledge of diseases D viruses, bacteria, parasites, etc.,

? monitoring for disease, use of medicines and vaccines, residue testing,

? hygiene and health inspection,

? animal welfare on the farm, during transport and at the slaughterhouse,

? environmental requirements D in buildings, on farms and in general,

? national and international rules,

? consumer concerns and quality control;

(ii) practical part:

? visits to farms of different types and using different rearing methods,

? visits to production establishments,

? loading and unloading of means of transport,

? visits to laboratories,

? veterinary checks,

? documentation,

? practical experience;

(b) for inspection at slaughterhouses:

(i) theoretical part:

? 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,

? basic knowledge of hygiene, and in particular industrial hygiene, slaughter, cutting and storage hygiene,

hygiene of work and the control of the HACCP system,

? knowledge of methods and procedures for the slaughter, inspection, preparation, wrapping, packaging

and transport of fresh meat,

? knowledge of the laws, regulations and administrative provisions relating to their work,

? sampling procedures;

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(ii) practical part:

? identification of animals,

? inspection and assessment of slaughtered animals,

? identification of animal species by examination of typical parts of the animal,

? identification of a number of parts of slaughtered animals in which changes have occurred, and

comments thereon,

? post-mortem inspection in a slaughterhouse,

? hygiene control, including the control of the HACCP system,

? sampling,

? identification of meat.

VIII. Other responsibilities during inspections

Owners or persons responsible for the animals must cooperate with the officials carrying out ante- and post-mortem
inspections. They must provide access to the animals, meat and relevant documentation, in a condition suitable for
inspection. They must provide additional assistance at the request of the official veterinarian or auxiliary. Where they fail
to cooperate as requested, the inspection shall be suspended until they consent to do so to the extent required for the
inspection.

CHAPTER II

MEAT OF DOMESTIC UNGULATES

In addition to the common requirements, the following requirements shall apply:

I. Ante-mortem health inspection

Where the ante-mortem inspection is carried out at the slaughterhouse, the animals must undergo such inspection
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

II. Post-mortem health inspection

1. Post-mortem inspections shall include, where necessary:

? incision of certain organs and lymph nodes and, depending on the conclusions reached during the inspection,

the uterus,

? a visual

inspection or palpation. Where such inspection indicates that the animal has lesions which could
contaminate the carcases, equipment, staff or premises, such organs may not be incised in the slaughter-room
or any other part of the establishment where meat could be contaminated.

2. Inspections must proceed as follows:

A. Bovine animals over six weeks old

(a) 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;

(b) inspection of the trachea; visual examination and palpation of the lungs and oesophagus;

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;

(c) visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles

and cut through the interventricular septum;

(d) visual inspection of the diaphragm;

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(e) 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;

(f) 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;

(g) visual inspection and, if necessary, palpation of the spleen;

(h) visual inspection of the kidneys and incision, if necessary, of the kidneys and the renal lymph nodes (Lnn.

renales);

(i) visual inspection of the pleura and the peritoneum;

(j) visual inspection of the genital organs;

(k) visual inspection and, if necessary, palpation and incision of the udder and its lymph nodes (Lnn. supram-
ammarii). 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.

B. Bovine animals under six weeks old

(a) 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; removal of the tonsils;

(b) 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;

(c) visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles

and cut through the interventricular septum;

(d) visual inspection of the diaphragm;

(e) 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;

(f) 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;

(g) visual inspection and, if necessary, palpation of the spleen;

(h) visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

(i) visual inspection of the pleura and peritoneum;

(j) 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.

C. Swine

(a) 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;

(b) visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and the bronchial and medi-
astinal 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;

(c) visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles

and cut through the interventricular septum;

(d) visual inspection of the diaphragm;

(e) visual inspection of the liver and the hepatic and pancreatic lymph nodes, (Lnn. portales); palpation of the liver

and its lymph nodes;

(f) 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;

(g) visual inspection and, if necessary, palpation of the spleen;

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(h) visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

(i) visual inspection of the pleura and peritoneum;

(j) visual inspection of the genital organs;

(k) visual inspection of the udder and its lymph nodes (Lnn. supramammarii); incision of the supramammary

lymph nodes in sows;

(l) 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.

D. Sheep and goats

(a) visual inspection of the head after flaying and, in the event of doubt, examination of the throat, mouth,
these
including

tongue and retropharyngeal and parotid lymph nodes. Without prejudice to animal-health rules,
examinations are not necessary if the competent authority is able to guarantee that the head,
the tongue and the brains, will be excluded from human consumption;

(b) visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and the bronchial and medi-
astinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales); in the event of doubt, these organs and
lymph nodes must be incised and examined;

(c) visual

inspection of the pericardium and heart;

in the event of doubt, the heart must be incised and

examined;

(d) visual inspection of the diaphragm;

(e) 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;

(f) visual inspection of the gastro-intestinal tract, the mesentery and the gastric and mesenteric lymph nodes

(Lnn. gastrici, mesenterici, craniales and caudales);

(g) visual inspection and, if necessary, palpation of the spleen;

(h) visual inspection of the kidneys; incision, if necessary, of the kidneys and the renal lymph nodes (Lnn. renales);

(i) visual inspection of the pleura and peritoneum;

(j) visual inspection of the udder and its lymph nodes;

(k) 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.

E. Domestic solipeds

(a) 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. The tonsils must be removed;

(b) 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;

(c) 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;

(d) visual inspection of the diaphragm;

(e) visual inspection, palpation and, if necessary, incision of the liver and the hepatic and pancreatic lymph

nodes, (Lnn. portales);

(f) 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;

(g) visual inspection and, if necessary, palpation of the spleen;

(h) visual inspection and palpation of the kidneys; incision, if necessary, of the kidneys and the renal lymph

nodes (Lnn. renales);

(i) visual inspection of the pleura and peritoneum;

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(j) visual inspection of the genital organs of stallions and mares;

(k) visual inspection of the udder and its lymph nodes (Lnn. supramammarii) and, if necessary, incision of the

supramammary lymph nodes;

(l) 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;

(m) 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.

III. Special controls

A. Trichinosis

Meat from porcine animals (domestic, farmed game and wild game) and solipeds shall either be submitted to an
examination to detect the possible presence of trichinae (Trichinella spp) or undergo a cold treatment.

B. Cysticercosis in swine and cattle

Examination for Cysticercus bovis and Cysticercus cellulosae shall include an examination of the parts of the animal likely
to be infested.

After removal of parts unfit for human consumption, meat from animals with non-generalised infestation must
undergo a cold treatment.

C. Glanders in solipeds

Examination for glanders in solipeds shall include a careful examination of mucous membranes from the trachea,
larynx, nasal cavities and sinuses and their ramifications, after splitting the head in the median plane and excising
the nasal septum.

The following shall be established in accordance with the Standing Veterinary Committee procedure, and after the
Scientific Committee has given its opinion:

(a) the methods to be applied when examining for the conditions referred to in this heading;

(b) the cold treatment to be applied to meat in the case of trichinosis and cysticercosis;

(c) the conditions under which derogations can be granted to the regions of the Community shown by epidemi-

ological studies to be free of trichinosis or glanders.

IV. Decision to declare meat unfit

for human consumption following ante-mortem and post-mortem

inspection

1. In addition to the cases provided for in Chapter I(V), the following shall be declared unfit for human consumption:

(a) meat from animals:

(i) in which one of the following conditions has been diagnosed:

? generalised actinobacillosis or actinomycosis,

? blackleg and anthrax,

? generalised tuberculosis,

? generalised lymphadenitis,

? glanders,

? rabies,

? tetanus,

? acute salmonellosis,

? acute brucellosis,

? swine erysipelas,

? botulism;

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(ii) showing acute lesions of broncho-pneumonia, pleurisy, peritonitis, metritis, mastitis, arthritis, pericarditis,
enteritis or meningo-encephalomyelitis confirmed by a detailed inspection, possibly supplemented by a
bacteriological examination and an investigation for residues of substances with a pharmacological effect.
However, when the results of these special examinations are favourable, the carcases shall be declared fit for
human consumption after the parts unfit for human consumption have been removed;

(iii) affected by the following parasitic diseases: generalised sarcocystosis, generalised cysticerosis, trichinosis;

(iv) which are dead, stillborn or unborn;

(v) which have been slaughtered too young, and the meat of which is oedematous;

(vi) showing clinical signs of emaciation or advanced anaemia;

(vii) which have produced a positive or inconclusive reaction to tuberculin and in which the post-mortem
inspection has revealed localised tuberculous lesions located in a number of organs or areas of
the
carcase. However, when a tuberculous lesion has been found in the lymph nodes of the same organ or
part of the carcase, only the affected organ or part of the carcase and the associated lymph nodes shall be
declared unfit for human consumption;

(viii) which have reacted positively or inconclusively to brucellosis confirmed by lesions indicating acute
infection. Even where no such lesion has been found, the udder, genital tract and blood must nevertheless
be declared unfit for human consumption;

(b) parts of carcases showing signs of major serous or haemorrhagic infiltrations, localised abscesses or localised

contamination;

(c) offal and viscera with pathological lesions of infectious, parasitic or traumatic origin;

(d) where a carcase or offal is affected with caseous lymphadenitis or any other suppurative condition but that

condition is not generalised or associated with emaciation:

(i) any organ and its associated lymph node, if the condition concerned exists on the surface or in the substance

of that organ or lymph node;

(ii) in any cases where (i) does not apply, the lesion and such of the surrounding parts as appropriate having
regard to the age and degree of activity of the lesion, on the understanding that an old, firmly encapsulated
lesion may be regarded as inactive;

(e) meat resulting from trimming of the sticking point;

(f)

the liver and kidneys of animals more than two years old from regions where plans implemented under Article 5
of Directive 96/23/EC have revealed the generalised presence of heavy metals in the environment;

(g) meat which gives off a pronounced sexual odour.

2. The following must bear a special mark and be processed:

(i) meat from male pigs used for breeding;

(ii) meat from uncastrated male pigs, cryptorchid and hermaphrodite pigs with a carcase weight of more than 80 kg,
except where the establishment is able to guarantee that carcases giving off a pronounced boar taint may be
detected, using a method recognised in accordance with the Standing Veterinary Committee procedure or, in the
absence of such a method, one recognised by the competent authority concerned.

V. Special conditions for low capacity slaughterhouses

(a) Slaughterhouse situated in regions suffering from special geographical constraits or affected by supply difficulties and
slaughterhouses supplying meat locally must notify the veterinary service of the time of slaughter and the number
and provenance of the animals, so that the ante-mortem inspection can be carried out either on the farm or
immediately prior to slaughter at the slaughterhouse;

(b) The official veterinarian or an auxiliary must carry out the post-mortem inspection of the meat. Where the meat has
lesions or appears to have deteriorated, the post-mortem inspection must be carried out by the official veterinarian.
The official veterinarian or the auxiliary under his responsibility must regularly verify compliance with the hygiene
rules laid down in this Regulation.

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CHAPTER III

POULTRYMEAT

In addition to the common requirements, the following requirements shall apply:

I. Ante-mortem inspection

1. Slaughter of a flock of poultry from a holding may be authorised only when:

(a) either the birds intended for slaughter have been submitted to an ante-mortem inspection at the holding and are

accompanied by the health certificate provided for in point V,

(b) or, 24 to 72 hours before the arrival of the birds at the slaughterhouse, the official veterinarian is in possession of

a document to be established by the competent authority containing:

? relevant up-to-date information regarding the flock of provenance,

in particular details taken from the

holding’s records covering the type of poultry slaughtered,

? proof that the holding of origin is under the supervision of a veterinarian responsible for the health at the

farm.

This information must be assessed before deciding what measures are to be taken with respect to birds coming from
the holding concerned, particularly the type of ante-mortem inspection required.

Where the conditions laid down in (a) or (b) above are not met, it may be decided:

? either to postpone slaughter until the holding of origin has been inspected with a view to obtaining the required

information,

? or to authorise slaughter after carrying out the tests provided for in (2)(b) below.

Any costs incurred as a result of the application of this paragraph shall be charged to the farmer in accordance with
rules to be adopted by the competent authority.

However, in the case of farmers with an annual production of not more than 20 000 domestic fowl, 15 000 ducks,
10 000 turkeys, 10 000 geese, or an equivalent number of another species of poultry, the ante-mortem inspection
may be carried out at the slaughterhouse. In that case, the farmer must provide a statement to the effect that his
annual production does not exceed the said numbers.

2. The ante-mortem inspection on the farm of provenance shall comprise:

(a) checking the farmer’s records or documentation;

(b) additional examination to determine whether the birds:

(i) are suffering from a disease transmissible to humans or animals or are behaving, individually or collectively,

in a manner indicating that such a disease may occur,

(ii) show disturbance of general behaviour or signs of disease which may make the meat unfit for human

consumption;

(c) regular sampling of water and feed to check compliance with withdrawal periods;

(d) tests for zoonotic agents.

3. Where there is doubt as to the identity of a consignment of poultry and the birds are to undergo ante-mortem health
inspection at the slaughterhouse, the official veterinarian must examine each crate where the birds show symptoms
as referred to in point 2(b) of this Chapter.

4. Where the birds are not slaughtered within three days of the issue of the health certificate provided for in point 1(a):

? where the birds have not left the holding of origin, a new health certificate must be issued,

? where the birds are already at the slaughterhouse, slaughter may be authorised once the reason for the delay has

been assessed, provided a new health certificate is issued, or the birds are re-examined.

5. In the case of clinically healthy poultry from a flock which must be slaughtered under a programme for the control
of infectious disease or a zoonotic disease, the birds must be slaughtered at the end of the day or under conditions
such that other poultry are not contaminated.

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If the animals of such a flock show clinical symptoms of the following diseases:

(a) ornithosis,

(b) salmonellosis,

their slaughter for human consumption shall be prohibited.

Slaughter is authorised at the end of the normal slaughter process provided precautions are taken to keep to a
minimum the risk of spreading bacteria and to clean and disinfect the facilities after slaughter. The meat of such birds
must be handled in the same way as meat declared unfit for human consumption.

6. In slaughterhouses situated in regions suffering from special geographical constraints or affected by supply

difficulties, or in those serving the local market, the following rules must be complied with.

(a) Slaughterhouses must notify the veterinary service of the time of slaughter and the number and origin of the

birds.

(b) The official veterinarian or an auxiliary must be present at the time of slaughter. Where this is not possible the
meat may not leave the establishment until the post-mortem inspection has been carried out. The official
veterinarian or the auxiliary under his responsibility must regularly monitor compliance with the hygiene rules.

(c) The competent authority must monitor the distribution chain of meat from the establishment and ensure that

products declared unfit for consumption are appropriately marked, used and disposed of.

II. Post-mortem inspection

1. As part of the post-mortem inspection, the official veterinarian must:

(a) inspect the viscera and body cavities of a representative number of birds from each batch of birds from the same

origin;

(b) subject to a detailed inspection a random sample of birds the meat of which was declared unfit for human

consumption following the post-mortem health inspection;

(c) carry out any further investigations deemed necessary where there is reason to suspect that the meat from the

birds concerned could be unfit for human consumption.

2. In the case of partly-eviscerated birds the intestines of which are removed immediately (effilØ), the viscera and the
body cavities of a representative number of birds from each batch shall be inspected after evisceration. Where such
inspection reveals anomalies in a number of birds, all the birds in the consignment shall be inspected in accordance
with point 1.

3. In the case of deferred evisceration:

(a) the post-mortem health inspection referred to in point 1 shall take place at the latest fifteen days after slaughter,

during which period the poultry must be stored at a temperature below 4 FC;

(b) not later than the end of this period, evisceration must take place at an establishment approved for that purpose.

In such cases, the carcases must be accompanied by the health certificate under point VI;

(c) the poultry meat must not bear the health mark before the evisceration referred to in point (b) has been

performed.

III. Decision to declare meat unfit for human consumption following the post-mortem inspection

In addition to the cases provided for in Chapter I(V), poultrymeat must be declared unfit for human consumption where
the post-mortem inspection reveals any of the following:

? systematic mycosis and local lesions in organs suspected of having been caused by pathogenic agents transmissible

to humans or their toxins,

? cachexia,

? extensive mechanical lesions, including those due to extensive scalding,

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? ascites,

? extensive subcutaneous or muscular parasitic infestation and systematic parasitism.

IV. Technical assistance

The competent authority may permit the members of staff of the undertaking to carry out technical operations related
to inspection under the direct supervision of the official veterinarian provided they have received special training from
the official veterinarian. The general criteria for such training shall be laid down in accordance with the procedure
referred to in Article 5.

V. Specimen health certificate

HEALTH CERTIFICATE (1)

for poultry transported from the holding to the slaughterhouse

Competent service:

..............................................................................

No (2) ..............................................................................

I. Identification of birds

Species:

....................................................................................................................................................................................................

Number of birds: ...................................................................................................................................................................................

II. Provenance of birds

Address of holding of origin: ............................................................................................................................................................

Identification of poultry house: .........................................................................................................................................................

III. Destination of birds

The birds will be transported to the following slaughterhouse: ...............................................................................................

....................................................................................................................................................................................................................

by the following means of transport: ..............................................................................................................................................

IV. Declaration

I, the undersigned declare that the birds described above were examined before slaughter at the above-mentioned
holding at (time) ............... on (date) ............... and were found to be healthy.

Done at ....................................................., on .....................................................

(Place)

(Date)

Stamp

(1) This certificate is valid for 72 hours.
(2) Optional.

........................................................................................................
(Signature of veterinarian)

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VI. Specimen health certificate

for poultry intended for the production of foie gras, stunned, bled and plucked at the fattening holding and
transported to a cutting plant equipped with a separate room for evisceration

HEALTH CERTIFICATE

Competent service:

..............................................................................

No (1) ..............................................................................

I.

Identification of uneviscerated carcases

Species: .....................................................................................................................................................................................................

Number: ...................................................................................................................................................................................................

II. Provenance of uneviscerated carcases

Address of fattening holding: .............................................................................................................................................................

III. Destination of uneviscerated carcases

The uneviscerated carcases will be transported to the following cutting plant: ...................................................................

....................................................................................................................................................................................................................

IV. Declaration

I, the undersigned declare that the uneviscerated carcases described above are of birds which were examined before
slaughter on the above-mentioned fattening holding at (time) .............. on ............... (date) and found to be healthy.

Done at ....................................................., on .....................................................

(Place)

(Date)

........................................................................................................
(Signature of veterinarian)

Stamp

(1) Optional.

CHAPTER IV

MEAT FROM FARMED LAGOMORPHS

As a general rule, the requirements applicable to poultrymeat shall apply mutatis mutandis. However, where the ante-
mortem inspection is not carried out at the holding of origin, the animals must undergo such inspection within 24
hours of arrival at the slaughterhouse. Where more than 24 hours elapse between the ante-mortem inspection and
slaughter, the animals must be re-inspected immediately before slaughter.

CHAPTER V

FARMED GAME MEAT

In addition to the common requirements, the following requirements shall apply:

I. Ante-mortem health inspections

1. Ante-mortem inspection must be carried out either at the slaughterhouse or at the holding of provenance before
slaughter at the holding or transportation to the slaughterhouse. In the latter case, the ante-mortem inspection at the
slaughterhouse may be restricted to detecting injuries sustained during transport. In addition, the identification of the
animals must be checked.

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Live animals inspected at the holding must be accompanied by a certificate drawn up in accordance with the
specimen in point III stating that the animals were inspected at the holding and found healthy.

2. Where the ante-mortem inspection is not carried out at the holding of provenance, the animals must undergo such
inspection within 24 hours of arrival at the slaughterhouse. The animals must be re-inspected immediately before
slaughter where more than 24 hours elapse between the ante-mortem inspection and slaughter.

Each animal or batch of animals sent for slaughter must be identified to enable the competent authority to determine
its provenance.

II. Post-mortem health inspection

Meat from species susceptible to trichinosis must be examined for the presence of trichinae.

III. Specimen health certificate

HEALTH CERTIFICATE

for live farmed game transported from the holding to the slaughterhouse

Competent service:

.............................................................................

No (1):

.............................................................................

I.

Identification

Species of animal: ..................................................................................................................................................................................

Number of animals: ..............................................................................................................................................................................

Identification marking:

.........................................................................................................................................................................

II. Provenance of animals

Address of holding of origin: .............................................................................................................................................................

III. Destination of animals

These animals are being transported to the following slaughterhouse: ..................................................................................

....................................................................................................................................................................................................................

by the following means of transport: ..............................................................................................................................................

IV. Declaration

I, the undersigned hereby declare that the animals described above underwent an ante-mortem inspection at the
above holding on ............... (date) at ............... (time) and were found to be healthy.

Done at ....................................................., on .....................................................

(Place)

(Date)

Stamp

(1) Optional.

........................................................................................................
(Signature of veterinarian)

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CHAPTER VI

WILD GAME MEAT

In addition to the common requirements, the following requirements shall apply:

I. Post-mortem health inspection

1. Wild game must be inspected as soon as possible after admission to the game processing house.

2. During post-mortem inspection, the official veterinarian must carry out:

(a) a visual examination of the carcase, its cavities and where appropriate organs with a view to:

? detecting any abnormalities. For this purpose, the diagnosis may be based on any information provided by

the hunter 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;

(b) an investigation of organoleptic abnormalities;

(c) palpation of organs, where necessary;

(d) an analysis of residues including environmental contaminants by sampling, where there are serious grounds for
suspecting the presence of residues or contaminants. Where 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 which are suspected of showing the same abnormalities;

(e) examination for characteristics indicating that the meat presents a health risk, including:

(i) abnormal behaviour or disturbance of the general condition of the live animal, as reported by the hunter;

(ii) the generalised presence of tumours or abscesses affecting different internal organs or muscles;

(iii) arthritis, orchitis, changes in the liver or the spleen, inflammation of the intestines or the umbilical region;

(iv) the presence of foreign bodies in the body cavities, stomach or intestines or in the urine, where the pleura

or peritoneum are discoloured;

(v) formation of a significant amount of gas in the gastro-intestinal tract with discolouring of the internal

organs;

(vi) significant abnormalities of colour, consistency or odour of muscle tissue or organs;

(vii) aged open fractures;

(viii) emaciation and/or general or localised oedema;

(ix) recent pleural or peritoneal adhesions;

(x) other obvious extensive changes, such as putrefaction.

3. Where the official veterinarian so requires, the spinal column and the head must be split lengthwise.

4. In the case of small wild game not eviscerated immediately after killing, the official veterinarian must carry out a
post-mortem inspection on a representative sample of animals from the same source. Where inspection reveals a
disease transmissible to man or defects as referred to in point 2, the veterinarian must carry out more checks on the
entire batch to determine whether it must be declared unfit for human consumption or whether each carcase must
be inspected individually.

5. In the event of doubt, the official veterinarian may perform any further cuts and inspections of the relevant parts of

the animals necessary to reach a final diagnosis.

6. In the case of wild boar or other species susceptible to trichinosis, several samples of meat from each animal must be
analysed. Samples must be taken at least from the jaw and diaphragmatic muscles, the muscles of the lower front leg,
the intercostal muscles and the tongue muscles. The samples must be analysed using methods approved in
accordance with the procedure referred to in Article 5 and on the basis of an opinion from the Scientific Veterinary
Committee.

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II. Decision to declare meat unfit for human consumption following inspection

In addition to the cases provided for in Chapter I(V), the following wild game meat shall be declared unfit for human
consumption:

? meat presenting lesions, except for recent lesions due to killing, and localised malformations or abnormalities, in so

far as these render the meat unfit for human consumption or dangerous to human health,

? meat presenting characteristics as listed in point I(2)(e) of this Chapter during post-mortem inspection,

? meat in which trichinosis is detected,

? meat showing anomalies which may render it unfit for human consumption.

ANNEX III

LIVE BIVALVE MOLLUSCS

1. The competent authority must fix the location and the boundaries of production areas for bivalve molluscs. The areas
from which harvesting of bivalve molluscs is authorised must be classified by the competent authority in three
categories according to the level of the faecal contamination as follows:

(a) Class A areas: areas from which live bivalve molluscs may be collected for direct human consumption. Live bivalve

molluscs taken from these areas must meet the requirements of point IV of this Section.

(b) Class B areas: areas from which live bivalve molluscs may be collected, but only placed on the market for human

consumption after treatment in a purification centre or after relaying.

(c) Class C areas: areas from which live bivalve molluscs may be collected but placed on the market only after

relaying over a long period (at least two months).

2. In order to determine the faecal contamination level of an area, the competent authority must:

? make an inventory of the sources of pollution from human or animal origin likely to be a source of contami-

nation 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,

? 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.

3. The public-health control arrangements must include the periodic monitoring of live bivalve molluscs relaying and

production areas in order to:

(a) prevent any malpractice with regard to the origin, provenance and destination of live bivalve molluscs;

(b) check the microbiological quality of

live bivalve molluscs in relation to the production and relaying areas;

(c) check for the presence of toxin-producing plankton in production and relaying waters and biotoxins in live

bivalve molluscs;

(d) check for the presence of chemical contaminants, maximum permitted levels of which shall be fixed in

accordance with the procedure referred to in Article 5.

For the purposes of (b), (c) and (d) above, sampling plans must be drawn up for carrying out such checks at regular
intervals or on a case-by-case basis where harvesting periods are irregular.

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4. Sampling plans for production and relaying areas must take particular account of:

(a) likely variations in faecal contamination;

(b) possible variations in the presence of plankton containing marine biotoxins. Sampling must be carried out as

follows:

(i) monitoring plankton: periodic sampling to detect changes in the composition of the plankton containing
toxins and the geographical distribution thereof. Results suggesting an accumulation of toxins in mollusc flesh
must be followed by intensive sampling, by increasing the number of sampling points and number of samples
taken in growing and fishing waters, and

(ii) periodic toxicity tests using those molluscs from the affected area most susceptible to contamination.

Molluscs from the area concerned may not be placed on the market until further sampling has yielded satisfactory
toxicity test results;

(c) possible contamination of the molluscs.

If sampling shows that placing live bivalve molluscs on the market may constitute a hazard to human health, the
competent authority must close the production area from which the contaminated molluscs originated until the
situation has been remedied.

5. The competent authority shall monitor production areas where the harvesting of bivalve molluscs is forbidden or
subject to special conditions, to ensure that products harmful to human health are not placed on the market.

6. A control system must be set up comprising laboratory tests to verify compliance with the requirements for the end
product, in particular to verify that the levels of marine biotoxins and contaminants do not exceed safety limits and
that the microbiological quality of the molluscs does not constitute a hazard to human health.

7. The competent authority must:

(a) 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 Section.

This list must be communicated to interested parties affected by this Section, such as producers, gatherers and
operators of purification centres and dispatch centres;

(b) immediately inform the interested parties affected by the present Section, and in particular the producers,
gatherers and operators of purification centres and dispatch centres, about any change of the location, boundaries
or class of the production area, or its closure, be it temporary or final.

ANNEX IV

FISHERY PRODUCTS

In addition to the common control requirements, the following shall apply:

1. Official controls on fishery products shall be carried out at the time of landing or before first sale at an auction or

wholesale market.

2. Official controls shall include:

(a) Organoleptic surveillance testing.

Random checks must be carried out to check compliance with the freshness criteria laid down in Community
legislation. Where there is doubt as to the freshness of the products, the organoleptic examination must be
repeated.

(b) Chemical analysis.

Where 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 TVB-N (Total Volatile Basic Nitrogen).

The TVB-N levels shall be specified for each category of species in accordance with the procedure referred to in
Article 5.

Where the organoleptic examination gives cause to suspect the presence of other conditions which may affect
human health, samples may be taken for verification purposes.

(c) Surveillance testing for histamine to verify compliance with the permitted levels laid down in Community

legislation.

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(d) Surveillance testing for contaminants.

Monitoring arrangements shall be set up to control the levels in fishery products of contaminants such as heavy
metals and organochlorinated substances present in the aquatic environment.

(e) Microbiological checks, where necessary.

(f) Surveillance testing to verify compliance with Community legislation on endo-parasites.

Where necessary, the following shall be established in accordance with the procedure referred to in Article 5,
after an opinion has been given by the Scientific Committee:

? freshness criteria for the organoleptic evaluation of fishery products, in particular where such criteria have

not been established under existing Community legislation,

? the analytical limits, methods of analysis and sampling plans to be used for performing the official checks

referred to above.

3. The following shall be declared unfit for human consumption:

(a) fishery products which the organoleptic, chemical, physical or microbiological checks show they are not fit for

human consumption;

(b) fish or parts of fish which have not been properly examined to detect endo-parasites in accordance with

Community legislation;

(c) fishery products which contain in their edible parts contaminants present in the aquatic environment, such as
heavy metals and organochlorinated substances, at levels where the calculated dietary intake would exceed the
acceptable daily or weekly intake for humans;

(d) poisonous fish and fishery products containing biotoxins;

(e) fishery products or parts thereof considered dangerous to human health.

ANNEX V

MILK AND MILK PRODUCTS

In addition to the common control requirements, the following shall apply:

Inspection of holdings

Raw milk must come from holdings which are checked by the competent authorities of the Member State to verify
compliance with the animal and public health conditions for milk production. The frequency of such checks must be
proportionate to the risk. These inspections may be combined with checks carried out under other Community
provisions.