Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption
Date: 2004-04-29
Institutions: Council of the European Union, European Parliament
Subjects: animal product, food inspection, food safety, health control, human nutrition, import (EU)

30.4.2004 

EN 

Official Journal of the European Union 

L 155/206 

REGULATION (EC) No  854/2004 OF THE EUROPEAN PARLIAMENT 

AND OF THE COUNCIL 

of 29 April 2004 

laying down specific rules for the organisation of official controls 

on products of animal origin intended for human consumption 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European 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, 

Having consulted the Committee of the Regions, 

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

1 
2 
3 

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

 
 
 
 
 
 
 
 
 
                                                 
 
Whereas: 

(1)  Regulation (EC) No .../2004 of the European Parliament and of the Council 1 lays down 

general hygiene rules applying to all foodstuffs and Regulation (EC) No …/2004 of the 
European Parliament and of the Council 2 lays down specific hygiene rules for products of 

animal origin. 

(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 *.  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 information available and it should therefore be 

possible to adapt them as relevant new information becomes available. 

(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. 

1 
2 
* 

Page … of this Official Journal. 
Page … of this Official Journal. 
Note for the Official Journal: insert number of Regulation laying down specific hygiene rules 
for food of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
                                                 
 
(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 throughput of the 

processes carried out and the food 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 * and Regulation (EC) 
No …/2004 **, to provide flexibility in order to accommodate the specific needs of 

establishments which use traditional methods, have a low throughput or are located in regions 

that are subject to special geographical constraints.  The procedure should also allow pilot 

projects to take place in order to try out new approaches to hygiene controls on meat.  

However, such flexibility should not compromise food hygiene objectives. 

(8)  Official controls on the production of meat are necessary to verify that food business 

operators comply with hygiene rules and respect criteria and targets laid down in Community 

legislation.  These official controls should comprise audits of food business operators' 

activities and inspections, including checks on food business operators' own controls. 

(9) 

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

*  

Note for the Official Journal: insert number of Regulation on the hygiene of foodstuffs 
(see recital 1, 1st Regulation). 

**   Note for the Official Journal: insert number of Regulation laying down specific hygiene rules 

for food of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
                                                 
 
(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. 

(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 should in 

particular target milk production holdings and raw milk upon collection. 

(12)  The requirements of this Regulation should not apply until all parts of the new legislation on 

food hygiene have entered into force.  It is also appropriate to provide for at least 18 months 

to elapse between entry into force and the application of the new rules, to allow competent 

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: 

1 

OJ L 184, 17.7.1999, p. 23. 

 
 
 
 
 
                                                 
 
CHAPTER I 

GENERAL PROVISIONS 

Article 1 

Scope 

1.   This Regulation lays down specific rules for the organisation of official controls on products of 

animal origin. 

2.   It shall apply only in respect of activities and persons to which Regulation (EC) No …/2004 * 

applies. 

3.   The performance of official controls pursuant to this Regulation shall be without prejudice to 

food business 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 1, and any civil or criminal 

liability arising from the breach of their obligations. 

* 

1 

Note for the OJ: insert number of Regulation laying down specific hygiene rules for food of 
animal origin (see recital 1, 2nd Regulation). 
OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation (EC) No 1642/2003 (OJ L 
245, 29.9.2003, p.4). 

 
 
 
 
 
 
 
                                                 
 
Article 2 

Definitions 

1.   For the purposes of this Regulation, the following definitions shall apply: 

(a) 

"official control" means any form of control that the competent authority performs for the 

verification of compliance with food law, including animal health and animal welfare rules; 

(b) 

"verification" means checking, by examination and the provision of objective evidence, 

whether specified requirements have been fulfilled; 

(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) 

"audit" means a systematic and independent examination to determine whether activities and 

related results comply with planned arrangements and whether these arrangements are 

implemented effectively and are suitable to achieve objectives; 

(e) 

"inspection" means the examination of establishments, of animals and food, and the 

processing thereof, of food businesses, 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 by the competent authority and working under the 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. 

2.   The definitions laid down in the following Regulations 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 

European Parliament and of the Council of 3 October 2002 laying down health rules 
concerning animal by-products not intended for human consumption 1; 

(c)  Regulation (EC) No …/2004 *, except for the definition of "competent authority"; and 

(d)  Regulation (EC) No …/2004 **. 

1  

*  

OJ L 273, 10.10.2002, p. 1.  Regulation as last amended by 
Commission Regulation (EC) No 813/2003 (OJ L 117, 13.5.2003, p. 22). 
Note for the Official Journal: insert number of Regulation on the hygiene of foodstuffs 
(see recital 1, 1st Regulation). 

**   Note for the Official Journal: insert number of Regulation laying down specific hygiene rules 

for food of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
 
                                                 
 
CHAPTER II 

OFFICIAL CONTROLS IN RELATION TO 

COMMUNITY ESTABLISHMENTS 

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 of Regulations (EC) No …/2004 * and No …/2004 ** and other relevant 

requirements of food law. 

(b) 

The competent authority may grant conditional approval if it appears from the on-site 

visit that the establishment meets all the infrastructure and equipment requirements.  

It shall grant full approval only if it appears from a new on-site visit carried out within 

three months of the granting of conditional approval that the establishment meets the 

other requirements referred to in (a).  If clear progress has been made but the 

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. 

*  

Note for the Official Journal: insert number of Regulation on the hygiene of foodstuffs 
(see recital 1, 1st Regulation). 

**   Note for the Official Journal: insert number of Regulation laying down specific hygiene rules 

for food of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
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. 

3.   The competent authority shall give each approved establishment, including those with 

conditional approval, an approval number, to which codes may be added to indicate the types of 

products of animal origin manufactured.  For wholesale markets, secondary numbers indicating 

units or groups of units selling or manufacturing products of animal origin may be added to the 

approval number. 

4. 

(a)  The competent authority shall keep the approval of establishments under review when 

carrying out official controls in accordance with Articles 4 to 8. 

(b) 

If the competent authority identifies serious deficiencies or has to stop production at an 

establishment repeatedly and the food business operator is not able to provide adequate 

guarantees regarding future production, the competent authority shall initiate procedures 

to withdraw the establishment's approval.  However, the competent authority may 

suspend an establishment's approval if the food business operator can guarantee that it 

will resolve deficiencies within a reasonable time. 

(c) 

In the case of wholesale markets, the competent authority may withdraw or suspend 

approval in respect of certain units or groups of units. 

 
 
 
 
 
 
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 no requirement for approval.  In the latter case, the competent 

authority's on-site visit required under paragraph 1 shall take place as soon as possible. 

Paragraph 4 shall also apply to approved establishments that placed products of animal origin on the 

market in accordance with Community legislation immediately prior to the application of this 

Regulation. 

6.   Member States shall maintain up-to-date lists of approved establishments, with their respective 

approval numbers and other relevant information, and make them available to other Member States 

and to the public in a manner that may be specified in accordance with the procedure referred to in 

Article 19(2). 

 
 
 
 
 
Article 4 

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

scope of this Regulation 

1.   Member States shall ensure that food business operators offer all assistance needed to ensure 

that official controls carried out by the competent authority can be performed effectively 

They shall in particular: 

– 

give access to all buildings, premises, installations or other infrastructures; 

– 

make available any documentation and record required under the present regulation or 

considered necessary by the competent authority for judging the situation. 

2.   The competent authority shall carry out official controls to verify food business operators' 

compliance with the requirements of: 

(a)  Regulation (EC) No …/2004*; 

*  

Note for the Official Journal: insert number of Regulation on the hygiene of foodstuffs 
(see recital 1, 1st Regulation). 

 
 
 
 
 
 
 
 
                                                 
 
(b)  Regulation (EC) No …/2004 *; and 

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

3.   The official controls referred to in paragraph 1 shall include: 

(a) 

audits of good hygiene practices and hazard analysis and critical control point 

(HACCP)-based procedures; 

(b) 

the official controls specified in Articles 5 to 8; and 

(c) 

any particular auditing tasks specified in the Annexes. 

4.   Audits of good hygiene practices shall verify that food 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; 

(d)  personal hygiene; 

(e) 

training in hygiene and in work procedures; 

*  

Note for the Official Journal: insert number of Regulation laying down specific hygiene rules 
for food of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
(f) 

pest control; 

(g)  water quality; 

(h) 

temperature control; and 

(i) 

controls on food entering and leaving the establishment and any accompanying 

documentation. 

5.   Audits of HACCP-based procedures shall verify that food business operators apply such 

procedures continuously and properly, having particular regard to ensuring that the procedures 
provide the guarantees specified in Section II of Annex II to Regulation (EC) No …/2004 *.  They 

shall, in particular, determine whether the procedures guarantee, to the extent possible, that products 

of animal origin: 

(a) 

comply with microbiological criteria laid down under Community legislation; 

(b) 

comply with Community legislation on residues, contaminants and prohibited substances; and 

(c) 

do not contain physical hazards, such as foreign bodies. 

When, in accordance with Article 5 of Regulation (EC) No …/2004 **, a food business operator 

uses procedures set out in guides to the application of HACCP principles rather than establishing its 

own specific procedures, the audit shall cover the correct use of these guides. 

*  

Note for the Official Journal: insert number of Regulation laying down specific hygiene rules 
for food of animal origin (see recital 1, 2nd Regulation). 

**   Note for the Official Journal: insert number of Regulation on the hygiene of foodstuffs 

(see recital 1, 1st Regulation). 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
6.   Verification of compliance with the requirements of Regulation (EC) No …/2004 * concerning 

the application of identification marks shall take place in all establishments approved in accordance 

with that Regulation, in addition to verification of compliance with other traceability requirements. 

7.   In the case of slaughterhouses, game handling establishments and cutting plants placing fresh 

meat on the market, an official veterinarian shall carry out the auditing tasks referred to in 

paragraphs 3 and 4. 

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

(a) 

to determine whether staff and staff activities in the establishment 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; 

(b) 

to verify the food business operator's relevant records; 

(c) 

to take samples for laboratory analysis whenever necessary; and 

(d) 

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

9.   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; 

*  

Note for the Official Journal: insert number of the Regulation laying down specific hygiene 
rules for food of animal origin (see recital 1,2nd Regulation). 

 
 
 
 
 
 
 
 
 
 
                                                 
 
(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 compliance with food law. 

Article 5 

Fresh meat 

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

with Annex I. 

(1)  The official veterinarian shall carry out inspection tasks in slaughterhouses, game handling 

establishments and cutting plants placing fresh meat on the market in accordance with the 

general requirements of Section I, Chapter II, of Annex I, and with the specific requirements 

of Section IV, in particular as regards: 

(a) 

food chain information; 

(b) 

ante-mortem inspection; 

(c) 

animal welfare; 

(d)  post-mortem inspection; 

 
 
 
 
 
 
 
 
 
 
 
 
(e) 

specified risk material and other animal by-products; and 

(f) 

laboratory testing. 

(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 cuts, shall be carried out in slaughterhouses and 

game-handling establishments in accordance with Section I, Chapter III, of Annex I.  Health 

marks shall be applied by, or under the responsibility of, the official veterinarian when official 

controls have not identified any deficiencies that would make the meat unfit for human 

consumption. 

(3)  After carrying out the controls mentioned in points 1 and 2, the official veterinarian shall take 

appropriate measures as set out in Annex I, Section II, in particular as regards: 

(a) 

the communication of inspection results; 

(b)  decisions concerning food chain information; 

(c)  decisions concerning live animals; 

(d)  decisions concerning animal welfare; and 

(e)  decisions concerning meat. 

 
 
 
 
 
 
 
 
 
(4)  Official auxiliaries may assist the official veterinarian with official controls carried out in 

accordance with Sections I and II of Annex I as specified in Section III, Chapter I.   

In that case, they shall work as part of an independent team. 

(5) 

(a)  Member States shall ensure that they have sufficient 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 involved shall be decided by the competent authority and shall be such that all the 

requirements of this Regulation can be met. 

 
 
 
 
 
(6) 

(a)   Member States may allow slaughterhouse staff to assist with official controls by 

carrying out certain specific tasks, under the supervision of the official veterinarian, in 

relation to the production of meat from poultry and lagomorphs in accordance with Annex I, 

Section III, Chapter III, Part A.  If they do so, they shall ensure that staff carrying out such 

tasks: 

(i) 

are qualified and undergo training in accordance with those provisions; 

(ii) 

act independently from production staff; and 

(iii)  report any deficiency to the official veterinarian. 

(b)  Member States may also allow slaughterhouse staff to carry out specific sampling and 

testing tasks in accordance with Annex I, Section III, Chapter III, Part B. 

(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 bivalve molluscs, 

live echinoderms, live tunicates and live marine gastropods undergo official controls as described in  

Annex II. 

Article 7 

Fishery products 

Member States shall ensure that official controls with respect to fishery products take place in 

accordance with Annex III. 

Article 8 

Raw milk and dairy products 

Member States shall ensure that official controls with respect to raw milk and dairy products take 

place in accordance with Annex IV. 

 
 
 
 
 
 
 
 
 
 
Article 9 

Action in the case of non-compliance 

1.   When the competent authority identifies non-compliance with the Regulations referred to in 

Article 4(2)(a) and (b), it shall take action to ensure that the food business operator remedies the 

situation.  When deciding which action to take, the competent authority shall take account of the 

nature of the non-compliance and the food business operator's past record with regard to non-

compliance. 

2.   Such action shall include, where appropriate, the following measures: 

(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) 

the suspension or withdrawal of the establishment's approval; 

(g) 

in the case of consignments from third countries, seizure followed by destruction or 

re-dispatch; 

(h) 

any other measure that the competent authority deems appropriate. 

3.   The competent authority shall provide the food business operator concerned, or a representative, 

with: 

(a)  written notification of its decision concerning the action to be taken in accordance with 

paragraph 1, together with the reasons for the decision; and 

(b) 

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

time limits. 

Where appropriate, the competent authority shall also notify the competent authority of the Member 

State of dispatch of its decision. 

 
 
 
 
 
 
 
 
 
CHAPTER III 

PROCEDURES CONCERNING IMPORTS 

Article 10 

General principles and conditions 

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. 

Article 11 

Lists of third countries and parts of third countries from which imports 

of specified products of animal origin are permitted 

1.   Products of animal origin shall be imported only from a third country or a part of third country 

that appears on a list drawn up and updated in accordance with the procedure referred to in 

Article 19(2). 

2.   A third country shall appear on such lists only if a Community control in that country has taken 

place and demonstrates that the competent authority provides appropriate guarantees as specified in 

paragraph 4.  However, a third country may appear on such lists without a Community control 

having taken place there if: 

(a) 

the risk determined in accordance with Article 18, 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. 

3.   Lists drawn up in accordance with this Article may be combined with other lists drawn up for 

public and animal health purposes. 

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

(a) 

the legislation of the third country on: 

(i) 

products of animal origin, 

(ii) 

the use of veterinary medicinal products, including rules on their prohibition or 

authorisation, their distribution, their placing on the market and the rules covering 

administration and inspection, and 

(iii) 

the preparation and use of feedingstuffs, including the procedures for using additives 

and the preparation and use of medicated feedingstuffs, as well as the hygiene quality of 

the raw materials used for preparing feedingstuffs and of the final product; 

(b) 

the organisation of the third countries' competent authorities, their powers and independence, 

the supervision to which they are subject and the authority that they have effectively to 

enforce the applicable legislation; 

(c) 

the training of staff in the performance of official controls; 

 
 
 
 
 
 
 
 
 
(d) 

the resources, including diagnostic facilities available to competent authorities; 

(e) 

the existence and operation of documented control procedures and control systems based on 

priorities; 

(f)  where applicable, the situation regarding animal health and procedures for notifying the 

Commission and relevant international bodies of outbreaks of animal diseases; 

(g) 

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

origin; 

(h) 

the assurances which the third country can give regarding compliance with, or equivalence to, 

Community requirements; 

(i) 

the hygiene conditions of production, manufacture, handling, storage and dispatch actually 

applied to products of animal origin destined for the Community; 

(j) 

any experience of marketing of the product from the third country and the results of any 

import controls carried out; 

(k) 

the results of Community controls carried out in the third country, in particular the results of 

the assessment of the competent authorities, and the action that competent authorities have 

taken in the light of any recommendations addressed to them following a Community control; 

 
 
 
 
 
 
 
 
(l) 

the existence, implementation and communication of an approved zoonoses control 

programme; and 

(m) 

the existence, implementation and communication of an approved residue control programme. 

5.   The Commission shall arrange for up-to-date versions of all lists drawn up or updated in 

accordance with this Article to be available to the public. 

Article 12 

List of establishments from which imports 

of specified products of animal origin are permitted 

1.   Products of animal origin may be imported into the Community only if they have been 

dispatched from, and obtained or prepared in, establishments that appear on lists drawn up and 

updated in accordance with this Article, except: 

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

Article 19(2), that the guarantees that a specified third country provides in respect of imports 

of specified products of animal origin are such that the procedure provided for in this Article 

is unnecessary to ensure compliance with the requirements of paragraph 2; and 

(b) 

in the cases specified in Annex V. 

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 manufactured from meat 

obtained in slaughterhouses and cutting plants appearing on lists drawn up and updated in 

accordance with this Article or in approved Community establishments. 

 
 
 
 
 
 
 
 
 
 
2.   An establishment may be placed on such a list only if the competent authority of the third 

country of origin guarantees that: 

(a) 

that establishment, together with any establishments handling raw material of animal origin 

used in the manufacture of the products of animal origin concerned, complies with relevant 

Community requirements, in particular those of Regulation (EC) No …/2004 *, or with 

requirements that were determined to be equivalent to such requirements when deciding to 

add that third country to the relevant list in accordance with Article 11; 

(b) 

an official inspection service in that third country supervises the establishments and makes 

available to the Commission, where necessary, all relevant information on establishments 

furnishing raw materials; and 

(c) 

it has real powers to stop the establishments from exporting to the Community in the event 

that the establishments fail to meet the requirements referred to under (a). 

3.   The competent authorities of third countries appearing on lists drawn up and updated in 

accordance with Article 11 shall guarantee that lists of the establishments referred to in paragraph 1 

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

4. 

(a)  The Commission shall provide the contact points that Member States have designated 

for this purpose with regular notifications concerning new or updated lists that it has 

received from the competent authorities of third countries concerned in accordance with 

paragraph 3. 

* 

Note for the OJ: insert number of Regulation laying down specific hygiene rules for food of 
animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(b) 

If no Member State objects to the new or updated list within 20 working days of the 

Commission's notification, 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). 

5.   The Commission shall arrange for up-to-date versions of all lists to be available to the public. 

Article 13 

Live bivalve molluscs, echinoderms, tunicates and marine gastropods 

1.   Notwithstanding Article 12(1)(b), live bivalve molluscs, echinoderms, tunicates and marine 

gastropods shall come from production areas in third countries that appear on lists drawn up and 

updated in accordance with Article 12. 

2.   The requirement of paragraph 1 shall not apply to pectinidae harvested outside classified 

production areas.  However, official controls with respect to pectinidae shall take place in 

accordance with Annex II, Chapter III. 

 
 
 
 
 
 
 
 
3. 

(a)  Before the lists referred to in paragraph 1 are drawn up, particular account shall be 

taken of the guarantees that the competent authority of the third country can give 

concerning compliance with the requirements of this Regulation on the classification 

and control of production zones. 

(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 production area to a list in 

accordance with 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 Regulation (EC) No …/2004 * and 

Regulation (EC) No …/2004 ** or provisions that are equivalent to those requirements; 

and 

(b) 

any special import conditions established in accordance with Article 18, point 19. 

3.   Documents may include details required in accordance with other Community legislation on 

public and animal health matters. 

4.   Exemptions from paragraph 1 may be granted in 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. 

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. 

* 

Note for the OJ: insert number of Regulation on the hygiene of foodstuffs (see recital 1, 
1st Regulation). 

**  Note for the OJ: insert number of Regulation laying down specific hygiene rules for food of 

animal origin (see recital 1, 2nd Regulation).  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 is flying and from the competent 

authority of another third country to which the former competent authority has 

delegated responsibility for the inspection of the vessel concerned, on condition 

that: 

– 

that third country appears on the list of third countries, drawn up in 

accordance with Article 11, from which imports of fisheries products are 

permitted, 

– 

all fishery products from the vessel concerned that are destined for placing 

on the market in the Community are landed directly in that third country, 

– 

the competent authority of that third country has inspected the vessel and 

has declared that it complies with Community requirements, and 

– 

the competent authority of that third country has declared that it will 

regularly inspect the vessel to ensure that it continues to comply with 

Community requirements;  

or 

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

third country the flag of which the vessel is flying and from the competent 

authority of a Member State, to which the former competent authority has 

delegated responsibility for the inspection of the vessel concerned, on condition 

that: 

– 

all fishery products from the vessel concerned that are destined for placing 

on the market in the Community are landed directly in that Member State, 

– 

the competent authority of that Member State has inspected the vessel and 

has declared that it complies with Community requirements, and 

– 

the competent authority of that Member State has declared that it will 

regularly inspect the vessel to ensure that it continues to comply with 

Community requirements. 

(c)  The Commission shall arrange for up-to-date versions of all lists drawn up or updated in 

accordance with this Article to be available to the public. 

3.   When fishery products are imported directly from a fishing or freezer vessel, a document signed 

by the captain may replace the document required under Article 14. 

4.   Detailed rules for the implementation of this Article may be laid down in accordance with the 

procedure referred to in Article 19(2). 

 
 
 
 
 
 
 
CHAPTER IV 

FINAL PROVISIONS 

Article 16 

Implementing measures and transitional measures 

Implementing measures and transitional arrangements may be laid down in accordance with the 

procedure referred to in Article 19(2). 

Article 17 

Amendment and adaptation of the Annexes 

1.   Annexes I, II, III, IV, V and VI may be amended or 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 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 4 to 7, national measures adapting the requirements laid down 

in Annex I. 

 
 
 
 
 
 
 
 
 
 
4.   The national measures referred to in paragraph 3 shall: 

(a) 

have the aim of: 

(i) 

enabling the continued use of traditional methods at any of the stages of production, 

processing or distribution of food;  

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

in regions that are 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; 

(ii) 

the presence of the competent authority in establishments. 

5.   Any Member State wishing to adopt national measures as referred to in paragraph 3 shall notify 

the Commission and other Member States.  Each notification shall: 

(a) 

provide a detailed description of the requirements that that Member State considers need to be 

adapted and the nature of the adaptation sought; 

(b)  describe the establishments concerned; 

 
 
 
 
 
 
 
 
 
 
 
 
(c) 

explain the reasons for the adaptation, including, where 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 Regulation; 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, if necessary, to appropriate amendments.  Where appropriate, the Commission may propose 

general measures in accordance with paragraphs 1 or 2 of this Article. 

7.   A Member State may adopt national measures adapting the requirements of Annex I only: 

(a) 

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

(b) 

if, one month after the expiry of the period referred to in paragraph 6, the Commission has not 

informed Member States that it has received written comments or that it intends to propose 

the adoption of a decision in accordance with paragraph 6. 

8.  When a Member State adopts national measures 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 

Without prejudice to the generality of Article 16 and Article 17(1), implementing measures may be 

laid down, or amendments to Annexes I, II, III, IV, V or VI adopted, in accordance with the 

procedure referred to in Article 19(2), to specify: 

1) 

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

2) 

the method of communicating inspection results; 

3) 

criteria to determine when, on the basis of a risk analysis, the official veterinarian need not be 

present in slaughterhouses and game handling establishments throughout ante-mortem and 

post-mortem inspection; 

4) 

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

5)  microbiological criteria for process control in relation to hygiene in establishments; 

6) 

alternative procedures, serological or other laboratory tests that provide guarantees at least 

equivalent to specific post-mortem inspection procedures described in Annex I, Section IV, 

and may therefore replace them, if the competent authority so decides; 

 
 
 
 
 
 
 
 
 
 
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; 

9) 

the cold treatment to be applied to meat in relation to cysticercosis and trichinosis; 

10)  conditions under which holdings and regions can be certified as officially free of cysticercus 

or trichinae; 

11)  methods to be applied when examining for the conditions referred to in Annex I, Section IV, 

Chapter IX; 

12) 

for fattening pigs, criteria for controlled housing conditions and integrated production 

systems; 

13)  criteria for the classification of production and relaying areas for live bivalve molluscs in 

cooperation with the relevant Community Reference Laboratory, including: 

(a) 

limit values and analysis methods for marine biotoxins, 

(b)  virus testing procedures and virological standards, and 

(c) 

sampling plans and the methods and analytical 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 environmental 

contaminants; 

16) 

the method by which the Commission will make lists of third countries and establishments in 

third countries available to the public pursuant to Articles 11, 12, 13 and 15; 

17)  models for documents and criteria for the use of electronic documents; 

18)  criteria for determining the risk that particular products of animal origin imported into the 

Community present; 

19) 

special import conditions for particular products of animal origin, taking account of the 

associated risks, information that relevant third countries have provided and, where 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. 

 
 
 
 
 
 
 
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. 

Article 20 

Consultation of the European Food Safety Authority 

The Commission shall consult the European Food Safety Authority on matters falling within the 

scope of this Regulation 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 

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. 

2.   The Commission shall, if appropriate, accompany the report with relevant proposals. 

Article 22 

Entry into force 

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

Journal of the European Union. 

*  

Five years after the entry into force of this Regulation. 

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

(a)  Regulation (EC) No …/2004 *; 

(b)  Regulation (EC) No …/2004 ** 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 1. 

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

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

Done at Strasbourg, 29 April 2004. 

 For the European Parliament 

The President 

     P. COX 

For the Council 

The President 

M. McDOWELL 

* 

Note for the Official Journal: insert number of Regulation on the hygiene of foodstuffs 
(see recital 1, 1st Regulation). 

**  Note for the Official Journal: insert number of Regulation laying down specific hygiene rules 

for food of animal origin (see recital 1, 2nd Regulation). 
See p.       of this Official Journal. 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
FRESH MEAT 

SECTION I: TASKS OF THE OFFICIAL VETERINARIAN 

ANNEX I 

CHAPTER I: AUDITING TASKS 

1. 

In  addition  to  the  general  requirements  of  Article 4(4)  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(5)  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). 

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 *. 

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. 

*  

Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food 
of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
 
                                                 
 
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. 

5.  In  the  event  of  an  emergency  slaughter,  the  carcass  shall  be  subjected  to  post-mortem 

examination as soon as possible in accordance with paragraphs 1 to 4 before it is released 

for human consumption. 

E. 

Specified risk material and other animal by-products  

In accordance with specific Community rules on specified risk material and other animal 

by-products, the official 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. 

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; 

1 

OJ L 147, 31.5.2001, p. 1.  Regulation as last amended by Commission Regulation (EC) 
No 2245/2003 (OJ L 133, 20.12.2003, p. 28). 

 
 
 
 
 
 
 
 
 
 
 
                                                 
 
(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 1; 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 Regulation and 

when there  are  no  grounds  for  declaring  the  meat  unfit  for  human  consumption. 

However,  the  health  mark  may  be  applied  before  the  results  of  any  examination 

for  trichinosis  is  available,  if  the  official  veterinarian  is  satisfied  that  meat  from 

the  animal  concerned  will  be  placed  on  the  market  only  if  the  results  are 

satisfactory; and 

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). 

 
 
 
 
 
 
 
 
 
 
                                                 
(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 *. 

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. 

2. 

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

(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. 

*  

Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food 
of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
 
 
                                                 
 
(b) 

When  the  problem  identified  arose  during  primary  production,  the official 

veterinarian  is  to  inform  the  veterinarian  attending  the  holding  of  provenance, 

the food  business  operator  responsible  for  the  holding  of  provenance  (provided 

that  such  information  would  not  prejudice  subsequent  legal  proceedings)  and, 

where  appropriate,  the  competent  authority  responsible  for  supervising  the 

holding of provenance or the hunting area. 

(c) 

If  the  animals  concerned  were  raised  in  another  Member  State  or  in  a  third 

country,  the  official  veterinarian  is  to  inform  to  the  competent  authority  of  the 

Member State where the establishment is located. That competent authority is to 

take appropriate measures in accordance with applicable Community legislation. 

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

4.  When  the  official  veterinarian,  while  carrying  out  ante-mortem  or  post-mortem 

inspection  or  any  other  inspection  activity,  suspects  the  presence  of  an  infectious  agent 

mentioned on OIE List A or, where appropriate, OIE List B, the official veterinarian must 

immediately notify the competent authority and both must take all necessary measures and 

precautions  to  prevent  the  possible  spread  of  the  infectious  agent  in  accordance  with 

applicable Community legislation. 

 
 
 
 
 
 
 
CHAPTER II: DECISIONS CONCERNING FOOD CHAIN INFORMATION 

1.  The  official  veterinarian  is  to  verify  that  animals  are  not  slaughtered  unless  the 

slaughterhouse  operator  has  been  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. 

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 *  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 *  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. 

*  

Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food 
of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
                                                 
 
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. 

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 *; 

(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) derives from animals affected by a generalised disease, such as generalised septicaemia, 

pyaemia, toxaemia or viraemia; 

(g) is  not  in  conformity  with  microbiological  criteria  laid  down  under  Community 

legislation to determine whether food may be placed on the market; 

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

*  

Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food 
of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
(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; 

(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  establishments  identified  on  the  basis  of  a  risk  analysis  and  in  accordance  with 

criteria laid down in accordance with Article 18, point 3, if there are any. In such cases: 

(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 veterinarian to be satisfied that standards are being met. 

However, in the case of poultry and lagomorphs, the official auxiliary may discard meat with 

abnormalities  and,  subject  to  Section IV,  the  official  veterinarian  need  not  systematically 

inspect all such meat. 

 
 
 
 
 
 
 
 
 
 
 
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. 

1  

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

 
 
 
 
 
 
 
 
 
 
 
                                                 
 
CHAPTER III: INVOLVEMENT OF SLAUGHTERHOUSE STAFF 

A. 

SPECIFIC TASKS CONCERNING THE PRODUCTION OF MEAT FROM POULTRY 
AND LAGOMORPHS 

The  Member  States  may  permit  slaughterhouse  staff  to  take  over  the  activities  of  the  official 

auxiliaries in controlling the production of poultry and rabbit meat under the following conditions: 

(a)  Where  the  establishment  has  used  good  hygiene  practice  in  accordance  with  Article 4, 

paragraph  4  of  this  Regulation  and  the  HACCP  procedure  for  at  least  twelve  months,  the 

competent  authority  may  authorise  staff  of  the  establishment  who  have  been  trained  in  the 

same way as the official assistants and have passed the same examination to carry out tasks of 

the  official  auxiliaries  and  form  part  of  the  competent  authority's  independent  inspection 

team, under the supervision, direction and responsibility of the official veterinarian. In these 

circumstances,  the  official  veterinarian  shall  be  present  at  anti-mortem  and  post-mortem 

examinations, shall supervise these activities and carry out regular performance tests to ensure 

that the performance of the slaughterhouse tasks meets the specific criteria laid down by the 

competent authority, and shall document the results of those performance tests. Detailed rules 

for  the  performance  tests  shall  be  laid  down  in  accordance  with  the  procedure  set  out  in 

Article  18.  Where  the  level  of  hygiene  of  the  establishment  is  affected  by  the  work  of  this 

staff,  where  this  staff  does  not  carry  out  the  tasks  properly  or  where  in  general  this  staff 

carries  out  its  work  in  a  manner  that  the  competent  authority  considers  unsatisfactory,  this 

staff shall be replaced by official auxiliaries. 

 
 
 
 
 
 
 
 
Responsibilities for production and inspection in the establishment must be kept separate and 

any establishment wishing to use the establishment's own inspectors must possess 

internationally recognised certification. 

(b)  The competent authority of the Member State shall decide, in principle and on a case-by-case 

basis,  whether  to  permit  the  implementation  of  the  system  described  above.  Where  the 

Member State decides in principle in favour of this system, it shall inform the Commission of 

that  decision  and  its  associated  conditions.  For  food  business  operators  in  a  Member  State 

implementing  the  system,  the  actual  use  of  the  system  is  optional.  Food  business  operators 

shall not be forced by the competent authority to introduce the system described here. Where 

the  competent  authority  is  not  convinced  that  the  food  business  operator  satisfies  the 

requirements,  the  system  shall  not  be  implemented  in  that  establishment.  In  order  to  assess 

this,  the  competent  authority  shall  carry  out  an  analysis  of  the  production  and  inspection 

records, the type of activities undertaken in the establishment, the history of compliance with 

rules,  the  expertise,  professional  attitude  and  sense  of  responsibility  of  the  slaughterhouse 

staff in regard to food safety, together with other relevant information. 

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; 

(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. 

(7) Notwithstanding  paragraphs  1  to  6,  Member  States  may  lay  down  specific    rules  for 

official veterinarians working on a part-time basis who are responsible for inspecting small 

businesses 

B. 

OFFICIAL AUXILIARIES 

1.  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. 

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, 
examination for trichinosis, 
post-mortem inspection, 
administrative tasks, 
knowledge  of 
provisions, 
sampling procedure, 
fraud aspects; 

laws,  regulations  and  administrative 

the  relevant 

 
 
 
 
 
 
(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; 

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; 

 
 
 
 
 
 
 
 
 
 
 
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 supramammary 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. 

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; 

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

lymph  nodes  (Lnn.  gastrici,  mesenterici,  craniales  and  caudales);  palpation  and,  if 

necessary, incision of the gastric and mesenteric lymph nodes; 

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

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

lymph nodes (Lnn. renales); 

(i) visual inspection of the pleura and peritoneum; 

(j) visual inspection 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; 

(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. 

 
 
 
 
 
 
 
 
 
 
 
C. 

SPECIMEN HEALTH CERTIFICATE 

HEALTH CERTIFICATE 
for poultry intended for the production of foie gras and delayed eviscerated poultry slaughtered at 
the holding of provenance 

Competent service: ................................................................................................................................  
No: .........................................................................................................................................................  

Identification of uneviscerated carcases 

1. 
Species:  .................................................................................................................................................  
Number:  ................................................................................................................................................  

2. 
Address of holding: ...............................................................................................................................  

Provenance of uneviscerated carcases 

Destination of uneviscerated carcases 

3. 
The uneviscerated carcases will be transported to the following cutting plant:  ...................................  
................................................................................................................................................................  

Declaration 
4. 
I, the undersigned, declare that: 

– 

– 

the uneviscerated carcases described above are of birds which were examined before 
slaughter on the above-mentioned holding at …….…. (time) on …….…. (date) and 
found to be healthy; 
the records and documentation concerning these animals satisfied the legal 
requirements and do not prohibit slaughter of the birds. 

Done at:  ................................................................................................................................................ , 
(Place) 
on:  .........................................................................................................................................................  
 (Date) 

Stamp 

………………………………………….. 
(Signature of the official or approved veterinarian) 

 
 
 
 
 
 
 
 
 
 
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 *  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  slaughterhouse,  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. 

*  

Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food 
of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
 
 
 
                                                 
 
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 *. 

*  

Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food 
of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
 
 
 
 
                                                 
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; 

(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. 

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  ramifications,  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 contamination 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  contamination  of  other  carcases, 

the slaughter line and staff present in the slaughterhouse. 

2.  Meat  from  animals  in  which  post  mortem  inspection  has  revealed  lesions  indicating 

acute infection with 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. 

CHAPTER X: SPECIMEN HEALTH CERTIFICATE 

A. 

SPECIMEN HEALTH CERTIFICATE FOR LIVE ANIMALS 

HEALTH CERTIFICATE 
for live animals transported from the holding to the slaughterhouse 

Competent service: ................................................................................................................................  
No: .........................................................................................................................................................  
1. 
Species:  .................................................................................................................................................  
Number of animals: ...............................................................................................................................  
Identification marking: ..........................................................................................................................  

Identification of the animals 

Provenance of the animals 

2. 
Address of holding of provenance:  .......................................................................................................  
Identification of house*:  ........................................................................................................................  

Destination of the animals 

3. 
The animals will be transported to the following slaughterhouse:  .......................................................  
................................................................................................................................................................  
by the following means of transport:  ....................................................................................................  

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

Other relevant information 

 
 
 
 
 
 
 
 
 
 
 
 
 
5. 

Declaration 

I, the undersigned, declare that: 

the animals described above were examined before slaughter at the above-mentioned 
holding at …….…. (time) on …….…. (date) and were found to be healthy, 
the records and documentation concerning these animals satisfied the legal 
requirements and do not prohibit slaughter of the animals. 

– 

– 

– 

Done at:  ................................................................................................................................................ , 
(Place) 
on:  .........................................................................................................................................................  
(Date) 

Stamp 

* optional 

………………………………………….. 
(Signature of official or approved veterinarian) 

B. 

SPECIMEN  HEALTH  CERTIFICATE  FOR  ANIMALS  SLAUGHTERED  AT  THE 
HOLDING 

HEALTH CERTIFICATE 
for animals slaughtered at the holding 

Competent service: ................................................................................................................................  
No: .........................................................................................................................................................  
1. 
Species:  .................................................................................................................................................  
Number of animals: ...............................................................................................................................  
Identification marking: ..........................................................................................................................  

Identification of the animals 

Provenance of the animals 

2. 
Address of holding of provenance:  .......................................................................................................  
Identification of house*:  .......................................................................................................................  

 
 
 
 
 
 
 
 
 
Destination of the animals 

3. 
The animals will be transported to the following slaughterhouse:  .......................................................  
................................................................................................................................................................  
by the following means of transport:  ....................................................................................................  

Other relevant information 

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

Declaration 

I, the undersigned, declare that: 

the animals described above were examined before slaughter at the above-mentioned 
holding at …….…. (time) on …….…. (date) and were found to be healthy, 
they were slaughtered at the holding at …….…. (time) on …….…. (date) and 
slaughter and bleeding were carried out correctly, 
the records and documentation concerning these animals satisfied the legal 
requirements and did not prohibit slaughter of the animals. 

– 

– 

– 

– 

Done at:  ................................................................................................................................................ , 
(Place) 
on:  .........................................................................................................................................................  
(Date) 

Stamp 

* optional 

………………………………………….. 
(Signature of official or approved veterinarian) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
LIVE BIVALVE MOLLUSCS 

ANNEX II 

CHAPTER I: SCOPE 

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

live marine gastropods. 

CHAPTER  II:  OFFICIAL  CONTROLS  CONCERNING  LIVE  BIVALVE  MOLLUSCS  FROM  CLASSIFIED 

PRODUCTION AREAS 

A. 

CLASSIFICATION OF PRODUCTION AND RELAYING AREAS 

1.  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  appropriate,  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 *. 

*  

Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food 
of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
                                                 
 
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; 

(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. 

1 

OJ L 77, 16.3.2001, p. 1.  Regulation as last amended by Regulation (EC) No 655/2004 (OJ L 
104, 8.4.2004, p. 48). 

 
 
 
 
 
                                                 
 
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. 

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 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 * as well as compliance with other requirements of 

Annex III, Section VII, Chapter IX, to that Regulation. 

__________________ 

*  

Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food 
of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
                                                 
 
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. 

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 * and comply 

with the standards laid down in Chapter V, point 2, of that Section. 

CHAPTER III: DECISIONS AFTER CONTROLS 

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

1.  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; 

*  

Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food 
of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
 
                                                 
 
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 *; 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. 

*  

Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food 
of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
RAW MILK AND DAIRY PRODUCTS 

CHAPTER I: CONTROL OF MILK PRODUCTION HOLDINGS 

ANNEX IV 

1.  Animals on milk production holdings must be subject to official controls to verify that 

the health requirements for raw milk production, and in particular the health status of the 

animals  and  the  use  of  veterinary  medicinal  products,  are  being  complied  with.  

These controls may take place at the occasion of veterinary checks carried out pursuant to 

Community  provisions  on  animal  or  public  health  or  animal  welfare  and  may  be  carried 

out by an approved veterinarian. 

2.  If  there  are  grounds  for  suspecting  that  the  animal  health  requirements  are  not  being 

complied with, the general health status of the animals is to be checked. 

3.  Milk  production  holdings  are  to  undergo  official  controls  to  verify  that  hygiene 

requirements  are  being  complied  with.  These  official  controls  may  involve  inspections 

and/or  the  monitoring  of controls  that professional organisations  carry  out.  If it  is  shown 

that  the  hygiene  is  inadequate,  the competent  authority  is  to  verify  that  appropriate  steps 

are taken to correct the situation. 

 
 
 
 
 
 
 
CHAPTER II: CONTROL OF RAW MILK UPON COLLECTION 

1.  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 *. 

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. 

*  

Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food 
of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
ANNEX V 

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

The following third country establishments need not appear on lists drawn up and updated in 

accordance with Article 12(4): 

1. 

establishments  handling  products  of 
animal  origin 
Regulation (EC) No…/2004 * does not lay down requirements; 

for  which  Annex III 

to 

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. 

*  

Note for Official Journal: Insert No of Regulation laying down specific hygiene rules for food 
of animal origin (see recital 1, 2nd Regulation). 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
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.