Common Position (EC) No 3/2004 of 27 October 2003 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a regulation of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption
Date: 2003-10-27
Institutions: Council of the European Union
Subjects: EC Regulation, animal product, common position, food inspection, foodstuffs legislation, human nutrition

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COMMON POSITION (EC) No 3/2004

adopted by the Council on 27 October 2003

with a view to the adoption of a Regulation (EC) No . . ./2004 of the European Parliament and of
the Council of . . . laying down specific rules for the organisation of official controls on products
of animal origin intended for human consumption

(2004/C 48 E/03)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

information available and it should therefore be possible
to adapt
them as relevant new information becomes
available.

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

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

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

After consulting the Committee of the Regions,

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

Whereas:

(1) Regulation (EC) No . . ./2004 of the European Parliament
and of the Council (4)
lays down general hygiene rules
foodstuffs and Regulation (EC) No
applying to all
. . ./2004 of
the
the European Parliament
Council (5) lays down specific hygiene rules for products
of animal origin.

and of

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

(3) The scope of the specific control rules should mirror the
scope of
the specific hygiene rules for food business
operators laid down in Regulation (EC) No . . ./2004 (5).
However, Member States should also carry out appropriate
official controls to enforce national rules established in
accordance with Article 1(4) of
that Regulation. They
may do so by extending the principles of this Regulation
to such national rules.

(4) 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

(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 (OJ C . . .),
Council Common Position of 27 October 2003 and Position of the
European Parliament of
(not yet published in the Official
Journal).

. . .

(4) Page 1 of this Official Journal.
(5) Page 23 of this Official Journal.

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

(6) 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
the processes carried out and the food
throughput of
business operator concerned.

(7)

It is appropriate to provide for the adaptation of certain
specific control rules, through the transparent procedure
provided for in Regulation (EC) No . . ./2004 (4) and Regu-
lation (EC) No . . ./2004 (5), to provide flexibility in order
to accommodate the specific needs of establishments
which use traditional methods, have a low throughput
to special
or are located in regions that are subject
geographical
should also
constraints. The procedure
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.

(8) Official controls on the production of meat are necessary
to verify that food business operators comply with hygiene
laid down in
rules and respect criteria and targets
Community legislation. These official controls
should
comprise audits of food business operators' activities and
inspections, including checks on food business operators'
own controls.

(9)

it is appropriate for
In view of their specific expertise,
official 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.

(10) Official controls on the production of live bivalve molluscs
and on fishery products are necessary to check for
compliance 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.

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(11) Official controls on the production of

raw milk are
necessary to check for compliance with criteria and
targets laid down in Community legislation. Such official
controls
target milk production
should in particular
holdings and raw milk upon collection.

(a)

‘official control’ means any form of control
competent authority performs
compliance with food law,
animal welfare rules;

the
the verification of
including animal health and

that

for

(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
authorities 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 conferred on the Commission (1),

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

This Regulation lays down specific rules for the organi-

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

It shall apply only in respect of activities and persons to

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

The performance of official controls pursuant

to this
3.
to food business
Regulation shall be without prejudice
operators' primary legal
responsibility for ensuring food
safety, as laid down in Regulation (EC) No 178/2002 of the
European Parliament and of the Council, of 28 January 2002
laying down the general principles and requirements of food
law, establishing the European Food Safety Authority, and
laying down procedures in matters of food safety (3), and any
civil or criminal liability arising from the breach of their obli-
gations.

Article 2

Definitions

For the purposes of this Regulation, the following defi-

1.
nitions shall apply:

(1) OJ L 184, 17.7.1999, p. 23.
(2) Page 23 of this Official Journal.
(3) OJ L 31, 1.2.2002, p. 1.

(b) ‘verification’ means checking, by examination and the
specified

evidence, whether

of

provision
requirements have been fulfilled;

objective

(c)

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

(d)

(e)

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

and whether

arrangements

planned

‘inspection’ means the examination of establishments, of
animals 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;

(f)

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

(g)

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

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

(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

2.
shall also apply as appropriate:

(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
the Council of 3 October
European Parliament and of
animal
concerning
2002 laying down health rules
by-products not intended for human consumption (4);

(4) 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).

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(c) Regulation (EC) No . . ./2004 (1), except for the definition of

‘competent authority’; and

(d) Regulation (EC) No . . ./2004 (2).

CHAPTER II

OFFICIAL CONTROLS IN RELATION TO COMMUNITY ESTAB-
LISHMENTS

Article 3

Approval of establishments

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 requirements
(EC) No . . ./2004 (1) and (EC) No
of Regulations
. . ./2004 (2) and other relevant requirements of
food
law.

(b) The

all

grant

competent

infrastructure

It shall grant

authority may

conditional
if it appears from the on-site visit that the
approval
and
the
establishment meets
equipment requirements.
full approval
only if it appears from a new on-site visit carried out
the granting of conditional
within three months of
the other
that
approval
requirements referred to in (a).
If clear progress has
been made but the establishment 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.

establishment meets

the

2.
In the case of factory and freezer vessels flying the flag of
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.

including those with conditional

The competent authority shall give each approved estab-
3.
lishment,
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.

approval,

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.

authority

and the food business operator is not able to provide
the
adequate guarantees regarding future production,
to
competent
procedures
shall
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.

initiate

(c) In the case of wholesale markets,

authority may withdraw or
respect of certain units or groups of units.

the competent
in

suspend approval

5.

Paragraphs 1, 2 and 3 shall apply both:

(a) to establishments that begin placing products of animal
origin 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
the
no requirement
competent
under
required
paragraph 1 shall take place as soon as possible.

for approval.
on-site

In the latter case,

authority's

visit

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

legislation immediately prior

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).

Article 4

Requirements
in respect of all
products of animal origin falling within the scope of this
Regulation

for official controls

The competent authority shall carry out official controls
compliance with the

1.
to verify food business operators'
requirements of:

(a) Regulation (EC) No . . ./2004 (1);

(b) Regulation (EC) No . . ./2004 (2); and

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

(b) If the competent authority identifies serious deficiencies
or has to stop production at an establishment repeatedly

The official controls referred to in paragraph 1 shall

2.
include:

(1) Page 1 of this Official Journal.
(2) Page 23 of this Official Journal.

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

critical control point (HACCP)-based procedures;

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(b) the official controls specified in Articles 5 to 8; and

market, an official veterinarian shall carry out the auditing
tasks referred to in paragraphs 3 and 4.

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

Audits of good hygiene practices shall verify that food
3.
business operators apply procedures continuously and properly
concerning at least:

(a) checks on food-chain information;

(b) the design and maintenance of premises and equipment;

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

7. When carrying out
authority shall take special care:

auditing tasks,

the

competent

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

(d) personal hygiene;

(b) to verify the food business operator's relevant records;

(e)

training in hygiene and in work procedures;

(f) pest control;

(g) water quality;

(h) temperature control; and

(i) controls on food entering and leaving the establishment

and any accompanying documentation.

4.
Audits of HACCP-based procedures shall verify that food
business operators apply such procedures continuously and
the
properly, having particular
procedures provide the guarantees specified in Section II of
Annex II to Regulation (EC) No . . ./2004 (1). They shall,
in
particular, determine whether the procedures guarantee,
to
the extent possible, that products of animal origin:

regard to ensuring that

(c)

to take samples for laboratory analysis whenever necessary;
and

(d) to document elements taken into account and the findings

of the audit.

8.
The nature and intensity of auditing tasks in respect of
individual 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

(a) comply with microbiological criteria laid down under

compliance with food law.

Community legislation;

(b) comply with

Community
contaminants and prohibited substances; and

legislation

on

residues,

Article 5

Fresh meat

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

When,
in accordance with Article 5 of Regulation (EC) No
. . ./2004 (2), 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.

5.
Verification of compliance with the requirements of
Regulation (EC) No . . ./2004 (1) concerning the application of
take place in all establishments
identification marks shall
approved in accordance with that Regulation,
in addition to
verification of compliance with other traceability requirements.

In the case of slaughterhouses, game handling estab-
6.
lishments and cutting plants placing fresh meat on the

(1) Page 23 of this Official Journal.
(2) Page 1 of this Official Journal.

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
particular as regards:

(a)

food chain information;

(b) ante-mortem inspection;

(c) animal welfare;

(d) post-mortem inspection;

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(e) specified risk material and other animal by-products;

(iii) report any deficiency to the official veterinarian.

and

(f)

laboratory testing.

2. The health marking of carcasses of domestic ungulates,
farmed game mammals other than lagomorphs, and large
wild game, as well as half-carcasses, quarters and cuts
produced by cutting half-carcasses into three wholesale
in slaughterhouses and game-
cuts, shall be carried out
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
official 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
the
requirements of this Regulation can be met.

involved shall be such that all

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,
lagomorphs, fattening pigs and fattening veal calves 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; and

the purpose of

For
‘fattening pigs’ and
this point,
‘fattening veal calves’ means animals reared as a group
under the same conditions since weaning.

Member States may extend this system to meat from
other types of animals if rules adopted in accordance
with the procedure referred to in Article 19(2) so
permit.

(b) Member States may also allow slaughterhouse staff to
carry out
in
accordance with Annex I, Section III, Chapter III, Part B.

sampling and testing tasks

specific

7. Member States shall ensure that official veterinarians and
official auxiliaries are qualified and undergo training in
accordance 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
tunicates and live marine gastropods undergo official controls
as described in Annex II.

live bivalve molluscs,

live echinoderms,

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(1)(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.

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Such action shall

2.
following measures:

include, where

appropriate,

the

Article 11

(a)

the imposition of sanitation procedures or any other
corrective 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;

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

(e)

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

(f)

suspension or withdrawal of

the
approval;

the

establishment's

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).

A third country shall appear on such lists only if a
2.
in that country has taken place and
Community control
demonstrates that
the competent authority provides appro-
priate guarantees as specified in paragraph 4. However, a
third
a
Community control having taken place there if:

on such lists without

country may

appear

(a) the risk determined in accordance with Article 18, point 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.

(g)

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

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

(h) any other measure that the competent authority deems

appropriate.

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

The competent authority shall provide the food business

3.
operator concerned, or a representative, with:

(a)

the legislation of the third country on:

(i) products of animal origin,

(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

To ensure the uniform application of
the principles and
conditions laid down in Article 11 of Regulation (EC) No
178/2002 the procedures laid down in this Chapter shall
apply.

(ii) the use of veterinary medicinal products,

including
their
their placing on the market and the

rules on their prohibition or authorisation,
distribution,
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
raw materials used for
the
preparing feedingstuffs and of the final product;

(b)

the organisation of the third countries' competent autho-
rities, 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)

(e)

the resources,
competent authorities;

including diagnostic facilities available to

existence

the
procedures and control systems based on priorities;

and operation of documented control

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(f) where applicable,
and procedures
relevant
diseases;

the situation regarding animal health
for notifying the Commission and
international bodies of outbreaks of animal

(g)

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

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:

(h)

(i)

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

equivalence

or

the hygiene
handling,
products of animal origin destined for the Community;

conditions of production, manufacture,
applied to

and dispatch actually

storage

(j)

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

(a) that

establishment,

together with any establishments
handling raw material of animal origin used in the manu-
the products of animal origin concerned,
facture of
complies with relevant Community
in
particular those of Regulation (EC) No . . ./2004 (1), 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;

requirements,

(b) an official

inspection service

third country
supervises the establishments and makes available to the
Commission, where necessary, all relevant information on
establishments furnishing raw materials; and

in that

(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 recommen-
dations addressed to them following a Community control;

(c)

real powers

to stop the establishments

it has
from
exporting to the Community in the event that the estab-
lishments fail to meet the requirements referred to under
(a).

(l)

the existence,
approved zoonoses control programme; and

implementation and communication of an

(m) the existence,

implementation and communication of an

approved residue control programme.

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
paragraph 1 are drawn up, kept up-to-date and communicated
to the Commission.

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
they have been dispatched from, and
Community only if
obtained or prepared in, establishments that appear on lists
drawn up and updated in accordance with this Article, except:

that a specified third country provides

(a) when, on a case-by-case basis, it is decided, in accordance
with the procedure referred to in Article 19(2), that the
guarantees
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

(b) in the cases specified in Annex V.

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
third countries concerned in accordance with para-
graph 3.

(b) If no Member State objects to the new or updated list
within 20 working days of
the Commission's notifi-
cation, 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 considers
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).

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 manu-
factured from meat obtained in slaughterhouses and cutting

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

5.
all lists to be available to the public.

(1) Page 23 of this Official Journal.

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Article 13

Live bivalve molluscs, echinoderms, tunicates and marine
gastropods

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

Notwithstanding Article 12(1)(b),

live bivalve molluscs,
1.
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.

Exemptions

from paragraph 1 may be granted in
4.
accordance 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.

The requirement of paragraph 1 shall not apply to
classified production areas.
to pectinidae shall

2.
pectinidae harvested outside
However, official controls with respect
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
control of
production zones.

classification and

(b) A Community inspection visit on-the-spot shall

take

place before such lists are drawn up unless:

(i) the risk determined in accordance with Article 18,

point 18 does not warrant it; and

(ii) it is determined, when deciding to add a particular
in accordance with
to a list
production area
paragraph 1, that other information indicates that
the competent authority provides
the necessary
guarantees.

4.
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 14

Documents

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 under Regu-
lation (EC) No . . ./2004 (1) and Regulation (EC) No
. . ./2004 (2) or provisions that are equivalent
to those
requirements; and

(b) any special

import conditions established in accordance

with Article 18, point 19.

Article 15

Special provisions for fishery products

1.
The procedures laid down in this Chapter do not apply to
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
vessel
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:

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

competent

authority

former

the

— 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
the
it continues to comply

has declared that
vessel
to ensure that
with Community requirements;

it will regularly inspect

(1) Page 1 of this Official Journal.
(2) Page 23 of this Official Journal.

or

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(ii) on the basis of a joint communication from the
competent authority of the third country the flag
of which the vessel
flying and from the
is
competent authority of a Member State, to which
authority has delegated
former
the
responsibility for
the vessel
concerned, on condition that:

inspection of

competent

the

19(2), provided that they do not affect the achievement of the
objectives of this Regulation.

3. Member States may, without compromising achievement
of the objectives of this Regulation, adopt, in accordance with
paragraphs
the
4 to 7,
requirements laid down in Annex I.

national measures

adapting

— 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
the
it continues to comply

has declared that
vessel
to ensure that
with Community requirements.

it will regularly inspect

(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.

4.

The national measures referred to in paragraph 3 shall:

(a) have the aim of:

(i) enabling the continued use of traditional methods at
stages of production, processing or

any of
the
distribution of food;

(ii) accommodating the needs of food businesses with a
low throughput or that are situated in regions that are
subject 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;

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.

(ii) the presence of

the competent authority in estab-

lishments.

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

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:

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

III,

Annexes I,

IV, V and VI may be amended or
1.
II,
supplemented 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

(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
relevant, by providing a summary of the hazard analysis
carried out and any measures to be taken to ensure that the
adaptation will not compromise the objectives of this Regu-
lation; and

(d) give any other relevant information.

6.
The other Member States shall have three months from
the 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,
to appropriate amendments. Where
appropriate, the Commission may propose general measures
in accordance with paragraphs 1 or 2 of this Article.

if necessary,

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A Member State may adopt national measures adapting

7.
the requirements of Annex I only:

9. the cold treatment to be applied to meat in relation to

cysticercosis and trichinosis;

(a)

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

10. conditions under which holdings and regions can be

certified as officially free of cysticercus or trichinae;

(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
a decision in
to propose
accordance with paragraph 6.

adoption of

the

State

adopts national measures
8. When a Member
implementing a pilot project to try out new approaches to
hygiene controls 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 proposing general measures in accordance
with paragraph 1.

Article 18

Specific decisions

implementing measures may be

Without prejudice to the generality of Article 16 and Article
laid down, or
17(1),
amendments to Annexes I,
in
II,
accordance with the procedure referred to in Article 19(2), to
specify:

IV, V or VI adopted,

III,

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 slaughter-
houses and game handling establishments throughout ante-
mortem and post-mortem inspection;

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 analytical
and the methods
tolerances 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
in third countries
third countries and establishments
available to the public pursuant to Articles 11, 12, 13
and 15;

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

documents;

4. rules concerning the content of tests for official veteri-

narians and official auxiliaries;

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

5. microbiological criteria for process control in relation to

hygiene in establishments;

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

if

7. 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
country of origin and to the principles of risk analysis;

8. rules for laboratory testing;

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
necessary, the results of Community controls carried out
in such third countries. These special
import conditions
may be 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; and

20. the conditions governing imports of products of animal
origin from a third country or a region of a third
country pursuant 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.

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Article 19

Committee procedure

1.
The Commission shall be assisted by the Standing
Committee 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
provisions 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.

3) before proposing implementing measures on the matters

referred to in Article 18, points 5 to 15.

Article 21

Report to the European Parliament and to the Council

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

The Commission shall,

2.
report with relevant proposals.

if appropriate, accompany the

Article 22

Entry into force

Article 20

Consultation of the European Food Safety Authority

the European Food Safety
The Commission shall consult
Authority on matters falling within the scope of this Regu-
lation whenever necessary and, in particular:

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

2) 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
brucellosis or tuberculosis; and

This Regulation shall enter into force twenty days after the date
of its publication in the Official Journal of the European Union.

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

(a) Regulation (EC) No . . ./2004 (1);

(b) Regulation (EC) No . . ./2004 (2), and

(c) Directive 2004/. . ./EC of the European Parliament and of
the Council of . . . repealing certain Directives concerning
food hygiene and health conditions for the production and
placing on the market of certain products of animal origin
intended for human consumption (3).

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 . . .

For the European Parliament

The President

For the Council

The President

(*) Five years after the entry into force of this Regulation.
(1) See page 1 of this Official Journal.
(2) See page 23 of this Official Journal.
(3) See page 131 of this Official Journal.

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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(3) concerning audits of good hygiene practices, the official
veterinarian 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(4) concerning audits of HACCP-based principles, the official

veterinarian 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

produced 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 provenance
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 accompanying
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 implementing
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 veterinarian 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.

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).

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3. 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.

4. 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 . . ./2004 (1).

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

laboratory 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 carcases 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 developments 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.

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.

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
veterinarian is to check the removal, separation and, where appropriate, marking of such products. The official
veterinarian is to ensure that the food business operator takes all necessary measures to avoid contaminating meat
with specified risk material during slaughter (including stunning) and removal of specified risk material.

(1) Page 23 of this Official Journal.

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F. LABORATORY TESTING

1. The official veterinarian is to ensure that sampling takes place and that samples are appropriately identified and

handled and sent to the appropriate laboratory within the framework of:

(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

perfectly 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;

(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.

4. 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.

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

colouring substances in foodstuffs.

6. 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.

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 provided for in Annex II, Section I, to Regulation (EC) No . . ./2004 (3).

(1) OJ L 147, 31.5.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 1234/2003 (OJ L 173, 11.7.2003, p. 6).
(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).
(3) Page 23 of this Official Journal.

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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

compromise 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 veterin-
arian 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 legis-
lation.

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

provided 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.

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

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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 provenance 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 under Regulation (EC) No
. . ./2004 (1) to ensure that animals accepted for slaughter for human consumption are properly identified. The
official 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
. . ./2004 (1) 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 addition, 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
with Community legislation, or residues of forbidden substances, are to be dealt with in accordance with Directive
96/23/EC.

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 salmonella, 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
issuing directions to slowing down and stopping production, depending on the nature and gravity of the problem.

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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 . . ./2004 (1);

(c) derives from animals which are dead before slaughter, stillborn, unborn or slaughtered under the age of 7 days;

(d)

results from the trimming of sticking points;

(e) derives from animals affected by an OIE List A or, where appropriate, OIE List B disease, unless otherwise

provided for in Section IV;

(f)

(g)

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

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

(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;

(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 metals 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;

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(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.

in relation to auditing tasks, official auxiliaries may only collect information regarding good hygienic practices and
HACCP-based procedures;

2.

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

3.

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.

2. However, the competent authority may adapt this approach in certain slaughterhouses and game handling estab-
lishments 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.

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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
animals susceptible to the particular disease in question that come from the particular region as defined in Article
2 of Council Directive 64/432/EEC (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.

CHAPTER III: INVOLVEMENT OF SLAUGHTERHOUSE STAFF

A. SPECIFIC TASKS CONCERNING THE PRODUCTION OF MEAT FROM POULTRY, LAGOMORPHS, FATTENING

PIGS AND FATTENING VEAL CALVES

1. (a) The competent authority may, in accordance with paragraph 2, authorise designated slaughterhouse staff to carry

out specific tasks in connection with official controls. These tasks may concern:

(i) in slaughterhouses for poultry and/or lagomorphs: poultry, lagomorphs and other animals slaughtered in the

same slaughterhouse; and

(ii) in slaughterhouses for domestic ungulates: fattening pigs and fattening veal calves.

(b) These specific tasks may consist only of tasks that official auxiliaries are authorised to carry out in accordance

with Chapter I, with the exception of auditing tasks.

(c) To receive the authorisation referred to in (a), the slaughterhouse must have been operating in full compliance
with hygiene requirements, particularly good hygienic practices and HACCP-based procedures, for at least 12
months.

(d) The designated slaughterhouse staff may only carry out specific tasks if they have received appropriate training
and passed an appropriate test, and if the official veterinarian supervises these tasks. Training and tests are to be
at least equivalent to those required for official auxiliaries in respect of the specific tasks carried out.

(e) The official veterinarian must be present throughout ante-mortem and post-mortem inspection and carry out regular
performance tests to ascertain that
the designated slaughterhouse staff meets specific
parameters that the competent authority has set. The official veterinarian is to document the results of these
performance tests.

the performance of

(f)

If:

(i) the overall level of hygiene in the slaughterhouse decreases because of the manner in which the designated

slaughterhouse staff carry out their tasks,

(ii) the designated slaughterhouse staff do not carry out their tasks properly, or

(iii) the designated slaughterhouse staff carry out their tasks in a manner that the competent authority considers

unsatisfactory,

(1) OJ 121, 29.7.1964, p. 1977/64. Directive as last amended by Commission Regulation (EC) No 1226/2002 (OJ L 179, 9.7.2002,

p. 13).

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the competent authority is to slow down or to stop production for the time necessary for the slaughterhouse
operator to take necessary measures to correct the situation or, if appropriate, for the time necessary for it to
arrange for its staff to carry out the tasks in place of designated slaughterhouse staff. If the slaughterhouse
operator fails to take appropriate corrective measures, the competent authority may withdraw the authorisation
referred to in (a).

2. The competent authority is to decide in principle and on a case-by-case basis whether to permit the implementation
of the system described in paragraph 1 in a given slaughterhouse. Before reaching this decision, the competent
authority must analyse:

(a) production and inspection records;

(b) the type of activities undertaken in the slaughterhouse;

(c) the history of compliance with legal requirements;

(d) the expertise, professional attitude and sense of responsibility as regards food safety of the slaughterhouse staff
concerned and whether there is an appropriate degree of separation of responsibilities for production and
inspection; and

(e) other relevant information.

3. If the competent authority decides in principle to permit the implementation of the system described in paragraph 1,
it must inform the Commission of its decision and any requirements that it decides to impose in addition to those
required under paragraph 1.

4. The competent authority may not force food business operators to introduce the system described in paragraph 1.

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. The competent authority may appoint only veterinarians who have passed a test meeting the requirements of

paragraph 2 as official veterinarians.

2. The competent authority must make arrangements for the test. The test is to confirm knowledge of the following

subjects to the extent necessary depending on the veterinarian's background and qualifications:

(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 (including

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

(c)

essentials of food processing and food technology;

(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;

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(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
continuing education resulting in a post-graduate qualification, it may waive the requirement for a test.

3. The veterinarian is to have aptitude for multidisciplinary cooperation.

4. 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.

5. 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.

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.

B. OFFICIAL AUXILIARIES

1. The competent authority may appoint as official auxiliaries only persons who have undergone training and passed a

test in accordance with the following requirements.

2. 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 specified

in paragraph 5; and

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

3. 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.

4. Training and tests are to concern principally red meat or poultry meat. 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.

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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,

— 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, packaging

and transport of fresh meat,

— basic knowledge of microbiology,

— ante-mortem inspection,

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— 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,

— post-mortem inspection in a slaughterhouse,

— examination for trichinosis,

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

— identifying and commenting on parts of slaughtered animals in which changes have occurred,

— hygiene control, including the audit of the good hygiene practices and the HACCP-based procedures,

— recording the results of ante-mortem inspection,

— sampling,

— traceability of meat,

— documentation.

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

7. Persons already appointed as official auxiliaries must have adequate knowledge of the subjects mentioned in
paragraph 5. Where necessary, they are to acquire this knowledge through continuing education activities. The
competent 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

trichinosis, 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. visual

inspection of the head and throat;

incision and examination of the retropharyngeal

lymph nodes (Lnn

retropharyngiales); inspection of the mouth and fauces; palpation of the tongue; removal of the tonsils;

2. visual inspection of the lungs, trachea and oesophagus; palpation of the lungs; incision and examination of the
bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main
branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third,
perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human
consumption;

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

incision of the liver and its lymph nodes;

6. 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;

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. 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;

2.

inspection of the trachea and oesophagus; visual examination and palpation of the lungs; incision and examination
of the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the
main branches of the bronchi must be opened lengthways and the lungs must be incised in their posterior third,
perpendicular to their main axes; these incisions are not necessary where the lungs are excluded from human
consumption;

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. 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;

6. 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;

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 lactiferes)
and the lymph nodes of the udder must be incised, except when the udder is excluded from human consumption.

CHAPTER II: DOMESTIC SHEEP AND GOATS

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

1. visual inspection of the head after flaying and, in the event of doubt, examination of the throat, mouth, tongue and
retropharyngeal and parotid lymph nodes. Without prejudice to animal-health rules, these examinations are not
necessary if the competent authority is able to guarantee that the head, including the tongue and the brains, will be
excluded from human consumption;

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2. 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. 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;

6. 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

umbilical 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. 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;

2. visual inspection of the lungs, trachea and oesophagus; palpation of the lungs; palpation and, if necessary, incision
of the bronchial and mediastinal lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the
main branches of the bronchi must be opened lengthwise and the lungs must be incised in their posterior third,
perpendicular to their main axes; however, these incisions are not necessary where the lungs are excluded from
human consumption;

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. visual inspection, palpation and, if necessary, incision of the liver and the hepatic and pancreatic lymph nodes, (Lnn

portales);

6. 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;

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 supra-

mammary lymph nodes;

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

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

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
shoulder. The kidneys must be exposed and examined by incision through the entire kidney.

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CHAPTER IV: DOMESTIC SWINE

A. ANTE-MORTEM INSPECTION

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

(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
condition 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;

(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) visual

inspection of the head and throat;

incision and examination of the submaxillary lymph nodes (Lnn

mandibulares); visual inspection of the mouth, fauces and tongue;

(b) visual inspection of the lungs, trachea and oesophagus; palpation of the lungs and the bronchial and mediastinal
lymph nodes (Lnn. bifucationes, eparteriales and mediastinales). The trachea and the main branches of the bronchi
must be opened lengthwise and the lungs must be incised in their posterior third, perpendicular to their main
axes; these incisions are not necessary where the lungs are excluded from human consumption;

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

cut through the interventricular septum;

(d) visual inspection of the diaphragm;

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

its lymph nodes;

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(f) visual

inspection of the gastro-intestinal tract, the mesentery, the gastric and mesenteric lymph nodes (Lnn.
incision of the gastric and mesenteric

if necessary,

gastrici, mesenterici, craniales and caudales); palpation and,
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 fattening
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 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 on the holding of provenance is to comprise:

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

(b) a flock inspection, to determine whether the birds:

(i) have a disease or condition which may be transmitted to animals or humans through handling or eating the

meat, or are behaving in a manner indicating that such a disease may occur,

(ii) 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
condition 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)

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;

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(b) 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. 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 precautions
are taken to avoid the risk of spreading pathogenic organisms and to clean and disinfect the facilities immediately
after killing.

8. 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 carcasses to the
slaughterhouse 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

veterinarian 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 holding
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 . . ./2004 (1) are satisfied. In this case, an official veterinarian or an approved veterinarian 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 slaughter-
house, 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

condition 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 holding.
A certificate conforming to the specimen in Chapter X, Part B, is to accompany animals inspected and slaughtered at
the holding.

B. POST-MORTEM INSPECTION

1. 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.

2. 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 . . ./2004 (1).

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 animal
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 sampling
of residues not resulting from the hunting process,
including environmental contaminants. When a more
extensive inspection is made on the basis of such suspicions, the veterinarian must wait until that inspection
has been concluded before assessing all the game killed during a specific hunt, or those parts suspected of
showing the same abnormalities;

(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 are to be declared unfit for human consumption.

CHAPTER IX: SPECIFIC HAZARDS

A. TRANMISSIBLE 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 6 weeks old and swine. In addition, specific serological tests
may be used. In the case of bovines over 6 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 6 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 having
undergone a cold treatment.

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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 provides
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 contami-
nation 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 suspecting
infection, they are to be slaughtered separately from other animals, taking precautions to avoid the risk of contami-
nation 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 brucellosis 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,
gastropods.

live tunicates and live marine

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

A. CLASSIFICATION OF PRODUCTION AND RELAYING AREAS

1. 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.

2. 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.

3. The competent authority may classify as being of Class A areas from which live bivalve molluscs may be collected for
direct human consumption. Live bivalve molluscs 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 . . ./2004 (1).

4. 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.

5. 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 contamination

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 examination of
established data, and with a number of samples, a geographical distribution of the sampling points and a
sampling frequency which must ensure that the results of the analysis are as representative as possible for the
area considered.

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 distribution of the
sampling points and the sampling frequency must ensure that the results of the analysis are as representative 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 geographical
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 species
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 provide
information on the presence of toxic species as well as on population trends. If any changes in toxic populations 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 overshooting 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
otherwise a risk to human health, the competent authority must close the production area concerned, preventing the
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.

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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 presence of
plankton or excessive levels of toxins in molluscs, at least two consecutive results below the regulatory limit
separated by at least 48 hours are necessary to re-open it. The competent authority may take account of information
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. 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.

2. 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 requirements for
the end product at all stages of production, processing and distribution. This control system is, in particular, to verify
that the levels of marine biotoxins and contaminants do not exceed safety limits and that the microbiological quality
of the molluscs does not constitute a hazard to human health.

E. RECORDING AND EXCHANGE OF INFORMATION

The competent authority must:

(a) establish and keep up to date a list of approved production and relaying areas, with details of their location and
boundaries, as well as the class in which the area is classified, from which live bivalve molluscs may be taken in
accordance with the requirements of this 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;

(b) 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

reclassified 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
necessary, sampling and analysis must have taken place in accordance with a protocol that the competent authority
and the food business operators or organisation concerned have agreed.

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 . . ./2004 (1)
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

markets, 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 vessel
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
competent 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
Community legislation.

D. RESIDUES AND CONTAMINANTS

Monitoring arrangements are to be set up to control the levels of residues and contaminants in accordance with
Community 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, fishery
products derived from bivalve molluscs, echinoderms, tunicates and marine gastropods may be placed on the market
if they have been produced in accordance with Section VII of Annex III to Regulation (EC) No . . ./2004 (1) and
comply with the standards laid down in Chapter V, point 2, of that Section.

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CHAPTER III: DECISIONS AFTER CONTROLS

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

1. organoleptic, chemical, physical or microbiological checks or checks for parasites have shown that they are not in

compliance with the relevant Community legislation;

2. 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;

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 . . ./2004 (1); or

4. the competent authority considers that they may constitute a risk to public or animal health or are for any other

reason not suitable for human consumption.

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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 organi-
sations 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. 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 . . ./2004 (1).

2. 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
instructions from, the competent authority — subjected to requirements concerning its treatment and use necessary
to protect 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.

(1) See page 23 of this Official Journal.

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

ANNEX V

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

1. establishments handling products of animal origin for which Annex III to Regulation (EC) No . . ./2004 (1) does not

lay down requirements;

2. establishments carrying out only primary production;

3. establishments carrying out only transport operations;

4. establishments carrying out only the storage of products of animal origin not requiring temperature-controlled

storage conditions.

(1) See page 23 of this Official Journal.

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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
consignment of products of animal origin destined for the Community must sign the certificate and ensure that it
bears an official stamp. This requirement applies to each sheet of the certificate if it consists of more than one. In the
case of factory vessels, the competent authority may authorise the captain or another ship's officer to sign the
certificate.

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 Community 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 4 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.

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

In July 2002, the Commission proposed a Regulation of the European Parliament and of the Council
laying down specific rules for the organisation of official controls on products of animal origin
intended for human consumption.

The European Parliament adopted an opinion on the proposed Regulation in June 2003.

The Economic and Social Committee adopted an opinion in February 2003 (1).

After considering these opinions, the Council adopted a common position on 27 October 2003.

II. OBJECTIVE

The proposed Regulation is the third element of a package of five proposals with the aim of consoli-
dating, updating and simplifying Community legislation on food hygiene while ensuring a high level of
protection of public health. The Council simultaneously adopted common positions on all of the four
proposals subject to the co-decision procedure (2).

The Regulation would lay down specific rules for official controls on products of animal origin. In
particular, it would:

— provide for audits of food business operators'

implementation of good hygienic practices and

HACCP-based procedures;

— lay down specific requirements for official controls in respect of fresh meat, live bivalve molluscs,

fishery products and raw milk; and

— establish procedures governing the importation of products of animal origin.

III. ANALYSIS OF THE COMMON POSITION

A. Generalities

The common position incorporates several changes compared to the Commission's original
proposal. Several of
the
European Parliament proposed in its first-reading opinion. The Commission has accepted the
changes to its proposal.

these changes are consistent with the aims of amendments that

In addition to the more substantive modifications described below, the common position contains a
number of editorial changes, in particular:

— to ensure the overall coherence of the hygiene package (3);

— to ensure the internal coherence of the Regulation and its clarity, in particular by moving key

principles from the Annexes to the Articles (4); and

— to clarify the text (5).

It also contains a number of technical amendments consistent with the overall objectives of the
Regulation stated in Section II above (6).

(1) The Committee of the Regions decided not to provide an opinion.
(2) In December 2002, the Council adopted Directive 2002/99/EC laying down animal health rules governing the
production, processing, distribution and introduction of products of animal origin for human consumption, on
the basis of the Commission's fourth proposal.

(3) These include a change consistent with the aim of EP amendment 79.
(4) These include changes consistent with the aims of EP amendments 1, 3, 20, 21, 78, 115 and 117.
(5) These include changes consistent with the aims of EP amendments 5, 7 to 9, 13, 16 to 18, 22 to 24, 26, 39 to 45,

53, 54, 58 to 60, 66, 74, 84, 89, 104, 108, 110 to 113 and 124.

(6) These include changes consistent with the aims of EP amendments 52, 61, 82, 91 to 98 and 134.

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B. Regulation on official food and feed controls

The Commission's original proposal contained a number of references to the Regulation on official
food and feed controls, which would establish general rules for official controls on all types of food
and on feed (1).

However, it appears likely that adoption of the new food hygiene legislation will take place some
time before that of the Regulation on official food and feed controls. The common position
therefore contains no reference to that Regulation. Instead, it incorporates some of its provisions,
particularly as regards definitions (Article 2) and enforcement action (Article 9) (2).

C. Scope (Article 1)

There are close links between the second and third Regulations in the hygiene package. The second
Regulation would lay down specific hygiene rules for products of animal origin. The third Regu-
lation provides for official controls on such products.

The Council agrees that both Regulations ought to have the same scope. The common position is
therefore consistent with the aim of the European Parliament amendments that seek to import into
the third Regulation the scope and exemptions provided for in the second (3).

The common position also clarifies that the performance of official controls in no way diminishes
food business operators' responsibility for ensuring food safety.

D. Definitions (Article 2)

For the reasons given under B above, the common position incorporates four definitions from the
proposed Regulation on official food and feed controls (4).

In addition it:

— would preserve the definition of

‘competent authority’ used in several existing veterinary

Directives;

— provides for a definition of an ‘approved veterinarian’ to cover private veterinarians carrying out

specific official controls on holdings;

— clarifies that, while ‘official auxiliaries’ must be appointed by the competent authority, they need

not be ‘officers’ (civil servants) (5);

— provides for
1774/2002.

the incorporation of certain definitions laid down in Regulation (EC) No

E. Approval of establishments (Article 3)

Compared to the Commission's original proposal, the common position:

— provides some additional flexibility as regards conditional approval, particularly for factory and

freezer vessels;

(1) The Commission adopted a proposal for such a Regulation in February 2003 (COM(2003) 52 final — interinsti-

tutional file 2003/0030 COD).

(2) Article 9 is partly consistent with EP amendment 25.
(3) Amendments 11 and 12.
(4) The definitions of ‘official control’, ‘verification’, ‘audit’ and ‘inspection’.
(5) This definition is consistent with the aim of EP amendment 14.

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— contains clarification concerning existing establishments and wholesale markets;

— incorporates and generalises provisions on enforcement that initially appeared in Annex I; and

— provides for Member States to make lists of approved establishments available to the public (1).

F. Audits (Article 4)

The Commission's origin proposal provided for audits in respect of fresh meat.

The common position establishes audits as a general principle for all food business operators
handling products of animal origin falling within the scope of the Regulation. In view of their
specific expertise,
it would require official veterinarians to carry out audits of slaughterhouses,
game-handling establishments and certain cutting plants. It would give Member States discretion
to choose the most appropriate staff for audits of other establishments.

G. Official controls in respect of fresh meat (Article 5)

The Council agrees that the key principles applying to official controls in respect of fresh meat
ought to appear in an Article.

It also agrees that Member States should follow a risk-based approach to assess the number of
official staff that need to be present on the slaughter line in any particular slaughterhouse, but does
not believe that it would be appropriate to extend this assessment to cover the food business
operator's staff.

It further agrees that there need to be strict and clear rules determining when slaughterhouse staff
may assist with official controls. In particular, when carrying out certain specific tasks related to
official controls, such staff must always work under the supervision of the official veterinarian and
act independently from production staff.

However, the Council does not believe that it is appropriate to place unnecessary restrictions on the
scope of the procedure. The common position would initially give Member States the choice of
allowing slaughterhouse staff to assist with official controls on animals reared as a group under the
fattening pigs and fattening veal). The system could
same conditions (poultry,
subsequently be extended through comitology to other
in the light of
types of animals
experience (2).

lagomorphs,

H. Imports (Articles 10-15)

The Council agrees that it is more appropriate for procedural rules concerning imports to appear in
the Regulation dealing with official controls (3). It also believes that the rules must have the aim of
ensuring that trade between the Community and third countries respects the principle of equiv-
alence, while not imposing unnecessary or impracticable burdens on the parties involved.

The common position would therefore:

— establish the general rule that no third country may appear on a list of third countries from
which imports are permitted unless a Community control has taken place in that third country,
while providing flexibility for cases where such a control would provide no added value;

(1) This provision is consistent with the aim of EP amendment 19.
(2) Article 5 is therefore consistent with parts of EP amendments 21, 83 and 87.
(3) Articles 10 to 15 are therefore consistent with the aim of parts of EP amendments 26 to 29, 32, 34 and 35.

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— limit the requirement for third country establishments to appear on lists drawn up and updated
through a Community procedure to those establishments that are a priority for enforcement
action, while not affecting the basic requirement for all establishments involved in the manu-
facture of products of animal origin destined for export to the Community to comply with
Community food law or equivalent rules;

— make special provisions for vessels to reflect the fact that they may operate far from the
territory of the third country the flag of which they are flying and that the administrative
arrangements applying to establishments on land might not be applicable to vessels.

Since most of the provisions concerning imports are points of principle, they appear in Articles. In
addition, new Annexes V and VI list certain technical details, so that these might be amended
through comitology if necessary.

I. Flexibility and comitology (Articles 16-18)

The Council agrees that the Regulation should,
like the other hygiene Regulations, contain a
procedure enabling Member States to adopt national provisions adapting certain technical
provisions in a transparent manner. It believes, however, that this flexibility should only apply
to Annex I, since Annexes II to VI contain rules that should remain of general application. In the
context of official controls, it is also appropriate to provide for the use of the flexibility procedure
to enable pilot projects to take place to try out new approaches to hygiene controls on meat (1).

The Council also agrees that it should be possible to lay down transitional arrangements through
comitology in addition to amendments to the Annexes and implementing measures (2). In addition,
it believes that it should be possible to grant exemptions through the same procedure.

In the interest of clarity, the common position lists in a single Article a number of specific
decisions that could be taken through comitology (3).

J. Date of application (Article 22)

The Council considers that the scale of the reform of food hygiene legislation requires there to be a
reasonable delay between adoption of the new rules and their application. It is also necessary to
ensure that all elements of the hygiene package take effect at the same time.

The common position therefore provides for the Regulation to apply eighteen months after the date
on which all elements of the package are in force, but not before 1 January 2006.

K. Detailed rules for fresh meat (Annex I)

The common position incorporates a number of changes to the detailed requirements for official
controls with respect to fresh meat. In particular, these rules:

— no longer contain provisions that appear in the common position on the second Regulation

(laying down specific hygiene rules for products of animal origin);

— place greater emphasis on controls on meat from animals that have undergone emergency

slaughter (4);

(1) Article 17 is therefore partly consistent with EP amendment 138.
(2) Articles 16 and 17 are therefore consistent with EP amendments 38, 130 and 131.
(3) Article 18 is consistent with the aim of parts of EP amendments 56, 87, 116, 118, 120, 121 and 131.
(4) Annex I is therefore consistent with the aim of EP amendment 57.

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— limit the scope of health marking to carcasses and part-carcasses of red meat to reflect the

special role that the official veterinarian plays in such cases;

— clarify the circumstances in which meat is to be declared unfit for human consumption,

including meat with a pronounced sexual odour and blood (1);

— establish a short list of official controls that only official veterinarians may carry out, rather than

a long list of tasks with which official auxiliaries may assist.

There would be some flexibility as regards official veterinarians' presence at slaughterhouses and
game-handling establishments. The presence of at least one official veterinarian throughout ante-
mortem and post-mortem inspection would remain the basic requirement, but competent auth-
orities could adapt it on the basis of a risk assessment and under strict conditions ensuring that
proper inspection takes place (2).

With respect to training, the common position would enable competent authorities to appoint
official veterinarians without testing them, if the candidate has acquired all the required knowledge
as part of a university degree, or through continuing education resulting in a post-graduate qualifi-
cation. However, the Council does not believe that it would be appropriate in other circumstances
for competent authorities to appoint practising veterinarians as official veterinarians without testing
them (3).

The common position also slightly alters the division between theoretical and practical training for
official auxiliaries, without changing the overall requirement for 900 hours of training. It no longer
includes a provision providing for an increase in the number of hours by a given date, since this
was a political objective rather than a legal requirement. However, the Commission has undertaken,
when preparing its report on the experience gained from the implementation of the Regulation, to
consider whether it would be opportune to increase the minimum training requirements for official
auxiliaries (4).

L. Detailed rules for live bivalve molluscs (Annex II)

The Council believes that the sampling frequency for toxin analysis in live bivalve molluscs should
as a general rule be weekly during harvesting periods. It agrees, however, that there should be
flexibility to increase or to decrease the frequency in the light of a risk assessment (5).

The common position contains modernised criteria for the classification of production and
relaying areas. The criteria for areas of classes B and C now refer only to E.coli, since there is
agreement that faecal coliforms are not a reliable indicator of faecal contamination. It would be
possible to amend these criteria and to specify sampling plans, methods and analytical tolerances
through comitology (6).

M. Detailed rules for fishery products (Annex III)

The common position contains clarification concerning official controls on the production and
placing on the market of fishery products. In particular, it includes detailed rules concerning official
controls of vessels, to clarify which controls are necessary and which are possible taking account of
the practical and legal specificities.

(1) Annex I is therefore broadly consistent with the aim of EP amendments 132 and 133.
(2) Annex I is therefore consistent with part of EP amendment 85.
(3) Annex I is therefore consistent with part of EP amendment 88.
(4) This commitment is consistent with the aim of EP amendment 99.
(5) Annex II is therefore consistent with part of EP amendment 122.
(6) Articles 18(13)(c) and 20(3).

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N. Detailed rules for raw milk (Annex IV)

The common position contains only those requirements that are specific to official controls on the
production and collection of raw milk. It no longer includes rules that would have duplicated
general requirements applicable to all products of animal origin.

O. Other

To be consistent with other parts of the hygiene package, the common position would require the
Commission:

— to consult EFSA when necessary (Article 20); and

— to report on the implementation of the Regulation after five years (Article 21).

The common position does not reflect those of the Parliament's amendments that the Commission
was not able to accept, in particular those that:

— would extend health marking to meat from poultry and lagomorphs (1);

— deal with food business operators' responsibilities (2);

— would place undue restrictions on the scope for slaughterhouse staff to assist with official

controls (3);

— would eliminate the possibility of visual post-mortem inspection of certain categories of

fattening pigs (4);

— anticipate the outcome of discussions that should take place in the context of negotiations on

the proposed Regulation on official food and feed controls (5); or

— would introduce specific provisions for small artisanal businesses, rather than flexibility on the

basis of a risk assessment (6).

In addition, the Council and the Commission cannot accept amendments that would unnecessarily
tighten (7), weaken (8), or complicate (9) the new hygiene legislation or that are not consistent with its
scope or with other provisions (10).

IV. CONCLUSION

The Council is pleased to note that the Commission accepts its common position and that the draft
Regulation is consistent with the aim of several of the amendments that the European Parliament
adopted at first reading. It hopes that this will permit the rapid adoption of the Regulation and of the
remainder of the hygiene package.

(1) Amendments 62 to 64.
(2) Amendments 65 and 129.
(3) Amendments 81, 100, 127, 135, 136, 139 and 140.
(4) Amendment 109.
(5) Amendments 4, 69, 70, 76 and 77.
(6) Amendments 15 and 90.
(7) Amendments 2, 30, 33, 55, 67, 68, 75, 105, 106, 119 and 128.
(8) Amendments 46, 73, 101 to 103, 107 and 123.
(9) Amendments 6, 10, 31, 36, 37, 71, 72, 125 and 126.
(10) Amendments 80, 114 and 137.