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 (OJ L 139, 30.4.2004)
Date: 2004-06-25
Institutions: Council of the European Union, European Parliament
Subjects: animal product, food inspection, food safety, health control, human nutrition, import (EU)

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Official Journal of the European Union

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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)

Regulation (EC) No 854/2004 should read as follows:

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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

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

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and
Social Committee (2),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251
of the Treaty (3),

Whereas:

(1)

(2)

(3)

Regulation (EC) No 852/2004 of the European Parliament
and of the Council (4) lays down general hygiene rules
applying
and Regulation (EC)
No 853/2004 of the European Parliament and of the Coun-
cil (5) lays down specific hygiene rules for products of ani-
mal origin.

foodstuffs

all

to

Specific rules for official controls on products of animal
origin are necessary to take account of specific aspects
associated with such products.

The scope of the specific control rules should mirror the
scope of the specific hygiene rules for food business opera-
tors laid down in Regulation (EC) No 853/2004. However,
Member States should also carry out appropriate official
controls to enforce national rules established in accordance

(1) OJ C 262 E, 29.10.2002, p. 449.
(2) OJ C 95, 23.4.2003, p. 22.
(3) Opinion of the European Parliament of 5 June 2003 (not yet published
in the Official Journal), Council Common Position of 27 October 2003
(OJ C 48 E, 24.2.2004, p. 82), Position of the European Parliament of
30 March 2004 (not yet published in the Official Journal) and Council
Decision of 16 April 2004.
(4) Page 3 of this Official Journal.
(5) Page 22 of this Official Journal.

(4)

(5)

(6)

(7)

(8)

with Article 1(4) of that Regulation. They may do so by
extending the principles of this Regulation to such national
rules.

Official controls on products of animal origin should cover
all aspects that are important for protecting public health
and, where appropriate, animal health and animal welfare.
They should be based on the most recent relevant infor-
mation available and it should therefore be possible to
adapt them as relevant new information becomes available.

Community legislation on food safety should have a sound
scientific basis. To that end, the European Food Safety
Authority should be consulted whenever necessary.

The nature and intensity of the official controls should be
based on an assessment of public health risks, animal
health and welfare, where appropriate, the type and
throughput of the processes carried out and the food busi-
ness operator concerned.

It is appropriate to provide for the adaptation of certain
specific control rules, through the transparent procedure
provided for in Regulation (EC) No 852/2004 and Regu-
lation (EC) No 853/2004, to provide flexibility in order to
accommodate the specific needs of establishments which
use traditional methods, have a low throughput or are
located in regions that are subject to special geographical
constraints. The procedure should also allow pilot projects
to take place in order to try out new approaches to hygiene
controls on meat. However, such flexibility should not
compromise food hygiene objectives.

Official controls on the production of meat are necessary
to verify that food business operators comply with hygiene
rules and respect criteria and targets laid down in Commu-
nity legislation. These official controls should comprise
audits of food business operators ‘activities and inspec-
tions, including checks on food business operators’ own
controls.

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(9)

In view of their specific expertise, it is appropriate for offi-
cial veterinarians to carry out audits and inspections of
slaughterhouses, game handling establishments and certain
cutting plants. Member States should have discretion to
decide which are the most appropriate staff for audits and
inspections of other types of establishments.

the Council of 28 January 2002 laying down the general prin-
ciples and requirements of food law, establishing the European
Food Safety Authority, and laying down procedures in matters of
food safety (2), and any civil or criminal liability arising from the
breach of their obligations.

(10) Official controls on the production of live bivalve molluscs
and on fishery products are necessary to check for compli-
ance with the criteria and targets laid down in Community
legislation. Official controls on the production of live
bivalve molluscs should in particular target relaying and
production areas for bivalve molluscs and the end product.

(11) Official controls on the production of raw milk are neces-
sary to check for compliance with criteria and targets laid
down in Community legislation. Such official controls
should in particular target milk production holdings and
raw milk upon collection.

(12) The requirements of this Regulation should not apply until
all parts of the new legislation on food hygiene have
entered into force. It is also appropriate to provide for at
least 18 months to elapse between entry into force and the
application of the new rules, to allow competent authori-
ties and the industries affected time to adapt.

(13) The measures necessary for the implementation of this
Regulation should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
procedures for the exercise of implementing powers con-
ferred on the Commission (1),

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

This Regulation lays down specific rules for the organisa-

1.
tion of official controls on products of animal origin.

It shall apply only in respect of activities and persons to

2.
which Regulation (EC) No 853/2004 applies.

The performance of official controls pursuant to this Regu-
3.
lation shall be without prejudice to food business operators’ pri-
mary legal responsibility for ensuring food safety, as laid down in
Regulation (EC) No 178/2002 of the European Parliament and of

Article 2

Definitions

For the purposes of this Regulation, the following defini-

1.
tions shall apply:

(a)

(b)

(c)

(d)

(e)

(f)

(g)

(h)

‘official control’ means any form of control that the compe-
tent authority performs for the verification of compliance
with food law, including animal health and animal welfare
rules;

‘verification’ means checking, by examination and the provi-
sion of objective evidence, whether specified requirements
have been fulfilled;

‘competent authority’ means the central authority of a Mem-
ber State competent to carry out veterinary checks or any
authority to which it has delegated that competence;

‘audit’ means a systematic and independent examination to
determine whether activities and related results comply with
planned arrangements and whether these arrangements are
implemented effectively and are
to achieve
objectives;

suitable

‘inspection’ means the examination of establishments, of ani-
mals and food, and the processing thereof, of food busi-
nesses, and their management and production systems,
including documents, finished product testing and feeding
practices, and of the origin and destination of production
inputs and outputs, in order to verify compliance with the
legal requirements in all cases;

‘official veterinarian’ means a veterinarian qualified, in accor-
dance with this Regulation, to act in such a capacity and
appointed by the competent authority;

‘approved veterinarian’ means a veterinarian designated by
the competent authority to carry out specific official controls
on holdings on its behalf;

‘official auxiliary’ means a person qualified, in accordance
with this Regulation, to act in such a capacity, appointed by
the competent authority and working under the authority
and responsibility of an official veterinarian;

and

(1) OJ L 184, 17.7.1999, p. 23.

(2) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation

(EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

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(i)

‘health mark’ means a mark indicating that, when it was
applied, official controls had been carried out in accordance
with this Regulation.

The definitions laid down in the following Regulations shall

2.
also apply as appropriate:

In the case of factory and freezer vessels flying the flag of
2.
Member States, the maximum periods of three and six months
applying to the conditional approval of other establishments may
be extended, if necessary. However, conditional approval shall not
exceed a total of 12 months. Inspections of such vessels shall take
place as specified in Annex III.

(a) Regulation (EC) No 178/2002;

(b)

the definitions of ‘animal by-products’, ‘TSEs’ (transmissible
spongiform encephalopathies) and ‘specified risk material’
laid down in Regulation (EC) No 1774/2002 of the Euro-
pean Parliament and of the Council of 3 October 2002 lay-
ing down health rules concerning animal by-products not
intended for human consumption (1);

(c) Regulation (EC) No 852/2004, except for the definition of

‘competent authority’;

and

(d) Regulation (EC) No 853/2004.

CHAPTER II

OFFICIAL CONTROLS IN RELATION TO COMMUNITY
ESTABLISHMENTS

3.
The competent authority shall give each approved establish-
ment, including those with conditional approval, an approval
number, to which codes may be added to indicate the types of
products of animal origin manufactured. For wholesale markets,
secondary numbers indicating units or groups of units selling or
manufacturing products of animal origin may be added to the
approval number.

4.

(a) The competent authority shall keep the approval of
establishments under review when carrying out official
controls in accordance with Articles 4 to 8.

(b)

If the competent authority identifies serious deficiencies
or has to stop production at an establishment repeat-
edly and the food business operator is not able to pro-
vide adequate guarantees regarding future production,
the competent authority shall initiate procedures to
withdraw the establishment’s approval. However, the
competent authority may suspend an establishment’s
approval if the food business operator can guarantee
that it will resolve deficiencies within a reasonable time.

(c)

In the case of wholesale markets, the competent author-
ity may withdraw or suspend approval in respect of cer-
tain units or groups of units.

Article 3

Approval of establishments

5.

Paragraphs 1, 2 and 3 shall apply both:

1.

(a) When Community legislation requires the approval of
establishments, the competent authority shall make an
on-site visit. It shall approve an establishment for the
activities concerned only if the food business operator
has demonstrated that it meets the relevant require-
ments of Regulations (EC) No 852/2004 and (EC)
No 853/2004 and other relevant requirements of food
law.

(b) The competent authority may grant conditional
approval if it appears from the on-site visit that the
establishment meets all the infrastructure and equip-
ment requirements. It shall grant full approval only if it
appears from a new on-site visit carried out within three
months of the granting of conditional approval that the
establishment meets the other requirements referred to
in (a). If clear progress has been made but the establish-
ment still does not meet all of these requirements, the
competent authority may prolong conditional approval.
However, conditional approval shall not exceed a total
of six months.

(1) OJ L 273, 10.10.2002, p. 1. Regulation as last amended by
Commission Regulation (EC) No 813/2003 (OJ L 117, 13.5.2003,
p. 22).

(a)

to establishments that begin placing products of animal ori-
gin on the market on or after the date of application of this
Regulation;

and

(b)

to establishments already placing products of animal origin
on the market but in respect of which there was previously
no requirement for approval. In the latter case, the compe-
tent authority’s on-site visit required under paragraph 1 shall
take place as soon as possible.

Paragraph 4 shall also apply to approved establishments that
placed products of animal origin on the market in accordance
with Community legislation immediately prior to the application
of this Regulation.

6. Member States shall maintain up-to-date lists of approved
establishments, with their respective approval numbers and other
relevant information, and make them available to other Member
States and to the public in a manner that may be specified in
accordance with the procedure referred to in Article 19(2).

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Article 4

General principles for official controls in respect of all
products of animal origin falling within the scope of this
Regulation

1. Member States shall ensure that food business operators
offer all assistance needed to ensure that official controls carried
out by the competent authority can be performed effectively

They shall in particular:

— give access to all buildings, premises, installations or other

infrastructures;

— make available any documentation and record required under
the present regulation or considered necessary by the com-
petent authority for judging the situation.

2.
The competent authority shall carry out official controls to
verify food business operators’ compliance with the requirements
of:

(i)

controls on food entering and leaving the establishment and
any accompanying documentation.

Audits of HACCP-based procedures shall verify that food
5.
business operators apply such procedures continuously and prop-
erly, having particular regard to ensuring that the procedures pro-
vide the guarantees specified in Section II of Annex II to Regula-
in particular, determine
tion (EC) No 853/2004. They shall,
to the extent possible,
whether the procedures guarantee,
that products of animal origin:

(a)

comply with microbiological criteria laid down under Com-
munity legislation;

(b) comply with Community legislation on residues, contami-

nants and prohibited substances;

(a) Regulation (EC) No 852/2004;

and

(b) Regulation (EC) No 853/2004;

and

(c) Regulation (EC) No 1774/2002.

3.

The official controls referred to in paragraph 1 shall include:

(a) audits of good hygiene practices and hazard analysis and

critical control point (HACCP)-based procedures;

(b)

the official controls specified in Articles 5 to 8;

and

(c) any particular auditing tasks specified in the Annexes.

4.
Audits of good hygiene practices shall verify that food busi-
ness operators apply procedures continuously and properly con-
cerning at least:

(a)

checks on food-chain information;

(b)

the design and maintenance of premises and equipment;

(c) do not contain physical hazards, such as foreign bodies.

When,
in accordance with Article 5 of Regulation (EC)
No 852/2004, a food business operator uses procedures set out
in guides to the application of HACCP principles rather than
establishing its own specific procedures, the audit shall cover the
correct use of these guides.

6.
Verification of compliance with the requirements of Regu-
lation (EC) No 853/2004 concerning the application of identifi-
cation marks shall take place in all establishments approved in
accordance with that Regulation, in addition to verification of
compliance with other traceability requirements.

In the case of slaughterhouses, game handling establish-
7.
ments and cutting plants placing fresh meat on the market,
an official veterinarian shall carry out the auditing tasks referred
to in paragraphs 3 and 4.

(c) pre-operational, operational and post-operational hygiene;

8. When carrying out auditing tasks, the competent authority
shall take special care:

(d) personal hygiene;

(e)

training in hygiene and in work procedures;

(f) pest control;

(g) water quality;

(h)

temperature control;

and

(a)

to determine whether staff and staff activities in the establish-
ment at all stages of the production process comply with the
relevant requirements of the Regulations referred to in para-
graph 1(a) and (b). To support the audit, the competent
authority may carry out performance tests, in order to ascer-
tain that staff performance meets specified parameters;

(b)

to verify the food business operator’s relevant records;

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(c)

to take samples for laboratory analysis whenever necessary;

and

(d)

to document elements taken into account and the findings of
the audit.

The nature and intensity of auditing tasks in respect of indi-
9.
vidual establishments shall depend upon the assessed risk. To this
end, the competent authority shall regularly assess:

(a) public and, where appropriate, animal health risks;

(b)

in the case of slaughterhouses, animal welfare aspects;

(c)

the type and throughput of the processes carried out;

and

(d)

the food business operator’s past record as regards compli-
ance with food law.

Article 5

Fresh meat

Member States shall ensure that official controls with respect to
fresh meat take place in accordance with Annex I.

1. The official veterinarian shall carry out inspection tasks in
slaughterhouses, game handling establishments and cutting
plants placing fresh meat on the market in accordance with
the general requirements of Section I, Chapter II, of Annex I,
and with the specific requirements of Section IV, in particu-
lar as regards:

(a)

food chain information;

(b) ante-mortem inspection;

(c) animal welfare;

(d) post-mortem inspection;

(e)

specified risk material and other animal by-products;

and

(f)

laboratory testing.

out in slaughterhouses and game-handling establishments in
accordance with Section I, Chapter III, of Annex I. Health
marks shall be applied by, or under the responsibility of, the
official veterinarian when official controls have not identified
any deficiencies that would make the meat unfit for human
consumption.

3. After carrying out the controls mentioned in points 1 and 2,
the official veterinarian shall take appropriate measures as set
out in Annex I, Section II, in particular as regards:

(a)

the communication of inspection results;

(b) decisions concerning food chain information;

(c) decisions concerning live animals;

(d) decisions concerning animal welfare;

and

(e) decisions concerning meat.

4. Official auxiliaries may assist the official veterinarian with
official controls carried out in accordance with Sections I
and II of Annex I as specified in Section III, Chapter I. In that
case, they shall work as part of an independent team.

5.

(a) Member States shall ensure that they have sufficient offi-
cial staff to carry out the official controls required under
Annex I with the frequency specified in Section III,
Chapter II.

(b) A risk-based approach shall be followed to assess the
number of official staff that need to be present on the
slaughter line in any given slaughterhouse. The number
of official staff involved shall be decided by the compe-
tent authority and shall be such that all the requirements
of this Regulation can be met.

6.

(a) Member States may allow slaughterhouse staff to assist
with official controls by carrying out certain specific
tasks, under the supervision of the official veterinarian,
in relation to the production of meat from poultry and
lagomorphs in accordance with Annex I, Section III,
Chapter III, part A. If they do so, they shall ensure that
staff carrying out such tasks:

(i)

are qualified and undergo training in accordance
with those provisions;

(ii) act independently from production staff;

2. The health marking of carcases of domestic ungulates, farmed
game mammals other than lagomorphs, and large wild game,
as well as half-carcases, quarters and cuts produced by cut-
ting half-carcases into three wholesale cuts, shall be carried

and

(iii) report any deficiency to the official veterinarian.

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(b) Member States may also allow slaughterhouse staff to
carry out specific sampling and testing tasks in accor-
dance with Annex I, Section III, Chapter III, Part B.

(d) authorisation to use products of animal origin for purposes
other than those for which they were originally intended;

7. Member States shall ensure that official veterinarians and offi-
cial auxiliaries are qualified and undergo training in accor-
dance with Annex I, Section III, Chapter IV.

Article 6

Live bivalve molluscs

Member States shall ensure that the production and placing on
the market of live bivalve molluscs, live echinoderms, live tuni-
cates and live marine gastropods undergo official controls as
described in Annex II.

Article 7

Fishery products

Member States shall ensure that official controls with respect to
fishery products take place in accordance with Annex III.

Article 8

Raw milk and dairy products

Member States shall ensure that official controls with respect to
raw milk and dairy products take place in accordance with
Annex IV.

Article 9

Action in the case of non-compliance

1. When the competent authority identifies non-compliance
with the Regulations referred to in Article 4(2)(a) and (b), it shall
take action to ensure that the food business operator remedies the
situation. When deciding which action to take, the competent
authority shall take account of the nature of the non-compliance
and the food business operator’s past record with regard to
non-compliance.

(e)

the suspension of operations or closure of all or part of the
food business concerned for an appropriate period of time;

(f)

the suspension or withdrawal of the establishment’s approval;

(g)

in the case of consignments from third countries, seizure fol-
lowed by destruction or re-dispatch;

(h) any other measure that the competent authority deems

appropriate.

The competent authority shall provide the food business

3.
operator concerned, or a representative, with:

(a) written notification of its decision concerning the action to
be taken in accordance with paragraph 1, together with the
reasons for the decision;

and

(b)

information on rights of appeal against such decisions and of
the applicable procedure and time limits.

Where appropriate, the competent authority shall also notify the
competent authority of the Member State of dispatch of its
decision.

CHAPTER III

PROCEDURES CONCERNING IMPORTS

Article 10

General principles and conditions

Such action shall include, where appropriate, the following

2.
measures:

To ensure the uniform application of the principles and condi-
tions laid down in Article 11 of Regulation (EC) No 178/2002 the
procedures laid down in this c+hapter shall apply.

(a)

the imposition of sanitation procedures or any other correc-
tive action deemed necessary to ensure the safety of products
of animal origin or compliance with the relevant legal
requirements;

(b)

the restriction or prohibition of the placing on the market,
import or export of products of animal origin;

(c) monitoring or, if necessary, ordering the recall, withdrawal

and/or destruction of products of animal origin;

Article 11

Lists of third countries and parts of third countries from
which imports of specified products of animal origin
are permitted

1.
Products of animal origin shall be imported only from a
third country or a part of third country that appears on a list
drawn up and updated in accordance with the procedure referred
to in Article 19(2).

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A third country shall appear on such lists only if a Commu-
2.
nity control in that country has taken place and demonstrates that
the competent authority provides appropriate guarantees as speci-
fied in paragraph 4. However, a third country may appear on such
lists without a Community control having taken place there if:

(a)

the risk determined in accordance with Article 18(18) does
not warrant it;

and

(b)

it is determined, when deciding to add a particular third
country to a list in accordance with paragraph 1, that other
information indicates that the competent authority provides
the necessary guarantees.

3.
Lists drawn up in accordance with this Article may be com-
bined with other lists drawn up for public and animal health
purposes.

4. When lists are drawn up or updated, particular account shall
be taken of the following criteria:

(f) where applicable, the situation regarding animal health and
procedures for notifying the Commission and relevant inter-
national bodies of outbreaks of animal diseases;

(g)

the extent and operation of official controls on imports of
animals and products of animal origin;

(h)

(i)

the assurances which the third country can give regarding
to, Community
compliance with,
requirements;

equivalence

or

the hygiene conditions of production, manufacture, han-
dling, storage and dispatch actually applied to products of
animal origin destined for the Community;

(j)

any experience of marketing of the product from the third
country and the results of any import controls carried out;

(k)

the results of Community controls carried out in the third
country, in particular the results of the assessment of the
competent authorities, and the action that competent
authorities have taken in the light of any recommendations
addressed to them following a Community control;

(a)

the legislation of the third country on:

(l)

the existence, implementation and communication of an
approved zoonoses control programme;

(i) products of animal origin,

and

(ii)

the use of veterinary medicinal products, including rules
on their prohibition or authorisation, their distribution,
their placing on the market and the rules covering
administration and inspection;

and

(iii) the preparation and use of feedingstuffs, including the
procedures for using additives and the preparation and
use of medicated feedingstuffs, as well as the hygiene
quality of the raw materials used for preparing feeding-
stuffs and of the final product;

(b)

the organisation of the third countries’ competent authori-
ties, their powers and independence, the supervision to which
they are subject and the authority that they have effectively
to enforce the applicable legislation;

(c)

the training of staff in the performance of official controls;

(d)

the resources, including diagnostic facilities available to com-
petent authorities;

(m) the existence,

implementation and communication of an

approved residue control programme.

5.
The Commission shall arrange for up-to-date versions of all
lists drawn up or updated in accordance with this Article to be
available to the public.

Article 12

List of establishments from which imports of specified
products of animal origin are permitted

1.
Products of animal origin may be imported into the Com-
munity only if they have been dispatched from, and obtained or
prepared in, establishments that appear on lists drawn up and
updated in accordance with this Article, except:

(a) when, on a case-by-case basis, it is decided, in accordance
with the procedure referred to in Article 19(2), that the guar-
antees that a specified third country provides in respect of
imports of specified products of animal origin are such that
the procedure provided for in this Article is unnecessary to
ensure compliance with the requirements of paragraph 2;

and

(e)

the existence and operation of documented control proce-
dures and control systems based on priorities;

(b)

in the cases specified in Annex V.

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In addition, fresh meat, minced meat, meat preparations, meat
products and mechanically separated meat
(MSM) may be
imported into the Community only if they have been manufac-
tured from meat obtained in slaughterhouses and cutting plants
appearing on lists drawn up and updated in accordance with this
Article or in approved Community establishments.

2.
An establishment may be placed on such a list only if the
competent authority of the third country of origin guarantees
that:

(a)

that establishment, together with any establishments han-
dling raw material of animal origin used in the manufacture
of the products of animal origin concerned, complies with
relevant Community requirements,
in particular those of
Regulation (EC) No 853/2004, or with requirements that
were determined to be equivalent to such requirements when
deciding to add that third country to the relevant list in
accordance with Article 11;

(b) an official inspection service in that third country supervises
the establishments and makes available to the Commission,
where necessary, all relevant information on establishments
furnishing raw materials;

and

(c)

it has real powers to stop the establishments from exporting
to the Community in the event that the establishments fail to
meet the requirements referred to under (a).

3.
The competent authorities of third countries appearing on
lists drawn up and updated in accordance with Article 11 shall
guarantee that lists of the establishments referred to in para-
graph 1 are drawn up, kept up-to-date and communicated to the
Commission.

4.

(a) The Commission shall provide the contact points that
Member States have designated for this purpose with
regular notifications concerning new or updated lists
that it has received from the competent authorities of
concerned in accordance with
third countries
paragraph 3.

The Commission shall arrange for up-to-date versions of all

5.
lists to be available to the public.

Article 13

Live bivalve molluscs, echinoderms, tunicates and
marine gastropods

Notwithstanding Article 12(1)(b),

1.
live bivalve molluscs,
echinoderms, tunicates and marine gastropods shall come from
production areas in third countries that appear on lists drawn up
and updated in accordance with Article 12.

The requirement of paragraph 1 shall not apply to pec-
2.
tinidae harvested outside classified production areas. However,
official controls with respect to pectinidae shall take place in
accordance with Annex II, Chapter III.

3.

(a) Before the lists referred to in paragraph 1 are drawn up,
particular account shall be taken of the guarantees that
the competent authority of the third country can give
concerning compliance with the requirements of this
Regulation on the classification and control of produc-
tion zones.

(b) An on-the-spot Community inspection visit shall take

place before such lists are drawn up unless:

(i)

(ii)

risk

the
determined
Article 18(18) does not warrant it;

in

accordance with

and

it is determined, when deciding to add a particular
production area to a list in accordance with para-
graph 1, that other information indicates that the
competent
the necessary
guarantees.

authority provides

The Commission shall arrange for up-to-date versions of all
4.
lists drawn up or updated in accordance with this Article to be
available to the public.

Article 14

Documents

(b)

If no Member State objects to the new or updated list
within 20 working days of the Commission’s notifica-
tion, imports shall be authorised from establishments
appearing on the list 10 working days after the day on
which the Commission makes it available to the public.

(c) The Commission shall, whenever at least one Member
State makes written comments, or whenever it consid-
ers that the modification of a list is necessary in the light
of relevant information such as Community inspection
reports or a notification under the rapid alert system,
inform all Member States and include the point on
agenda of the next meeting of the relevant section of the
Standing Committee on the Food Chain and Animal
Health for decision, where appropriate, in accordance
with the procedure referred to in Article 19(2).

1.
A document meeting the requirements set out in Annex VI
shall accompany consignments of products of animal origin when
they are imported into the Community.

2.

The document shall certify that the products satisfy:

(a)

the requirements laid down for such products according to
Regulation (EC) No 852/2004 and Regulation (EC)
No 853/2004 or provisions that are equivalent to those
requirements;

and

(b) any special import conditions established in accordance with

Article 18(19).

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Documents may include details required in accordance with
3.
other Community legislation on public and animal health matters.

4.
Exemptions from paragraph 1 may be granted in accor-
dance with the procedure referred to in Article 19(2) when it is
possible to obtain the guarantees referred to in paragraph 2 of this
Article in another manner.

Article 15

Special provisions for fishery products

The procedures laid down in this Chapter do not apply to
1.
fresh fishery products landed in the Community directly from a
fishing vessel flying the flag of a third country.

Official controls with respect to such fishery products shall take
place in accordance with Annex III.

2.

(a) Fishery products imported from a factory or freezer ves-
sel flying the flag of a third country shall come from
vessels that appear on a list drawn up and updated in
accordance with the procedure set out in Article 12(4).

(b) However, by way of exemption from Article 12(2)(b), a

vessel may also be included on such lists:

which the vessel is flying and from the competent
authority of a Member State, to which the former
competent authority has delegated responsibility
for the inspection of the vessel concerned, on con-
dition that:

— all fishery products from the vessel concerned
that are destined for placing on the market in
the Community are landed directly in that
Member State,

— the competent authority of that Member State
has inspected the vessel and has declared that
it complies with Community requirements,

and

— the competent authority of that Member State
has declared that it will regularly inspect the
vessel to ensure that it continues to comply
with Community requirements.

(c) The Commission shall arrange for up-to-date versions
of all lists drawn up or updated in accordance with this
Article to be available to the public.

(i) on the basis of a joint communication from the
competent authority of the third country the flag of
which the vessel is flying and from the competent
authority of another third country to which the
former competent authority has delegated respon-
sibility for the inspection of the vessel concerned,
on condition that:

3. When fishery products are imported directly from a fishing
or freezer vessel, a document signed by the captain may replace
the document required under Article 14.

4.
Detailed rules for the implementation of this Article may be
laid down in accordance with the procedure referred to in
Article 19(2).

— that third country appears on the list of third
countries, drawn up in accordance with
Article 11, from which imports of fisheries
products are permitted,

— all fishery products from the vessel concerned
that are destined for placing on the market in
the Community are landed directly in that
third country,

— the competent authority of that third country
has inspected the vessel and has declared that
it complies with Community requirements,

and

— the competent authority of that third country
has declared that it will regularly inspect the
vessel to ensure that it continues to comply
with Community requirements;

or

(ii) on the basis of a joint communication from the
competent authority of the third country the flag of

CHAPTER IV

FINAL PROVISIONS

Article 16

Implementing measures and transitional measures

Implementing measures and transitional arrangements may be
laid down in accordance with the procedure referred to in
Article 19(2).

Article 17

Amendment and adaptation of the Annexes

1.
Annexes I, II, III, IV, V and VI may be amended or supple-
mented to take account of scientific and technical progress in
accordance with the procedure referred to in Article 19(2).

2.
Exemptions from Annexes I, II, III, IV, V and VI may be
granted in accordance with the procedure referred to in
Article 19(2), provided that they do not affect the achievement of
the objectives of this Regulation.

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3. Member States may, without compromising achievement of
the objectives of this Regulation, adopt, in accordance with para-
graphs 4 to 7, national measures adapting the requirements laid
down in Annex I.

4.

The national measures referred to in paragraph 3 shall:

A Member State may adopt national measures adapting the

7.
requirements of Annex I only:

(a)

in compliance with a decision adopted in accordance with
paragraph 6;

(a) have the aim of:

(i)

enabling the continued use of traditional methods at any
of the stages of production, processing or distribution of
food;

(ii) accommodating the needs of food businesses with a low
throughput or that are situated in regions that are sub-
ject to special geographic constraints;

or

(iii) permitting pilot projects to take place in order to try out

new approaches to hygiene controls on meat;

(b) concern in particular the following elements of Annex I:

(i)

food chain information;

(ii)

the
presence
establishments.

of

the

competent

authority

in

5.
Any Member State wishing to adopt national measures as
referred to in paragraph 3 shall notify the Commission and other
Member States. Each notification shall:

(a) provide a detailed description of the requirements that that
Member State considers need to be adapted and the nature of
the adaptation sought;

(b) describe the establishments concerned;

(c)

explain the reasons for the adaptation, including, where rel-
evant, by providing a summary of the hazard analysis carried
out and any measures to be taken to ensure that the adapta-
tion will not compromise the objectives of this Regulation;

and

(d) give any other relevant information.

The other Member States shall have three months from the
6.
receipt of a notification referred to in paragraph 5 to send written
comments to the Commission. The Commission may, and when
it receives written comments from one or more Member States
shall, consult Member States within the committee referred to in
Article 19(1). The Commission may decide, in accordance with
the procedure referred to in Article 19(2), whether the envisaged
measures may be implemented subject, if necessary, to appropri-
ate amendments. Where appropriate, the Commission may pro-
pose general measures in accordance with paragraphs 1 or 2 of
this Article.

(b)

if, one month after the expiry of the period referred to in
paragraph 6, the Commission has not informed Member
States that it has received written comments or that it intends
to propose the adoption of a decision in accordance with
paragraph 6.

8. When a Member State adopts national measures imple-
menting a pilot project to try out new approaches to hygiene con-
trols on meat in accordance with paragraphs 3 to 7, the Member
State shall communicate the results to the Commission as soon as
they are available. The Commission shall then consider propos-
ing general measures in accordance with paragraph 1.

Article 18

Specific decisions

Without prejudice to the generality of Article 16 and Article 17(1),
implementing measures may be laid down, or amendments to
Annexes I, II, III, IV, V or VI adopted, in accordance with the pro-
cedure referred to in Article 19(2), to specify:

1.

tests to assess the performance of food business operators
and their staff;

2.

the method of communicating inspection results;

3.

criteria to determine when, on the basis of a risk analysis, the
official veterinarian need not be present in slaughterhouses
and game handling establishments throughout ante-mortem
and post-mortem inspection;

4.

rules concerning the content of tests for official veterinarians
and official auxiliaries;

5. microbiological criteria for process control in relation to

hygiene in establishments;

6.

7.

alternative procedures, serological or other laboratory tests
that provide guarantees at least equivalent to specific post-
mortem inspection procedures described in Annex I, Sec-
tion IV, and may therefore replace them, if the competent
authority so decides;

circumstances in which certain of the specific post-mortem
inspection procedures described in Annex I, Section IV, are
not necessary, having regard to the holding, region or coun-
try of origin and to the principles of risk analysis,

8.

rules for laboratory testing;

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9.

the cold treatment to be applied to meat in relation to cys-
ticercosis and trichinosis;

established for a single product of animal origin or for group
of products. They may apply to a single third country, to
regions of a third country, or to a group of third countries;

10. conditions under which holdings and regions can be certi-

and

fied as officially free of cysticercus or trichinae;

11. methods to be applied when examining for the conditions

referred to in Annex I, Section IV, Chapter IX;

12. for fattening pigs, criteria for controlled housing conditions

and integrated production systems;

13. criteria for the classification of production and relaying areas
for live bivalve molluscs in cooperation with the relevant
Community Reference Laboratory, including:

(a)

limit values and analysis methods for marine biotoxins,

(b) virus testing procedures and virological standards,

and

(c)

sampling plans and the methods and analytical toler-
ances to be applied to check compliance with the criteria;

14. organoleptic criteria for the evaluation of the freshness of

fishery products;

15. analytical limits, methods of analysis and sampling plans for
the official controls on fishery products required under
Annex III, including with regard to parasites and environ-
mental contaminants;

16. the method by which the Commission will make lists of third
countries and establishments in third countries available to
the public pursuant to Articles 11, 12, 13 and 15;

20. the conditions governing imports of products of animal ori-
gin from a third country or a region of a third country pur-
suant to the implementation of an equivalence agreement, or
to a satisfactory audit, recognising that measures applied in
that third country or region offer guarantees equivalent to
those applied in the Community, if the third country supplies
objective proof in this respect.

Article 19

Committee procedure

1.
The Commission shall be assisted by the Standing Commit-
tee on the Food Chain and Animal Health instituted by Article 58
of Regulation (EC) No 178/2002.

2. Where reference is made to this paragraph, Articles 5 and 7
of Decision 1999/468/EC shall apply, having regard to the pro-
visions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

3.

The Committee shall adopt its Rules of Procedure.

Article 20

Consultation of the European Food Safety Authority

The Commission shall consult the European Food Safety Author-
ity on matters falling within the scope of this Regulation when-
ever necessary and, in particular:

1.

2.

before proposing to modify the specific requirements con-
cerning post-mortem inspection procedures laid down in
Section IV of Annex I;

before proposing to modify the rules of Annex I, Section IV,
Chapter IX, on meat from animals in which post-mortem
inspection has revealed lesions indicating infection with bru-
cellosis or tuberculosis;

17. models for documents and criteria for the use of electronic

documents;

and

18. criteria for determining the risk that particular products of
animal origin imported into the Community present;

19. special import conditions for particular products of animal
origin, taking account of the associated risks, information
that relevant third countries have provided and, where nec-
essary, the results of Community controls carried out in such
third countries. These special import conditions may be

3.

before proposing implementing measures on the matters
referred to in Article 18(5) to (15).

Article 21

Report to the European Parliament and to the Council

1.
The Commission shall, not later than 20 May 2009, submit
a report to the European Parliament and the Council reviewing
the experience gained from the application of this Regulation.

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The Commission shall, if appropriate, accompany the report

2.
with relevant proposals.

(b) Regulation (EC) No 853/2004

Article 22

Entry into force

and

This Regulation shall enter into force on the 20th day after that
of its publication in the Official Journal of the European Union.

It shall apply 18 months after the date on which all of the follow-
ing acts have entered into force:

(c) Directive 2004/41/EC of the European Parliament and of the
Council of 29 April 2004 repealing certain directives con-
cerning food hygiene and health conditions for the produc-
tion and placing on the market of certain products of animal
origin intended for human consumption (1).

(a) Regulation (EC) No 852/2004;

However, it shall apply no earlier than 1 January 2006.

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

Done at Strasbourg, 29 April 2004.

For the European Parliament
The President
P. COX

For the Council
The President
M. McDOWELL

(1) OJ L 157, 30.4.2004, p. 33.

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ANNEX I

FRESH MEAT

SECTION I: TASKS OF THE OFFICIAL VETERINARIAN

CHAPTER I: AUDITING TASKS

1.

In addition to the general requirements of Article 4(4) concerning audits of good hygiene practices, the official veteri-
narian is to verify continuous compliance with food business operators’ own procedures concerning any collection,
transport, storage, handling, processing and use or disposal of animal by-products, including specified risk material,
for which the food business operator is responsible.

2.

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

(a)

does not contain patho-physiological abnormalities or changes;

(b) does not bear faecal or other contamination;

and

(c)

does not contain specified risk material, except as provided for under Community legislation, and has been pro-
duced in accordance with Community legislation on TSEs.

CHAPTER II: INSPECTION TASKS

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.

A.

Food chain information

1.

The official veterinarian is to check and analyse relevant information from the records of the holding of prov-
enance of animals intended for slaughter and to take account of the documented results of this check and analysis
when carrying out ante- and post-mortem inspection.

2. When carrying out inspection tasks, the official veterinarian is to take account of official certificates accompany-
ing animals, and any declarations made by veterinarians carrying out controls at the level of primary production,
including official veterinarians and approved veterinarians.

3. When food business operators in the food chain take additional measures to guarantee food safety by implement-
ing integrated systems, private control systems, independent third party certification or by other means, and when
these measures are documented and animals covered by these schemes clearly identifiable, the official veterinar-
ian may take this into account when carrying out inspection tasks and reviewing the HACCP-based procedures.

B. Ante-mortem inspection

1.

Subject to paragraphs 4 and 5:

(a)

the official veterinarian is to carry out an ante-mortem inspection of all animals before slaughter;

(b)

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.

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

any sign:

(a)

that welfare has been compromised;

or

(b) of any condition which might adversely affect human or animal health, paying particular attention to the
detection of zoonotic diseases and diseases on List A or, where appropriate, List B of the Office International
des Epizooties (World organisation for animal health, OIE).

In addition to routine ante-mortem inspection, the official veterinarian is to carry out a clinical inspection of all
animals that the food business operator or an official auxiliary may have put aside.

In the case of emergency slaughter outside the slaughterhouse and of hunted wild game, the official veterinarian
at the slaughterhouse or game handling establishment is to examine the declaration accompanying the body of
the animal issued by the veterinarian or the trained person in accordance with Regulation (EC) No 853/2004.

3.

4.

5. Where provided for in Section III, Chapter II, or in Section IV, ante-mortem inspection may be carried out at the
holding of provenance. In such cases, the official veterinarian at the slaughterhouse need carry out ante-mortem
inspection only when and to the extent specified.

C. Animal welfare

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.

D.

Post-mortem inspection

1.

Carcases and accompanying offal are to be subjected without delay after slaughter to post-mortem inspection. All
external surfaces are to be viewed. Minimal handling of the carcase and offal or special technical facilities may be
required for that purpose. Particular attention is to be paid to the detection of zoonotic diseases and diseases on
OIE List A and, where appropriate, OIE List B. The speed of the slaughter line and the number of inspection staff
present are to be such as to allow for proper inspection.

2. Additional examinations are to take place, such as palpation and incision of parts of the carcase and offal and labo-

ratory tests, whenever considered necessary:

(a)

to reach a definitive diagnosis;

or

(b)

to detect the presence of:

(i)

an animal disease,

(ii)

residues or contaminants in excess of the levels laid down under Community legislation,

(iii) non-compliance with microbiological criteria,

or

(iv) 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.

3.

The official veterinarian is to require carcases of domestic solipeds, bovine animals over six months old, and
domestic swine over four weeks old to be submitted for post-mortem inspection split lengthways into half car-
cases down the spinal column. If the inspection so necessitates, the official veterinarian may also require any head
or any carcase to be split lengthways. However, to take account of particular eating habits, technological devel-
opments or specific sanitary situations, the competent authority may authorise the submission for inspection of
carcases of domestic solipeds, bovine animals over six months old, and domestic swine over four weeks old, not
split in half.

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4. During the inspection, precautions must be taken to ensure that contamination of the meat by actions such as

palpation, cutting or incision is kept to a minimum.

5.

In the event of an emergency slaughter, the carcase shall be subjected to post-mortem examination as soon as pos-
sible in accordance with paragraphs 1 to 4 before it is released for human consumption.

E.

Specified risk material and other animal by-products

In accordance with specific Community rules on specified risk material and other animal by-products, the official vet-
erinarian is to check the removal, separation and, where appropriate, marking of such products. The official veterinar-
ian is to ensure that the food business operator takes all necessary measures to avoid contaminating meat with speci-
fied risk material during slaughter (including stunning) and removal of specified risk material.

F.

Laboratory testing

1.

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

(a)

the monitoring and control of zoonoses and zoonotic agents;

(b)

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);

(c)

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

(d)

the detection of OIE List A and, where appropriate, OIE List B diseases.

2.

The official veterinarian is also to ensure that any other necessary laboratory testing takes place.

CHAPTER III: HEALTH MARKING

1.

The official veterinarian is to supervise health marking and the marks used.

2.

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

(a)

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 Regu-
lation 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

(b) 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.

3.

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

(a)

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 AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE
and UK;

(1) 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).
(2) 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).

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(b)

the mark must indicate the approval number of the slaughterhouse;

and

(c) when applied in a slaughterhouse within the Community, the mark must include the abbreviation CE, EC, EF, EG,

EK or EY.

Letters must be at least 0,8 cm high and figures at least 1 cm high. The dimensions and characters of the mark may be
reduced for health marking of lamb, kids and piglets.

The colours used for health marking must be authorised in accordance with Community rules on the use of colouring
substances in foodstuffs.

The health mark may also include an indication of the official veterinarian who carried out the health inspection of the
meat. Competent authorities and food business operators may continue to use equipment that they ordered before entry
into force of this Regulation until it is exhausted or requires replacement.

4.

5.

6.

7. Meat from animals having undergone emergency slaughter outside the slaughterhouse must bear a special health mark,
which cannot be confused either with the health mark provided for in this Chapter or with the identification mark pro-
vided for in Annex II, Section I, to Regulation (EC) No 853/2004.

8. Meat from unskinned wild game cannot bear a health mark unless, after skinning in a game handling establishment, it

has undergone post-mortem inspection and been declared fit for human consumption.

9.

This Chapter is to apply without prejudice to animal health rules on health marking.

SECTION II: ACTION FOLLOWING CONTROLS

CHAPTER I: COMMUNICATION OF INSPECTION RESULTS

1.

The official veterinarian is to record and to evaluate the results of inspection activities.

2.

(a)

If inspections reveal the presence of any disease or condition that might affect public or animal health, or com-
promise animal welfare, the official veterinarian is to inform the food business operator.

(b) When the problem identified arose during primary production, the official veterinarian is to inform the veteri-
narian 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.

(c)

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.

3.

The results of inspections and tests are to be included in relevant databases.

4. When the official veterinarian, while carrying out ante-mortem or post-mortem inspection or any other inspection
activity, suspects the presence of an infectious agent mentioned on OIE List A or, where appropriate, OIE List B, the
official veterinarian must immediately notify the competent authority and both must take all necessary measures and
precautions to prevent the possible spread of the infectious agent in accordance with applicable Community legislation.

CHAPTER II: DECISIONS CONCERNING FOOD CHAIN INFORMATION

1.

The official veterinarian is to verify that animals are not slaughtered unless the slaughterhouse operator has been pro-
vided with and checked relevant food chain information.

2. However, the official veterinarian may allow animals to undergo slaughter in the slaughterhouse even if the relevant
food chain information is not available. In this case, all relevant food chain information must be supplied before the
carcase is approved for human consumption. Pending a final judgement, such carcases and related offal must be stored
separately from other meat.

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3. Notwithstanding paragraph 2, when relevant food chain information is not available within 24 hours of an animal’s
arrival at the slaughterhouse, all meat from the animal is to be declared unfit for human consumption. If the animal
has not yet been slaughtered, it is to be killed separately from other animals.

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

(a)

animals come from a holding or an area subject to a movement prohibition or other restriction for reasons of
animal or public health;

(b)

rules on the use of veterinary medicinal products have not been complied with;

or

(c)

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 vet-
erinarian considers it necessary, official controls are to be carried out on the holding of provenance.

5.

The competent authority is to take appropriate action if it discovers that the accompanying records, documentation or
other information do not correspond with the true situation on the holding of provenance or the true condition of the
animals or aim deliberately to mislead the official veterinarian. The competent authority is to take action against the
food business operator responsible for the holding of provenance of the animals, or any other person involved. This
action may consist in particular of extra controls. The food business operator responsible for the holding of prov-
enance or any other person involved are to bear the costs of such extra controls.

CHAPTER III: DECISIONS CONCERNING LIVE ANIMALS

1.

The official veterinarian is to verify compliance with the food business operator’s duty pursuant to Regulation (EC)
No 8532004 to ensure that animals accepted for slaughter for human consumption are properly identified. The offi-
cial veterinarian is to ensure that animals whose identity is not reasonably ascertainable are killed separately and
declared unfit for human consumption. Whenever the official veterinarian considers it necessary, official controls are
to be carried out on the holding of provenance.

2. When there are overriding animal welfare considerations, horses may undergo slaughter at the slaughterhouse even if
the legally required information concerning their identity has not been supplied. However, this information must be
supplied before the carcase may be declared fit for human consumption. These requirements also apply in the case of
emergency slaughter of horses outside the slaughterhouse.

3.

The official veterinarian is to verify compliance with the food business operator’s duty under Regulation (EC)
No 853/2004 to ensure that animals that have such hide, skin or fleece conditions that there is an unacceptable risk of
contamination of the meat during slaughter are not slaughtered for human consumption unless they are cleaned
beforehand.

4. Animals with a disease or condition that may be transmitted to animals or humans through handling or eating meat
and, in general, animals showing clinical signs of systemic disease or emaciation, are not to be slaughtered for human
consumption. Such animals must be killed separately, under conditions such that other animals or carcases can not be
contaminated, and declared unfit for human consumption.

5.

The slaughter of animals suspected of having a disease or condition that may adversely affect human or animal health
is to be deferred. Such animals are to undergo detailed ante-mortem examination in order to make a diagnosis. In addi-
tion, the official veterinarian may decide that sampling and laboratory examinations are to take place to supplement
post-mortem inspection. If necessary, the animals are to be slaughtered separately or at the end of normal slaughtering,
taking all necessary precautions to avoid contamination of other meat.

6. Animals that might contain residues of veterinary medicinal products in excess of the levels laid down in accordance
forbidden substances, are to be dealt with in accordance with

with Community legislation, or residues of
Directive 96/23/EC.

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7.

The official veterinarian is to impose the conditions under which animals are to be dealt with under a specific scheme
for the eradication or control of a specific disease, such as brucellosis or tuberculosis, or zoonotic agents such as sal-
monella, under his/her direct supervision. The competent authority is to determine the conditions under which such
animals may be slaughtered. These conditions must have the aim of minimising contamination of other animals and
the meat of other animals.

8. Animals that are presented to a slaughterhouse for slaughter must as a general rule be slaughtered there. However, in
exceptional circumstances, such as a serious breakdown of the slaughter facilities, the official veterinarian may allow
direct movements to another slaughterhouse.

CHAPTER IV: DECISIONS CONCERNING ANIMAL WELFARE

1. When the rules concerning the protection of animals at the time of slaughter or killing are not respected, the official
veterinarian is to verify that the food business operator immediately takes necessary corrective measures and prevents
recurrence.

2.

The official veterinarian is to take a proportionate and progressive approach to enforcement action, ranging from issu-
ing directions to slowing down and stopping production, depending on the nature and gravity of the problem.

3. Where appropriate, the official veterinarian is to inform other competent authorities of welfare problems.

4. When the official veterinarian discovers that rules concerning the protection of animals during transport are not being

respected, he or she is to take necessary measures in accordance with the relevant Community legislation.

5. When:

(a)

an official auxiliary is carrying out checks on animal welfare pursuant to Sections III or IV;

and

(b)

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.

CHAPTER V: DECISIONS CONCERNING MEAT

1. Meat is to be declared unfit for human consumption if it:

(a)

derives from animals that have not undergone ante-mortem inspection, except for hunted wild game;

(b) 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;

(c)

derives from animals which are dead before slaughter, stillborn, unborn or slaughtered under the age of seven days;

(d)

results from the trimming of sticking points;

(e)

(f)

derives from animals affected by an OIE List A or, where appropriate, OIE List B disease, unless otherwise pro-
vided for in Section IV;

derives from animals affected by a generalised disease, such as generalised septicaemia, pyaemia, toxaemia or
viraemia;

(g)

is not in conformity with microbiological criteria laid down under Community legislation to determine whether
food may be placed on the market;

(h)

exhibits parasitic infestation, unless otherwise provided for in Section IV;

(i)

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;

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(j) 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;

(k)

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 met-
als in the environment;

(l)

has been treated illegally with decontaminating substances;

(m) has been treated illegally with ionising or UV-rays;

(n)

contains foreign bodies (except, in the case of wild game, material used to hunt the animal);

(o)

exceeds the maximum permitted radioactivity levels laid down under Community legislation;

(p)

indicates patho-physiological changes, anomalies in consistency, insufficient bleeding (except for wild game) or
organoleptic anomalies, in particular a pronounced sexual odour;

(q)

derives from emaciated animals;

(r)

contains specified risk material, except as provided for under Community legislation;

(s)

shows soiling, faecal or other contamination;

(t)

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;

(u)

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.

2.

The official veterinarian may impose requirements concerning the use of meat derived from animals having undergone
emergency slaughter outside the slaughterhouse.

SECTION III: RESPONSIBILITIES AND FREQUENCY OF CONTROLS

CHAPTER I: OFFICIAL AUXILIARIES

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:

1.

2.

3.

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.

CHAPTER II: FREQUENCY OF CONTROLS

1.

The competent authority is to ensure that at least one official veterinarian is present:

(a)

in slaughterhouses, throughout both ante-mortem and post-mortem inspection;

and

(b)

in game handling establishments, throughout post-mortem inspection.

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

(a)

the official veterinarian need not be present at the time of ante-mortem inspection in the slaughterhouse if:

(i)

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,

(ii)

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

(iii)

the official veterinarian regularly satisfies himself/herself that the official auxiliary is carrying out such checks
properly;

(b)

the official veterinarian need not be present at all times during post-mortem inspection if:

(i)

an official auxiliary carries out post-mortem inspection and puts aside meat with abnormalities and all other
meat from the same animal,

(ii)

the official veterinarian subsequently inspects all such meat,

and

(iii)

the official auxiliary documents his/her procedures and findings in a manner that allows the official veteri-
narian 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.

3.

The flexibility provided for in paragraph 2 does not apply:

(a)

to animals that have undergone emergency slaughter;

(b)

to animals suspected of having a disease or condition that may adversely affect human health;

(c)

to bovine animals from herds that have not been declared officially free of tuberculosis;

(d)

to bovine, ovine and caprine animals from herds that have not been declared officially free of brucellosis;

(e)

in the case of an outbreak of a disease listed on OIE List A or, where appropriate, OIE List B. This concerns ani-
mals susceptible to the particular disease in question that come from the particular region as defined in Article 2
of Council Directive 64/432/EEC (1);

(f) when stricter controls are necessary to take account of emerging diseases or particular OIE List B diseases.

4.

In cutting plants, the competent authority is to ensure that an official veterinarian or an official auxiliary is present when
meat is being worked on with a frequency appropriate to achieving the objectives of this Regulation.

(1) OJ L 121, 29.7.1964, p. 1977/64. Directive as last amended by Commission Regulation (EC) No 21/2004 (OJ L 5, 9.1.2004, p. 8).

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CHAPTER III: INVOLVEMENT OF SLAUGHTERHOUSE STAFF

A.

SPECIFIC TASKS CONCERNING THE PRODUCTION OF MEAT FROM POULTRY AND LAGOMORPHS

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:

(a) Where 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
who have been trained in the same way as the official assistants and have passed the same examination to carry
out tasks of the official auxiliaries and form part of the competent authority’s independent inspection team, under
the supervision, direction and responsibility of the official veterinarian. In these circumstances, the official veteri-
narian 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 tasks meets the specific cri-
teria laid down by the competent authority, and shall document the results of those performance tests. Detailed
rules for the performance tests shall be laid down in accordance with the procedure set out in Article 18. 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 con-
siders unsatisfactory, this staff shall be replaced by official auxiliaries.

Responsibilities for production and inspection in the establishment must be kept separate and any establishment
wishing to use the establishment’s own inspectors must possess internationally recognised certification.

(b) 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 com-
petent 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.

B.

SPECIFIC SAMPLING AND TESTING TASKS

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.

CHAPTER IV: PROFESSIONAL QUALIFICATIONS

A. OFFICIAL VETERINARIANS

1.

2.

The competent authority may appoint only veterinarians who have passed a test meeting the requirements of para-
graph 2 as official veterinarians.

The competent authority must make arrangements for the test. The test is to confirm knowledge of the following
subjects to the extent necessary depending on the veterinarian’s background and qualifications:

(a)

national and Community legislation on veterinary public health, food safety, animal health, animal welfare
and pharmaceutical substances;

(b) principles of the common agricultural policy, market measures, export refunds and fraud detection (includ-

ing the global context: WTO, SPS, Codex Alimentarius, OIE);

(c)

essentials of food processing and food technology;

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(d) principles, concepts and methods of good manufacturing practice and quality management;

(e)

pre-harvest quality management (good farming practices);

(f)

promotion and use of food hygiene, food related safety (good hygiene practices);

(g) principles, concepts and methods of risk-analysis;

(h) principles, concepts and methods of HACCP, use of HACCP throughout the food production food chain;

(i)

prevention and control of food-borne hazards related to human health;

(j)

population dynamics of infection and intoxication;

(k)

diagnostic epidemiology;

(l) monitoring and surveillance systems;

(m) auditing and regulatory assessment of food safety management systems;

(n) principles and diagnostic applications of modern testing methods;

(o)

information and communication technology as related to veterinary public health;

(p) data-handling and applications of biostatistics;

(q)

investigations of outbreaks of food-borne diseases in humans;

(r)

relevant aspects concerning TSEs;

(s)

animal welfare at the level of production, transport and slaughter;

(t)

environmental issues related to food production (including waste management);

(u) precautionary principle and consumer concerns;

and

(v) 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 con-
tinuing education resulting in a postgraduate qualification, it may waive the requirement for a test.

3.

The veterinarian is to have aptitude for multidisciplinary cooperation.

4.

5.

In addition, each official veterinarian is to undergo practical training for a probationary period of at least 200 hours
before starting to work independently. During this period the probationer is to work under the supervision of
existing official veterinarians in slaughterhouses, cutting plants, inspection posts for fresh meat and on holdings.
The training is to concern the auditing of food safety management systems in particular.

The official veterinarian is to maintain up-to-date knowledge and to keep abreast of new developments through
regular continuing education activities and professional literature. The official veterinarian is, wherever possible,
to undertake annual continuing education activities.

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6.

Veterinarians already appointed as official veterinarians must have adequate knowledge of the subjects mentioned
in paragraph 2. Where necessary, they are to acquire this knowledge through continuing education activities. The
competent authority is to make adequate provision in this regard.

7. Notwithstanding paragraphs 1 to 6, Member States may lay down specific rules for official veterinarians working

on a part-time basis who are responsible for inspecting small businesses

B. OFFICIAL AUXILIARIES

1.

2.

3.

4.

The competent authority may appoint as official auxiliaries only persons who have undergone training and passed
a test in accordance with the following requirements.

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

(a)

at least 500 hours of theoretical training and at least 400 hours of practical training, covering the areas speci-
fied in paragraph 5;

and

(b)

such additional training as is required to enable official auxiliaries to undertake their duties competently.

The practical training referred to in paragraph 2(a) is to take place in slaughterhouses and cutting plants, under
the supervision of an official veterinarian, and on holdings and in other relevant establishments.

Training and tests are to concern principally red meat or poultrymeat. However, persons who undergo training
for one of the two categories and passed the test need only undergo abridged training to pass the test for the other
category. Training and test should cover wild game, farmed game and lagomorphs, where appropriate.

5.

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

(a)

in relation to holdings:

(i)

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;

(ii) practical part:

— visits to holdings of different types and using different rearing methods,

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— visits to production establishments,

— observation of the loading and unloading of animals,

— laboratory demonstrations,

— veterinary checks,

— documentation;

(b)

in relation to slaughterhouses and cutting plants:

(i)

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, pack-

aging 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;

(ii) practical part:

— animal identification,

— age checks,

— inspection and assessment of slaughtered animals,

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— 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,
procedures,

including the audit of the good hygiene practices and the HACCP-based

— recording the results of ante-mortem inspection,

— sampling,

— traceability of meat,

— documentation.

6. Official auxiliaries are to maintain up-to-date knowledge and to keep abreast of new developments through regu-
lar continuing education activities and professional literature. The official auxiliary is, wherever possible, to under-
take annual continuing education activities.

7.

Persons already appointed as official auxiliaries must have adequate knowledge of the subjects mentioned in para-
graph 5. Where necessary, they are to acquire this knowledge through continuing education activities. The com-
petent authority is to make adequate provision in this regard.

8. However, when official auxiliaries carry out only sampling and analysis in connection with examinations for tri-

chinosis, the competent authority need only ensure that they receive training appropriate to these tasks.

SECTION IV: SPECIFIC REQUIREMENTS

CHAPTER I: DOMESTIC BOVINE ANIMALS

A.

BOVINE ANIMALS UNDER SIX WEEKS OLD

Carcases and offal of bovine animals under six weeks old are to undergo the following post-mortem inspection
procedures:

1.

2.

visual inspection of the head and throat; incision and examination of the retropharyngeal lymph nodes (Lnn ret-
ropharyngiales); inspection of the mouth and fauces; palpation of the tongue; removal 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, per-
pendicular to their main axes; these incisions are not necessary where the lungs are excluded from human
consumption;

3.

visual inspection of the pericardium and heart, the latter being incised lengthwise so as to open the ventricles and
cut through the interventricular septum;

4.

visual inspection of the diaphragm;

5.

6.

visual inspection of the liver and the hepatic and pancreatic lymph nodes, (Lnn portales); palpation and, if neces-
sary, incision of the liver and its lymph nodes;

visual inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn. gas-
trici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph
nodes;

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7.

visual inspection and, if necessary, palpation of the spleen;

8.

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

9.

visual inspection of the pleura and peritoneum;

10. 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.

B.

BOVINE ANIMALS OVER SIX WEEKS OLD

Carcases and offal of bovine animals over six weeks old are to undergo the following post-mortem inspection
procedures:

1.

2.

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. The tonsils must be removed;

inspection of the trachea and oesophagus; visual examination and palpation of the lungs; incision and examina-
tion 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;

3.

visual inspection of the pericardium and heart, the latter being incised lengthways so as to open the ventricles and
cut through the interventricular septum;

4.

visual inspection of the diaphragm;

5.

6.

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. gas-
trici, mesenterici, craniales and caudales); palpation and, if necessary, incision of the gastric and mesenteric lymph
nodes;

7.

visual inspection and, if necessary, palpation of the spleen;

8.

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

9.

visual inspection of the pleura and the peritoneum;

10. visual inspection of the genital organs (except for the penis, if already discarded);

11. 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 lac-
tiferes) and the lymph nodes of the udder must be incised, except when the udder is excluded from human
consumption.

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CHAPTER II: DOMESTIC SHEEP AND GOATS

Carcases and offal of sheep and goats are to undergo the following post-mortem inspection procedures:

1.

2.

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 nec-
essary 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;

3.

visual inspection of the pericardium and heart; in the event of doubt, the heart must be incised and examined;

4.

visual inspection of the diaphragm;

5.

6.

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);

7.

visual inspection and, if necessary, palpation of the spleen;

8.

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

9.

visual inspection of the pleura and peritoneum;

10. visual inspection of the genital organs (except for the penis, if already discarded);

11. visual inspection of the udder and its lymph nodes;

12. visual inspection and palpation of the umbilical region and joints of young animals. In the event of doubt, the umbili-

cal region must be incised and the joints opened; the synovial fluid must be examined.

CHAPTER III: DOMESTIC SOLIPEDS

Carcases and offal of solipeds are to undergo the following post-mortem inspection procedures:

1.

2.

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;

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, perpendicu-
lar to their main axes; however, these incisions are not necessary where the lungs are excluded from human
consumption;

3.

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;

4.

visual inspection of the diaphragm;

5.

6.

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;

7.

visual inspection and, if necessary, palpation of the spleen;

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8.

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

9.

visual inspection of the pleura and peritoneum;

10. visual inspection of the genital organs of stallions (except for the penis, if already discarded) and mares;

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

mary lymph nodes;

12. visual inspection and palpation of the umbilical region and joints of young animals. In the event of doubt, the umbili-

cal region must be incised and the joints opened; the synovial fluid must be examined;

13. 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 shoul-
der. The kidneys must be exposed and examined by incision through the entire kidney.

CHAPTER IV: DOMESTIC SWINE

A. ANTE-MORTEM INSPECTION

1.

The competent authority may decide that pigs intended for slaughter are to be submitted to ante-mortem inspec-
tion at the holding of provenance. In that case, slaughter of a lot of pigs from a holding may be authorised only
if:

(a)

the health certificate provided for in Chapter X, Part A, accompanies them;

and

(b)

the requirements of paragraphs 2 to 5 are complied with.

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

(a)

checks on records or documentation at the holding, including food chain information;

(b)

the examination of the pigs to determine whether:

(i)

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,

(ii)

they show disturbance of general behaviour or signs of disease which may make the meat unfit for
human consumption,

or

(iii)

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.

3. An official veterinarian or an approved veterinarian is to carry out ante-mortem inspection at the holding. The

pigs are to be sent directly to slaughter and not to be mixed with other pigs.

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

(a)

a control of the animals’ identification;

and

(b)

a screening to ascertain whether animal welfare rules have been complied with and whether signs of any con-
dition which might adversely affect human or animal health are present. An official auxiliary may carry out
this screening.

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

(a)

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;

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(b)

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.

B.

POST-MORTEM INSPECTION

1.

Carcases and offal of pigs other than those referred to in paragraph 2 are to undergo the following post-mortem
inspection procedures:

(a)

(b)

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 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 ven-
tricles and cut through the interventricular septum;

(d)

visual inspection of the diaphragm;

(e)

(f)

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;

(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 genital organs (except for the penis, if already discarded);

(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.

2.

The competent authority may decide, on the basis of epidemiological or other data from the holding, that fatten-
ing pigs housed under controlled housing conditions in integrated production systems since weaning need, in
some or all of the cases referred to in paragraph 1, only undergo visual inspection.

CHAPTER V: POULTRY

A. ANTE-MORTEM INSPECTION

1.

The competent authority may decide that poultry intended for slaughter are to be submitted to ante-mortem
inspection at the holding of provenance. In that case, slaughter of a flock of birds from a holding may be autho-
rised only if:

(a)

the health certificate provided for in Chapter X, Part A, accompanies them;

and

(b)

the requirements of paragraphs 2 to 5 are complied with.

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

(a)

checks on records or documentation at the holding, including food chain information;

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(b)

a flock inspection, to determine whether the birds:

(i)

(ii)

have a disease or condition which may be transmitted to animals or humans through handling or eat-
ing 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

(iii)

show evidence that they may contain chemical residues in excess of the levels laid down in Community
legislation, or residues of forbidden substances.

3. An official veterinarian or an approved veterinarian is to carry out ante-mortem inspection at the holding.

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

(a)

a control of the animals’ identification;

and

(b)

a screening to ascertain whether animal welfare rules have been complied with and whether signs of any con-
dition which might adversely affect human or animal health are present. An official auxiliary may carry out
this screening.

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

(a)

(b)

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.

6. When ante-mortem inspection is not carried out at the holding, the official veterinarian is to carry out a flock

inspection at the slaughterhouse.

7.

8.

If the birds show clinical symptoms of a disease, they may not be slaughtered for human consumption. However,
killing of these birds on the slaughter line may take place at the end of the normal slaughter process, if precau-
tions are taken to avoid the risk of spreading pathogenic organisms and to clean and disinfect the facilities imme-
diately after killing.

In the case of poultry reared for the production of ‘foie gras’ and delayed eviscerated poultry slaughtered at the
holding of provenance, ante-mortem inspection is to be carried out in accordance with paragraphs 2 and 3. A
certificate conforming to the model set out in Part C is to accompany the uneviscerated carcases to the slaugh-
terhouse or cutting plant.

B.

POST-MORTEM INSPECTION

1. All birds are to undergo post-mortem inspection in accordance with Sections I and III. In addition, the official vet-

erinarian is personally to carry out the following checks:

(a)

daily inspection of the viscera and body cavities of a representative sample of birds;

(b)

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

(c)

any further investigations necessary when there is reason to suspect that the meat from the birds concerned
could be unfit for human consumption.

2.

In the case of poultry reared for the production of ‘foie gras’ and delayed eviscerated poultry obtained at the hold-
ing of provenance, post-mortem inspection is to include a check on the certificate accompanying the carcases.
When such carcases are transported directly from the holding to a cutting plant, post-mortem inspection is to take
place at the cutting plant.

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C.

SPECIMEN HEALTH CERTIFICATE

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CHAPTER VI: FARMED LAGOMORPHS

The requirements for poultry are to apply to farmed lagomorphs.

CHAPTER VII: FARMED GAME

A. Ante-mortem inspection

1. Ante-mortem inspection may be carried out at the holding of provenance when the requirements of Annex III,
Section III, to Regulation (EC) No 853/2004 are satisfied. In this case, an official veterinarian or an approved vet-
erinarian is to carry out ante-mortem inspection.

2. Ante-mortem inspection at the holding is to include checks on the records or documentation at the holding,

including food chain information.

3. When ante-mortem inspection takes place no more than three days before the arrival of the animals at the slaugh-
terhouse, and animals are delivered to the slaughterhouse live, ante-mortem inspection at the slaughterhouse need
only cover:

(a)

a control of the animals’ identification;

and

(b)

a screening to ascertain whether animal welfare rules have been complied with and whether signs of any con-
dition which might adversely affect human or animal health are present.

4. A certificate conforming to the specimen in Chapter X, Part A, is to accompany live animals inspected at the hold-
ing. A certificate conforming to the specimen in Chapter X, Part B, is to accompany animals inspected and slaugh-
tered at the holding.

B.

Post-mortem inspection

1.

2.

This inspection is to include palpation and, where judged necessary, incision of those parts of the animal which
have undergone any change or are suspect for any other reason.

Post-mortem inspection procedures described for bovine and ovine animals, domestic swine and poultry are to
be applied to the corresponding species of farmed game.

3. When the animals have been slaughtered at the holding, the official veterinarian at the slaughterhouse is to check

the certificate accompanying them.

CHAPTER VIII: WILD GAME

A.

Post-mortem inspection

1. Wild game is to be inspected as soon as possible after admission to the game handling establishment.

2.

The official veterinarian is to take account of the declaration or information that the trained person involved in
hunting the animal has provided in accordance with Regulation (EC) No 853/2004.

3. During post-mortem inspection, the official veterinarian is to carry out:

(a)

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

(i)

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 ani-
mal before killing,

(ii)

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 appropriate;

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(d) where there are serious grounds for suspecting the presence of residues or contaminants, an analysis by sam-
pling 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 sus-
pected 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, pathological changes in the liver or the spleen, inflammation of the intestines or the
umbilical region,

(iv)

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),

(v)

the presence of parasites,

(vi)

formation of a significant amount of gas in the gastro-intestinal tract with discolouring of the internal
organs (when these viscera are present),

(vii)

significant abnormalities of colour, consistency or odour of muscle tissue or organs,

(viii) aged open fractures,

(ix)

emaciation and/or general or localised oedema,

(x)

recent pleural or peritoneal adhesions,

and

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

4. Where the official veterinarian so requires, the vertebral column and the head are to be split lengthwise.

5.

In the case of small wild game not eviscerated immediately after killing, the official veterinarian is to 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 any of the characteristics listed in paragraph 3(e), the official veterinarian is to 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.

6.

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.

B. Decisions following controls

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.

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CHAPTER IX: SPECIFIC HAZARDS

A. Transmissible spongiform encephalopathies

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.

B. Cysticercosis

1.

The post-mortem inspection procedures described in Chapters I and IV are the minimum requirements for the
examination for cysticercosis in bovine animals over six weeks old and swine. In addition, specific serological tests
may be used. In the case of bovines over six weeks old, incision of the masseters at post-mortem inspection is not
compulsory when a specific serological test is used. The same applies when bovine animals over six weeks old
have been raised on a holding officially certified to be free of cysticercosis.

2. Meat infected with cysticercus is to be declared unfit for human consumption. However, when the animal is not
generally infected with cysticercus, the parts not infected may be declared fit for human consumption after hav-
ing undergone a cold treatment.

C.

Trichinosis

1.

Carcases of swine (domestic, farmed game and wild game), solipeds and other species susceptible to trichinosis
are to be examined for trichinosis in accordance with applicable Community legislation, unless that legislation pro-
vides otherwise.

2. Meat from animals infected with trichinae is to be declared unfit for human consumption.

D. Glanders

1. Where appropriate, solipeds are to be examined for glanders. Examination for glanders in solipeds is to include a
careful examination of mucous membranes from the trachea, larynx, nasal cavities and sinuses and their ramifi-
cations, after splitting the head in the median plane and excising the nasal septum.

2. Meat from horses in which glanders has been diagnosed are to be declared unfit for human consumption.

E.

Tuberculosis

1. When animals have reacted positively or inconclusively to tuberculin, or there are other grounds for suspecting
infection, they are to be slaughtered separately from other animals, taking precautions to avoid the risk of con-
tamination of other carcases, the slaughter line and staff present in the slaughterhouse.

2. All meat from animals in which post-mortem inspection has revealed localised tuberculous lesions in a number
of organs or a number of areas of the carcase is to be declared unfit for human consumption. However, when a
tuberculous lesion has been found in the lymph nodes of only one organ or part of the carcase, only the affected
organ or part of the carcase and the associated lymph nodes need be declared unfit for human consumption.

F.

Brucellosis

1. When animals have reacted positively or inconclusively to a brucellosis test, or there are other grounds for sus-
pecting infection, they are to be slaughtered separately from other animals, taking precautions to avoid the risk of
contamination of other carcases, the slaughter line and staff present in the slaughterhouse.

2. Meat from animals in which post-mortem inspection has revealed lesions indicating acute infection with brucel-
losis is to be declared unfit for human consumption. In the case of animals reacting positively or inconclusively to
a brucellosis test, the udder, genital tract and blood must be declared unfit for human consumption even if no
such lesion is found.

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CHAPTER X: SPECIMEN HEALTH CERTIFICATE

A.

SPECIMEN HEALTH CERTIFICATE FOR LIVE ANIMALS

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B.

SPECIMEN HEALTH CERTIFICATE FOR ANIMALS SLAUGHTERED AT THE HOLDING

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ANNEX II

LIVE BIVALVE MOLLUSCS

CHAPTER I: SCOPE

This Annex applies to live bivalve molluscs and, by analogy, to live echinoderms, live tunicates and live marine gastropods.

CHAPTER II: OFFICIAL CONTROLS CONCERNING LIVE BIVALVE MOLLUSCS FROM CLASSIFIED PRODUCTION AREAS

A.

CLASSIFICATION OF PRODUCTION AND RELAYING AREAS

1.

2.

3.

4.

5.

The competent authority must fix the location and boundaries of production and relaying areas that it classifies.
It may, where appropriate, do so in cooperation with the food business operator.

The competent authority must classify production areas from which it authorises the harvesting of live bivalve
molluscs as being of one of three categories according to the level of faecal contamination. It may, where appro-
priate, do so in cooperation with the food business operator.

The competent authority may classify as being of Class A areas from which live bivalve molluscs may be collected
for direct human consumption. Live bivalve molluscs taken from these areas must meet the health standards for
live bivalve molluscs laid down in Annex III, Section VII, Chapter V, of Regulation (EC) No 853/2004.

The competent authority may classify as being of Class B areas from which live bivalve molluscs may be collected,
but placed on the market for human consumption only after treatment in a purification centre or after relaying so
as to meet the health standards referred to in paragraph 3. Live bivalve molluscs from these areas must not exceed
the limits of a five-tube, three dilution Most Probable Number (MPN) test of 4 600 E.coli per 100 g of flesh and
intravalvular liquid.

The competent authority may classify as being of Class C areas from which live bivalve molluscs may be collected
but placed on the market only after relaying over a long period so as to meet the health standards referred to in
paragraph 3. Live bivalve molluscs from these areas must not exceed the limits of a five-tube, three dilution MPN
test of 46 000 E.coli per 100 g of flesh and intravalvular liquid.

6.

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

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

nation for the production area;

(b)

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.;

(c)

determine the characteristics of the circulation of pollutants by virtue of current patterns, bathymetry and
the tidal cycle in the production area;

and

(d)

establish a sampling programme of bivalve molluscs in the production area which is based on the examina-
tion 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.

B. MONITORING OF CLASSIFIED RELAYING AND PRODUCTION AREAS

1.

Classified relaying and production areas must be periodically monitored to check:

(a)

that there is no malpractice with regard to the origin, provenance and destination of live bivalve molluscs;

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(b)

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

(c)

for the presence of toxin-producing plankton in production and relaying waters and biotoxins in live bivalve
molluscs;

and

(d)

for the presence of chemical contaminants in live bivalve molluscs.

2.

To implement paragraph 1(b), (c) and (d), sampling plans must be drawn up providing for such checks to take
place at regular intervals, or on a case-by-case basis if harvesting periods are irregular. The geographical distribu-
tion of the sampling points and the sampling frequency must ensure that the results of the analysis are as repre-
sentative as possible for the area considered.

3.

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

(a)

the likely variation in faecal contamination,

and

(b)

the parameters referred to in paragraph 6 of Part A.

4.

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

(a)

periodic sampling to detect changes in the composition of plankton containing toxins and their geographi-
cal distribution. Results suggesting an accumulation of toxins in mollusc flesh must be followed by intensive
sampling;

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

5.

The sampling frequency for toxin analysis in the molluscs is, as a general rule, to be weekly during the periods at
which harvesting is allowed. This frequency may be reduced in specific areas, or for specific types of molluscs, if
a risk assessment on toxins or phytoplankton occurrence suggests a very low risk of toxic episodes. It is to be
increased where such an assessment suggests that weekly sampling would not be sufficient. The risk assessment
is to be periodically reviewed in order to assess the risk of toxins occurring in the live bivalve molluscs from
these areas.

6. When knowledge of toxin accumulation rates is available for a group of species growing in the same area, a spe-
cies with the highest rate may be used as an indicator species. This will allow the exploitation of all species in the
group if toxin levels in the indicator species are below the regulatory limits. When toxin levels in the indicator
species are above the regulatory limits, harvesting of the other species is only to be allowed if further analysis on
the other species shows toxin levels below the limits.

7. With regard to the monitoring of plankton, the samples are to be representative of the water column and to pro-
vide information on the presence of toxic species as well as on population trends. If any changes in toxic popu-
lations that may lead to toxin accumulation are detected, the sampling frequency of molluscs is to be increased or
precautionary closures of the areas are to be established until results of toxin analysis are obtained.

8.

Sampling plans to check for the presence of chemical contaminants must enable the detection of any overshoot-
ing of the levels laid down in Commission Regulation (EC) No 466/2001 (1).

C. DECISIONS AFTER MONITORING

1. Where the results of sampling show that the health standards for molluscs are exceeded, or that there may be oth-
erwise a risk to human health, the competent authority must close the production area concerned, preventing the

(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).

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harvesting of live bivalve molluscs. However, the competent authority may reclassify a production area as being
of Class B or C if it meets the relevant criteria set out in Part A and presents no other risk to human health.

2.

The competent authority may re-open a closed production area only if the health standards for molluscs once
again comply with Community legislation. If the competent authority closes a production because of the pres-
ence of plankton or excessive levels of toxins in molluscs, at least two consecutive results below the regulatory
limit separated at least 48 hours are necessary to re-open it. The competent authority may take account of infor-
mation on phytoplankton trends when taking this decision. When there are robust data on the dynamic of
the toxicity for a given area, and provided that recent data on decreasing trends of toxicity are available, the
competent authority may decide to re-open the area with results below the regulatory limit obtained from one
single sampling.

D. ADDITIONAL MONITORING REQUIREMENTS

1.

2.

The competent authority is to monitor classified production areas from which it has forbidden the harvesting of
bivalve molluscs or subjected harvesting to special conditions, to ensure that products harmful to human health
are not placed on the market.

In addition to the monitoring of relaying and production zones referred to in paragraph 1 of Part B, a control
system must be set up comprising laboratory tests to verify food business operators’ compliance with the require-
ments for the end product at all stages of production, processing and distribution. This control system is, in par-
ticular, 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.

E.

RECORDING AND EXCHANGE OF INFORMATION

The competent authority must:

(a)

(b)

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

(c)

act promptly where the controls prescribed in this Annex indicate that a production area must be closed or reclas-
sified or can be re-opened.

F.

FOOD BUSINESS OPERATORS’ OWN CHECKS

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 nec-
essary, 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.

CHAPTER III: OFFICIAL CONTROLS CONCERNING PECTINIDAE HARVESTED OUTSIDE CLASSIFIED PRODUCTION
AREAS

Official controls on pectinidae 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.

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ANNEX III

FISHERY PRODUCTS

CHAPTER I: OFFICIAL CONTROLS OF PRODUCTION AND PLACING ON THE MARKET

1. Official controls on the production and placing on the market of fishery products are to include, in particular:

(a)

a regular check on the hygiene conditions of landing and first sale;

(b)

inspections at regular intervals of vessels and establishments on land, including fish auctions and wholesale mar-
kets, to check, in particular:

(i) where appropriate, whether the conditions for approval are still fulfilled,

(ii) whether the fishery products are handled correctly,

(iii)

for compliance with hygiene and temperature requirements,

and

(iv)

the cleanliness of establishments, including vessels, and their facilities and equipment, and staff hygiene;

and

(c)

checks on storage and transport conditions.

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

(a) may be carried out when vessels call at a port in a Member State;

(b)

concern all vessels landing fishery products at ports in the Community, irrespective of flag;

and

(c) 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.

3.

(a)

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.

(b) When the competent authority of the Member State the flag of which the vessel is flying has granted the ves-
sel conditional approval in accordance with Article 3, that competent authority may authorise a competent
authority of:

(i)

another Member State,

or

(ii)

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.

4. When the competent authority of a Member State authorises the competent authority of another Member State or of
a third country to carry out inspections on its behalf in accordance with paragraph 3, the two competent authorities
are to agree on the conditions governing such inspections. These conditions are to ensure, in particular, that the com-
petent authority of the Member State the flag of which the vessel is flying receives reports on the results of inspections
and on any suspected non-compliance without delay, so as to enable it to take the necessary measures.

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CHAPTER II: OFFICIAL CONTROLS OF FISHERY PRODUCTS

Official controls of fishery products are to include at least the following elements.

A. ORGANOLEPTIC EXAMINATIONS

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.

B.

FRESHNESS INDICATORS

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.

C. HISTAMINE

Random testing for histamine is to be carried out to verify compliance with the permitted levels laid down under Com-
munity legislation.

D. RESIDUES AND CONTAMINANTS

Monitoring arrangements are to be set up to control the levels of residues and contaminants in accordance with Com-
munity legislation.

E. MICROBIOLOGICAL CHECKS

Where necessary, microbiological checks are to be performed in accordance with the relevant rules and criteria laid
down under Community legislation.

F.

PARASITES

Random testing is to take place to verify compliance with Community legislation on parasites.

G.

POISONOUS FISHERY PRODUCTS

Checks are to take place to ensure that the following fishery products are not placed on the market:

1.

poisonous fish of the following families are not placed on the market: Tetraodontidae, Molidae, Diodontidae and
Canthigasteridae;

and

2.

fishery products containing biotoxins such as Ciguatera or other toxins dangerous to human health. However, fish-
ery 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.

CHAPTER III: DECISIONS AFTER CONTROLS

Fishery products are to be declared unfit for human consumption if:

1.

2.

organoleptic, chemical, physical or microbiological checks or checks for parasites have shown that they are not in com-
pliance 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;

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3.

they derive from:

(i)

poisonous fish,

(ii)

fishery products not complying with the requirement of part G, point 2, of Chapter II concerning biotoxins,

or

(iii) 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

4.

the competent authority considers that they may constitute a risk to public or animal health or are for any other rea-
son not suitable for human consumption.

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ANNEX IV

RAW MILK AND DAIRY PRODUCTS

CHAPTER I: CONTROL OF MILK PRODUCTION HOLDINGS

1. Animals on milk production holdings must be subject to official controls to verify that the health requirements for raw
milk production, and in particular the health status of the animals and the use of veterinary medicinal products, are
being complied with.

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.

2.

If there are grounds for suspecting that the animal health requirements are not being complied with, the general health
status of the animals is to be checked.

3. Milk production holdings are to undergo official controls to verify that hygiene requirements are being complied with.
These official controls may involve inspections and/or the monitoring of controls that professional organisations carry
out. If it is shown that the hygiene is inadequate, the competent authority is to verify that appropriate steps are taken
to correct the situation.

CHAPTER II: CONTROL OF RAW MILK UPON COLLECTION

1.

2.

The competent authority is to monitor the checks carried out in accordance with Annex III, Section IX, Chapter I,
Part III, to Regulation (EC) No 853/2004.

If the food business operator has not corrected the situation within three months of first notifying the competent
authority of non-compliance with the criteria with regard to plate count and somatic cell count, delivery of raw milk
from the production holding is to be suspended or — in accordance with a specific authorisation of, or general instruc-
tions from, the competent authority — subjected to requirements concerning its treatment and use necessary to pro-
tect public health. This suspension or these requirements are to remain in place until the food business operator has
proved that the raw milk again complies with the criteria.

L 226/126

EN

Official Journal of the European Union

25.6.2004

ANNEX V

ESTABLISHMENTS NOT SUBJECT TO THE LISTING REQUIREMENT
OF ARTICLE 12(1)

The following third-country establishments need not appear on lists drawn up and updated in accordance with Article 12(4):

1.

2.

3.

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.

25.6.2004

EN

Official Journal of the European Union

L 226/127

ANNEX VI

REQUIREMENTS FOR CERTIFICATES ACCOMPANYING IMPORTS

1. The representative of the competent authority of the third country of dispatch issuing a certificate to accompany a con-
signment 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 fac-
tory vessels, the competent authority may authorise the captain or another ship’s officer to sign the certificate.

2. Certificates must be drawn up in the official language or languages of the third country of dispatch and the Member State
in which the border inspection takes place, or be accompanied by a certified translation into that language or languages.
If the Member State of destination so requests, certificates must also be accompanied by a certified translation into the
official language or languages of that Member State. However, a Member State may consent to the use of an official Com-
munity language other than its own.

3. The original version of the certificate must accompany consignments on entry into the Community.

4. Certificates must consist of:

(a)

a single sheet of paper;

or

(b)

two or more pages that are part of an integrated and indivisible sheet of paper;

or

(c)

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’).

5. Certificates must bear a unique identifying number. Where the certificate consists of a sequence of pages, each page must

indicate this number.

6. 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.