Amended proposal for a Regulation of the European Parliament and of the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (presented by the Commission pursuant to article 250 (2) of the EC Treaty)
Date: 2003-10-21
Institutions: European Commission
Subjects: animal product, food inspection, human nutrition, veterinary inspection, veterinary legislation

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 21.10.2003
COM(2003) 577 final

2002/0141 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying down specific rules for the organisation of official controls on products of animal
origin intended for human consumption

(presented by the Commission pursuant to article 250 (2) of the EC Treaty)

EXPLANATORY MEMORANDUM

I.

PROCEDURE

1.

2.

3.

On 11 July 2002, the Commission adopted its proposal for a Regulation of the
European  Parliament  and  of  the  Council  laying  down  specific  rules  for  the
organisation  of  official  controls  on  products  of  animal  origin  intended  for
human  consumption  [Document  COM  (2002)  377  final].  The  proposal  was
submitted  to  the  Council  and  the  European  Parliament  on  the  same  day  for
adoption pursuant to Article 251 of the Treaty.

On 5 June 2003, the European Parliament in its  first  reading  gave its opinion
on the proposal.

The  present  proposal  amends  the  original  proposal  so  as  to  take  into  account
the  amendments  of  the  European  Parliament  that  were  accepted  by  the
Commission.

4. With  regard  to  the  original  proposal,  the  European  Parliament  adopted  136
amendments. The Commission had indicated to the plenary meeting on 6 June
2003 that it could accept more than half of the amendments, wholly or in part,
and subject to drafting amendments. The amendments that cannot be accepted
by the Commission are: 2, 4, 6, 10, 14, 15, 21 (point 6), 25, 30, 31, 33, 36, 37,
38, 44, 46, 55, 58, 59, 60, 62, 63, 64, 65, 67, 68, 69, 70, 71, 72, 73, 75, 76, 77,
78, 80, 81, 83, 86, 87 (middle part), 88 (first part), 90, 100, 101, 102, 103, 105,
106,  107,  109,  112,  114,  117,  118,  119,  122  (first  part),  123,  125,  126,  127,
128, 129, 135, 136, 137, 139, 140, 143.

5.

The amendments accepted in the revised proposal are in bold and underlined.
A number of amendments have been reformulated so as to ensure consistency
of  the  terminology  used  throughout  the  proposal,  or  to  bring  the  text  in  line
with  the  approach  of  the  Council.  The  numbering  of  the  Articles  has  been
adapted to take into account a number of amendments.

II.

OBJECTIVES OF THE PROPOSAL

6.

7.

The  proposal  concerns  the  recast  and  modernisation  of  specific  Community
rules on the official controls on  food  of  animal  origin.  The  proposal  contains
specific  rules  for  official  controls  on  meat  and  meat  products,  live  bivalve
molluscs, fishery products and milk and milk products. The proposal is part of
the package on the recast of Community hygiene rules, proposal COM (2000)
438 final.

The main purpose of the proposal is to make existing rules more science- and
risk-based,  and  to  bring  them  in  line  with  the  hygiene  requirements  for
operators, proposed in the other parts of the package on the recast of hygiene
rules.

2

III.

OVERVIEW OF THE AMENDMENTS OF THE EUROPEAN PARLIAMENT

Technical and editorial amendments

8.

A large number of the proposed amendments aim to improve the proposal from
a technical and editorial point of view. These are the amendments 1, 5, 7, 8, 9,
13, 14, 16, 17, 18, 20, 22, 23, 24, 26, 39, 40, 41, 42, 43, 44, 45, 46, 50, 53, 54,
55, 56, 58, 59, 66, 67, 74, 76, 78, 79, 84,  104,  105, 106, 108,  110,  111, 112,
113, 114, 115, 117, 118, 129, 137.

to  editorial  changes).  However,  certain  of 

9. Most  of  these  amendments  are  welcomed  by  the  Commission  (in  some  cases
subject 
these  amendments
unnecessarily  tighten  the  requirements  of  the  proposal.  In  other  cases,  more
appropriate wording  has been  proposed in  the  framework of the work  carried
out in Council. These amendments should therefore be rejected. These are: 2,
14, 44, 46, 55, 58, 59, 67, 68, 69, 75, 76, 77, 78, 80, 105, 106, 112, 114, 117,
118, 119, 128, 129, 137.

Transfer of requirements from Annexes to Articles (Article 4)

10. Amendment  21  aims  at  ensuring  that  all  the  basic  requirements  as  regards
official  controls  on  meat  appear  in  the  Articles.  This  would  ensure  legal
security for food businesses. Amendment 21 is in principle acceptable, subject
to editorial changes. However, point 6 of the Amendment cannot be accepted
as it conflicts with the policy of the Commission as regards the use of company
staff for certain control activities.

Relation with the future Regulation on official feed and food controls

11. The amendments 4, 25 and 70 concern subjects that are being dealt with in the
Commission  proposal  for  a  Regulation  on  official  feed  and  food  controls
[COM(2003)52 final], especially the costs, the right of appeal and, to a minor
extent,  the  issue  of  penalties.  These  amendments  cannot  be  accepted  as  the
issues  concerned  should  be  dealt  with  under  the  proposed  Regulation  on
official feed and food controls.

Flexibility for small businesses (Recital 9 and Article 16)

12. Three  amendments  (3,  15  and  138)  aim  at  introducing  extra  flexibility  as

regards official controls in small meat businesses.

13. The amendments 3 and 138  are  acceptable  (subject to editorial amendments),
as  they  refer  to  the  flexibility  agreed  upon  in  the  framework  of  the  political
agreement  (at  Council  level)  on  other  parts  of  the  package  on  the  recast  of
Community  hygiene  rules  [proposal  COM  (2000)  438  final].  Amendment  15
cannot be accepted as it introduces the concept of ‘artisanal small businesses’,
a concept that conflicts with the general food safety policy of the Commission.

3

Comitology ( Article 17, Article 18 and Annex 1, Chapter 3, Section IX.G)

14. A  number  of  amendments  have  been  tabled  that  are  related  to  the  issue  of
comitology.  Amendment  38  deletes  the  possibility  of  comitology,  but  this  is
partly  reintroduced  by  116,  120  and  131  (and  some  other  amendments  dealt
with hereunder), and notably by amendment 130.

15. Amendment  38  cannot  be  accepted  as  it  deprives  the  Commission  of  the
possibility  to  take  implementing  decisions  and  to  amend  the  annexes.  The
amendments  116,  120  and  131  can  in  principle  be  accepted  as  a  whole  or  in
part,  subject  to  editorial  amendments.  Amendment  130  is  welcomed  as  it
reintroduces the possibility for the Commission to take implementing decisions
or change certain rules under comitology.

Imports (Articles 8-15)

16. The  amendments  27,  28,  29,  30,  31,  32,  33,  34,  35,  36  and  37  aim  at
introducing in the text requirements for imports that were previously contained
in  ‘Hygiene  2’.  This  is  in  principle  in  line  with  the  approach  of  the
Commission and of the Council. However, the detailed requirements contained
in  these  amendments  are  not  always  consistent  with  the  approach  of  the
Commission  and  of  the  Council,  and  sometimes  duplicate  the  Commission
proposal on official feed and food controls. The amendments 30, 31, 33, 36 and
37  can  therefore  not  be  accepted.  The  other  amendments  require  important
redrafting.

Food chain information (Annex I, Chapter 1, section I.2.A)

17. A number of amendments aim at introducing flexibility in the system of food
chain  information  (information  from  the  farm  that  has  to  accompany  the
animals  to  slaughter).  These  are  the  amendments  47,  48,  49,  51,  71,  72,  73,
101, 102, 103 and 107.

18. Amendments 47, 48, 49 and 51 are acceptable. However, amendments 71, 72,
73, 101, 102, 103 and 107 would dilute the system and render it ineffective. As
regards  the  identification  of  animals  in  particular,  animals  whose  identity
cannot  be  ascertained  should  in  principle  not  be  slaughtered  for  human
consumption. These amendments can therefore not be accepted.

Health marking (Annex I, Chapter 1, Section I.2.G, paragraph 3)

19.

In the framework of the political agreement at Council on ‘Hygiene 2’, it has
been decided that health marking would be limited to red meat (thus excluding
poultry and rabbits) at the level of the slaughterhouse, as it was considered that
systematic  official  carcass-by-carcass  inspection  was  only  required  at  this
level.

4

20. The amendments 60, 62, 63, 64 and 65  cannot be  accepted as  they  are  not in
line with this approach. Amendment 61 can be accepted, partly and subject to
editorial amendments, as it brings some aspects of health marking in line with
the practical situation in slaughterhouses.

Visual post-mortem inspection (Annex I, Chapter 3, Section IV.B, paragraph 2)

21. On  the  basis  of  scientific  advice  (SCVPH),  the  possibility  of  visual  post-
mortem inspection of certain categories of fattening pigs had been introduced
in 
this  possibility.
Amendment 109 can therefore not be accepted.

text.  Amendment  109  eliminates 

the  Commission 

The use of company staff in control activities (Article 4)

22. The Commission text provides for the possibility of the use of  company staff
for certain control activities. A number of amendments have been adopted that
aim at bringing this company staff very much into the sphere of the competent
authority. The Commission believes these two things should be kept separate.
The amendments 81, 83 and 87 (partly) can therefore not be accepted.

23. The rest of Amendment 87 can however be accepted as the Commission agrees
to  introduce  some  extra  requirements  for  the  establishments  using  company
staff in control activities. Amendment 100 cannot be accepted as it eliminates
some necessary flexibility as regards the training of company staff.

24. A  number  of  amendments  have  been  adopted  that  seriously  limit  the  use  of
company  staff.  These  cannot  be  accepted.  These  are  127,  135,  136,  139  and
140.

Presence  of  the  official  veterinarian  (Annex  I,  Chapter  2,  Section  II,
paragraph 2(a), subparagraph 1)

25. Amendment  85  can  be  accepted,  subject  to  editorial  changes,  as  it  states  that
the  presence  of  the  official  veterinarian  in  small  slaughterhouses  should  be
based  on  an  analysis  of  risks.  This  is  in  line  with  the  original  Commission
proposal.

Training (Annex I, Chapter 2, Section IV.A)

26. The Environment Committee has adopted a large number of amendments that
deal  with  the  training  requirements  for  official  veterinarians  and  official
auxiliaries. These are the amendments 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98
and 99. These are nearly all very technical. Some however aim at introducing
flexibility  as  regards  the  training  requirements  for  veterinarians  that  already
work or deal with small artisanal businesses.

27. Nearly  all  amendments  can  be  accepted  as 

technical
specifications that are more or less in line with the general food safety policy.
The  amendments  88  (partly)  and  90  cannot  be  accepted  as  they  aim  at
introducing extra flexibility  as regards the training of veterinarians, flexibility
that is already sufficiently provided for in the original Commission proposal.

integrate 

they 

5

Live bivalve molluscs and fishery products (Annex II, Section I, point 4(b) and
(c), and Annex III, point 1)

28. A  number  of  amendments  have  been  tabled  that  specifically  concern  live
bivalve  molluscs  and  fishery  products.  Most  of  these  concern  the  issue  of
marine biotoxins in molluscs. These are the amendments 6, 121, 122, 123, 124,
125  and  126.  The  amendments  121  and  124  are  welcomed  as  they  contain
useful specifications.

29. Amendments  6,  122  (partly)  and  123  cannot  be  accepted  as  they  aim  at
unnecessarily weakening the provisions for marine biotoxins. Amendment 125
cannot  be  accepted  as  it  contains  a  specification  that  may  be  confusing.
Amendment 126 cannot be  accepted as it unnecessarily limits  the freedom of
action by the competent authority in case of risks.

Various

30. This covers the amendments tabled on various other subjects. Amendments 11
and  12  concern  the  scope  of  the  Regulation  (Article  1),  19  concerns
communication of the lists of approved establishments (Article 3, paragraph 3),
52 animal welfare (Annex I, Chapter 1, Section I.2.C), 57 emergency slaughter
(Annex I, Chapter 1, Section I.2.D, point 6), 82 the tasks of official auxiliaries
(Annex  I,  Chapter  2,  Section  I(b),  110  the  approved  veterinarian  (Annex  I,
Chapter 3, Section VII.B, point 3), 132 and 133 ‘pronounced sexual odour’ in
pig  meat  (Annex  I,  Chapter  1,  Section  II.E(p),  and  134  the  presence  of  the
competent authority in cutting plants (Annex I, Chapter 2, Section II, point 5).

31. Certain technical changes have been made to the text to improve its conformity
with  the  Interinstitutional  Agreement  of  22  December  1998  on  common
guidelines  for  the  quality  of  drafting  of  Community  legislation  (OJ  C  73,
17.3.1999, p. 1), drawn up pursuant to Declaration No 39 annexed to the Final
Act of Amsterdam on the quality of the drafting of Community legislation. In
accordance with points (b) and (g) of that Agreement, the text has been revised
to take account of the common guidelines and the Joint Practical Guide drawn
up under point (a) thereof.

Conclusion

Pursuant  to  Article  250(2)  of  the  EC  Treaty,  the  Commission  is  amending  its
proposal as indicated above.

6

2002/0141 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying down specific rules for the organisation of official controls on products of animal
origin intended for human consumption

(EEA relevance)

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 Commission1,

Having regard to the opinion of the European Economic and Social Committee2,

Having regard to the opinion of the Committee of the Regions3,

Acting in accordance with the procedure laid down in Article 251 of the Treaty4,

Whereas:

(1) 

(2) 

(3) 

1

2

3

4

5

6

7

8

Regulation (EC) No …/… of the European Parliament and of the Council of … on the
hygiene  of  foodstuffs5  lays  down  general  hygiene  rules  applying  to  all  foodstuffs,
while  specific  hygiene  rules  for  food  of  animal  origin  are  contained  in  Regulation
(EC)  No  …/…  of  the  European  Parliament  and  of  the  Council  of  …  laying  down
specific hygiene rules for food of animal origin6.

Regulation  (EC)  No  …/…  of  the  European  Parliament  and  of  the  Council  of  …  on
official  feed  and  food  controls7  lays  down  the  general  rules  for  performing  official
controls of foodstuffs.

Council Directive 2002/99/EC of 16 December 2002 lays down the animal health rules
governing  the  production,  processing,  distribution  and  introduction  of  products  of
animal origin for human consumption8.

OJ C […], […], p. […].
OJ C […], […], p. […].
OJ C […], […], p. […].
OJ C […], […], p. […].
OJ C […], […], p. […].
OJ C […], […], p. […].
OJ C […], […], p. […].
OJ L 18, 23.1.2003.

7

                                                
(4) 

(5) 

(6) 

(7) 

(8) 

Regulation  (EC)  No  1774/2002  of  the  European  Parliament  and  of  the  Council  of  3
October 2002 lays down the health rules concerning animal by-products not intended
for human consumption9.

In addition to the general rules for performing official controls of foodstuffs, specific
rules should be laid down for official controls on products of animal origin in order to
take account of the specific aspects associated with such products.

Official  controls  on  products  of  animal  origin  should  cover  all  aspects  which  are
important  for  protecting  public  health,  animal  health  and  animal  welfare  and  for
consumers to be provided with suitable and healthy food. They should be based on the
most  recent  information  available  and  should  therefore  be  adapted  as  relevant  new
information becomes available.

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

The nature and intensity of the official controls should be based on an assessment of
the  public  and  animal  health  risks,  the  animal  welfare  aspects  and  the  product
suitability aspects related to the species  and category of animals, the  type of process
and the food business operator concerned.

(9)  Official  controls  should  take 

into  account  the  flexibility  for  traditional
in
production,  remote  areas,  and  structural  requirements,  provided  for 
Regulation  (EC)  No.  …/…  [on  food  hygiene],  and  Regulation  (EC)  No.  …/…
[laying  down  specific  hygiene  rules  for  food  of  animal  origin].  Such  flexible
treatment should not entail lowering the overall level of hygiene.

(10)  Official  controls  on  the  production  of  meat  should  be  carried  out  to  ensure  that
hygiene  rules  are  continuously  being  respected  and  that  the  criteria  and  targets  laid
down in Community legislation are being met by meat food business operators. These
official  controls  should  consist  of  audits  of  the  food  business  operators’  activities,
including good hygienic practices and hazard analysis and critical control point
(HACCP)-based procedures, and of inspection activities.

(11)  Official  controls  on  the  production  of  live  bivalve  molluscs  and  on  fishery  products
should be carried out to ascertain that the criteria and targets laid down in Community
legislation are being met. Official controls on the production of live bivalve molluscs
should among other things target relaying and production areas  for bivalve molluscs,
and the end-product.

(12)  Furthermore, official controls on the production of milk and milk products should be
carried out to ascertain that the criteria and targets laid down in Community legislation
are  being  met.  Official  controls  on  the  production  of  milk  and  milk  products  should
among  other  things  target  production  holdings,  raw  milk  upon  collection  and
processed milk products.

9

OJ L 273, 10.10.2002, p. 1.

8

                                                
(13) 

In order to ensure that products of animal origin imported into the Community
comply  with  Community  legislation  on  food  and  feed  and  in  particular
Regulation (EC) No 178/2002 of the European Parliament and of the Council of
28  January  200210,  or  conditions  recognised  by  the  Community  to  be  at  least
equivalent thereto, it is appropriate to lay down specific rules for the organisation
of official controls on imports of those products.

(14)  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
Commission11.  Since  the  measures  necessary  for  the  implementation  of  this
Regulation are measures of general scope within the meaning of Article 2 of Council
Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of
implementing powers conferred on the Commission, they should be adopted by use of
the regulatory procedure provided for in Article 5 of that Decision

(15) 

In accordance with the principle of proportionality, it is necessary and appropriate for
the  achievement  of  the  objectives  of  this  Regulation  to  lay  down  rules  on  technical
matters  related  to  official  controls.  This  Regulation  does  not  go  beyond  what  is
necessary  in  order  to  achieve  the  objectives  pursued  in  accordance  with  the  third
paragraph of Article 5 of the Treaty,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

Subject matter, scope and definitions

Article 1
Subject matter and scope

This  Regulation  lays  down  the  specific  rules  for  the  organisation  of  official  controls  of
products of animal origin intended for human consumption in order  to  supplement the  rules
laid down in Regulation (EC) No …/.. [of the European Parliament and of the Council of…
on official feed and food controls.]

It shall apply only in respect of official controls concerning the activities of food business
operators and persons to which Regulation (EC) No …/… [laying down specific hygiene
rules for food of animal origin] applies.

This  Regulation  shall  apply  without  prejudice  to  the  animal  health  rules  for  the
introduction of products of animal origin for human consumption laid down in Council
Directive 2002/99/EC.

10

11

OJ L 31, 1.2.2002, p. 31.
OJ L 184, 17.7.1999, p. 23.

9

                                                
Article 2
Definitions

1.

For  the  purposes  of  this  Regulation,  the  definitions  set  out  in  the  following
Regulations shall apply as appropriate:

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

(b) Regulation (EC) No …/… [on official feed and food controls],

(c) Regulation (EC) No …/… [on the hygiene of foodstuffs],

(d) Regulation  (EC)  No  …/…  [laying  down  specific  hygiene  rules  for  food  of

animal origin],

(e) Regulation (EC) No …/… 1774/2002.

2.

The following definitions shall also apply:

(a)

(b)

(c)

(d)

‘official  veterinarian’  means  a  veterinarian  qualified,  in  accordance  with
Article 8(1) to act in such a capacity and appointed by the competent authority.

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

‘official auxiliary’ means an officer qualified, in accordance with Article 8(1)
to  act  in  such  a  capacity,  appointed  by  the  competent  authority  and  working
under the authority and responsibility of an official veterinarian.

‘health  mark’  means  a  mark  applied  by  or  under  the  responsibility  of  the
official  veterinarian  indicating  that  the  rules  set  out  in  this  Regulation  have
been complied with.

CHAPTER II

OFFICIAL CONTROLS ON COMMUNITY ESTABLISHMENTS

Article 3
Approval of establishments

1.

Where Community or national legislation requires establishments to be approved, the
competent authority shall make an on-site visit.

The  competent  authority  shall  approve  establishments  only  if  it  has  been
demonstrated  that  they  meet  the  relevant  requirements  of  Regulations  (EC)  No
…/… [on food hygiene] and (EC) No. …/… [laying down specific hygiene rules
for food of animal origin] and other relevant requirements of food law.

10

In  establishments  starting  up  their  activities,  the  competent  authority  may  grant  a
conditional  approval  if  it  appears  from  an  on-site  visit  that  all  of  the  infrastructure
and equipment requirements provided for in this Regulation are complied with.

It  shall  grant  full  approval  only  if  it  appears  from  a  new  on-site  visit,  carried  out
within  three  months  from  the  date  of  the  conditional  approval,  that  the  other
requirements of relevant feed and food law are complied with.

Approved establishments shall be given an approval number to which codes shall be
added to indicate the types of products of animal origin manufactured.

For  wholesale  markets,  the  approval  number  may  be  completed  with  a  secondary
number  indicating  units  or  groups  of  units  selling  or  manufacturing  products  of
animal origin.

Member States shall maintain up-to-date lists of approved establishments with their
approval numbers.

Member States shall make such lists available to other Member States and the
public  in  a  manner  that  may  be  specified  in  accordance  with  the  procedure
referred to in Article 19(2).

2.

3.

Article 4
Fresh meat

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

Member  States  shall  ensure  that  official  controls  of  fresh  meat  shall  be  carried  out
inaccordance with Annex I. For that purpose,

1.            Official  veterinarians  and  official  auxiliaries  shall  be  qualified  and  undergo

training in accordance with Section IV of Chapter 2 of Annex I.

2.            The official veterinarian shall, in accordance with Section I.I.1 of Chapter 1 of
Annex I,  carry  out  auditing  tasks 
in  slaughterhouses,  game  handling
establishments,  and  in  cutting  plants  placing  fresh  meat  on  the  market,  in
particular as regards:

(a)     good hygienic practices;,

(b)     Hazard analysis and critical control points (HACCP)-based procedures.

3.            The official veterinarian shall, in accordance with Section I.I.2 of Chapter 1 of
Annex  I,  and  the  specific  requirements  of  Chapter  3  of  Annex  I,  carry  out
inspections  in  slaughterhouses,  game  handling  establishments,  and  in  cutting
plants placing fresh meat on the market, in particular as regards:

11

(a)     food chain information;

(b)     ante-mortem inspections;

(c)      animal welfare;

(d)     post-mortem inspections;

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

(f)      laboratory testing .

4.            The health marking of carcases 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.I.2 of Chapter 1 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.

5.            After having carried out the controls provided for in paragraphes 2 and 3, the
official  veterinarian  shall  take  the  appropriate  measures  in  accordance  with
Section I.2.H and Section II of Chapter 1 of Annex I, 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.

6.            Official  auxiliaries  may  assist  the  official  veterinarian  with  official  controls
carried out in accordance with Section I of Chapter 2 of Annex I. In that case,
the official auxiliaries shall work as part of an independent team.

7.            Member  States  shall  ensure  that  they  have  sufficient  staff  to  carry  out  the
official controls in accordance with Section I of Chapter I of Annex I and with
the frequency specified in Section II of Chapter 2 of that Annex.

8.            The  competent  authority  shall  follow  a  risk-based  approach  to  assess  the
number  of  staff  that  need  to  be  present  on  the  slaughter  line  in  any  given
slaughterhouse.

12

The  number  of  staff  involved  shall  be  sufficient  to  ensure  that  all  the
requirements of this Regulation are met.

9.            Member States  may  permit  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 poultry-meat, meat of lagomorphs,
fattening pigs and fattening veal in accordance with Section III of Chapter 2 of
Annex I.

10.          The  slaughterhouse  staff  carrying  out  the  tasks  referred  to  in  paragraph  9

must:

(a)     be  qualified  and  undergo  training  in  accordance  with  Section  IV.B  of

Chapter 2 of Annex I;

(b)     act independently from slaughterhouse staff involved in production; and

(c)      report any deficiency to the official veterinarian.

11.          Provisions  may  be  adopted  in  accordance  with  the  procedure  provided  for  in
Article 19(2) to permit Member States to extend the provisions of paragraph 9
to meat from other types of animals.

Article 5
Live bivalve molluscs

Official controls on the production and placing on the market of live bivalve molluscs,
live  echinoderms,  live  tunicates  and  live  marine  gastropods  shall  be  carried  out  in
accordance with Annex II.

Article 6
Fishery products 

Official controls on fishery products shall be carried out in accordance with Annex III .

Article 7
Raw milk and dairy products 

Official controls of raw milk and dairy products shall be carried out in accordance with
Annex IV.

13

CHAPTER III
IMPORTS

Article 8
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 a third country that appears on a list drawn up  and  updated  in accordance
with the procedure referred to in Article 19(2).

Such  lists  may  be  combined  with  other  lists  drawn  up  for  public  and  animal
health purposes.

2.            When drawing up or updating lists as provided for in paragraph 1, particular

account shall be taken of the following:

(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;

(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  resources  including  diagnostic  facilities  available  to  the  competent

authorities;

(d)     the training of staff in the performance of official controls;

(e)      the  extent  and  operation  of  official  controls  on  imports  of  animals  and

products of animal origin;

(f)      the results of official controls by the Community 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  such  official
controls;

14

(g)     the existence and operation of documented control procedures and control

systems based on priorities;

(h)     where  applicable,  the  situation  regarding  animal  health  and  procedures
for  notifying  the  Commission  and  relevant  international  bodies  of
outbreaks of animal diseases;

(i)      the  assurances  which  the  third  country  can  give  regarding  compliance

with Community rules or rules equivalent to Community rules;

(j)      the hygiene conditions of production, manufacture, handling, storage and
dispatch  actually  applied  to  products  of  animal  origin  destined  for  the
Community;

(k)     any experience of marketing of the product from the third country and the

results of any import controls carried out;

(l)

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

(m)    the existence, implementation and communication of an approved residue

control programme.

Article 9
List of establishments in third countries from which imports of specified products of animal
origin are permitted

1.            Products of  animal origin shall be  imported  only from  establishments  in  third
countries  that  appear  on  lists  drawn  up  and  updated  in  accordance  with  this
Article, except as provided for in paragraph 4.

2.            An establishment may be placed on a list provided for in paragraph 1 only if the

competent authority of the third country of origin guarantees that:

(a)     the establishment complies with:

(i)      relevant  Community  rules,  in  particular  those  provided  for  in
Regulation (EC) …/… [laying down specific hygiene rules for food of
animal origin]; or

(ii)     rules  that  were  determined  to  be  equivalent  to  such  rules  when
deciding to add that third country to the relevant list in accordance
with Article 8(1);

(b)     an official inspection service in the third country of  origin supervises  the

establishment; and

15

(c)      it  has  real  powers  to  stop  the  establishment  from  exporting  to  the
Community  in  the  event  that  the  establishment  fails  to  meet  the  rules
referred to in point (a).

3.            The competent authorities of third countries appearing on the lists provided for
in  Article 8(1)  shall  guarantee  that  lists  of  establishments  from  which  the
specified products of animal origin may be dispatched to the Community shall
be drawn up, kept up-to-date and communicated to the Commission.

4.            By  way  of  derogation  from  paragraph  1,  specified  products  of  animal  origin
may be imported from establishments not appearing on a list as provided for in
paragraph 1, in the following cases:

(a)     where  it  is  decided  on  a  case-by-case  basis  in  accordance  with  the
procedure referred to in Article 19(2), that the guarantees provided by the
third country in respect of imports of specified products of animal origin
are sufficient to ensure compliance with the requirements of paragraph 2;
and

(b)     in the cases listed in Annex V.

Article 10
Lists of production areas in third countries of live bivalve molluscs echinoderms, tunicates
and marine gastropods from which imports are permitted

1.            Live  bivalve  molluscs,  echinoderms,  tunicates  and  marine  gastropods  shall  be
imported  only  from  production  areas  in  third  countries  that  appear  on  lists
drawn up and updated in accordance with Article 9.

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, Section III.

3.            When drawing up the lists provided for in paragraph 1, particular account shall
be taken of the guarantees that the competent authority of the third country can
give concerning respect for the rules of this Regulation on the classification and
official control of production areas.

A Community inspection visit on-the-spot must take place before such lists are
drawn up unless:

(a)     the risk determined does not warrant it; and

16

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

Article 11
Lists of factory or freezer vessels and document to be signed by the captain of such vessels

1.            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 Article 9.

2.            When  fishery  products  are  imported  into  the  Community  directly  from  a
factory  or  freezer  vessel,  a  document  signed  by  the  captain  may  replace  the
document required under Article 15.

3.            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.

Article 12
Derogations from Article 11(2)

By way of derogation from Article 9(2), a factory or freezer vessel may be included on a
list referred to in Article 9,

1.            On the basis of a joint communication from the competent authority of the third
country  the  flag  of  which  the  vessel  is  flying  and  the  competent  authority  of
another  third  country  to  which  the  flag  third  country  has  delegated
responsibility for the inspection of the vessel subject to the following conditions:

(a)     the flag third country appears on the list of third countries,  drawn  up in
accordance  with  Article 8,  from  which  imports  of  fishery  products  are
permitted;

(b)     all  fishery  products  from  the  vessel  that  are  destined  for  placing  on  the
market in the Community are landed directly in the flag third country;

(c)      the competent authority of the flag third country has inspected the vessel

and declares that it complies with Community rules; and

(d)     the  competent  authority  of  the  flag  third  country  declares  that  it  will
regularly  inspect  the  vessel  to  ensure  that  it  continues  to  comply  with
Community rules.

17

2.            On the basis of a joint communication from the competent authority of the third
country  the flag of which the  vessel is  flying  and the  competent  authority  of  a
Member  State  to  which  the  flag  third  country  has  delegated  responsibility  for
the inspection of the vessel subject to the following conditions::

(a)     all  fishery  products  from  the  vessel  that  are  destined  for  placing  on  the
market in the Community are landed directly in that Member State;

(b)     the competent authority of that Member State has inspected the vessel and

declares that it complies with Community rules; and

(c)      the competent authority of that Member State shall regularly inspect the
vessel to ensure that it continually complies with Community rules.

3.            Detailed  rules  for  the  implementation  of  this  Articles  may  be  laid  down  in

accordance with the procedure referred to in Article 19(2).

Article 13
Notification of lists of establishments, production areas, and factory and freezer vessels
from which specified imports are permitted

1.            The  Commission  shall  provide  the  contact  points  designated  by  the  Member
States for  the  purpose of this Regulation with regular  notifications  concerning
new  or  updated  lists,  as  provided  for  in  Article  9(1),  Article  10(1)  and  Article
11(1), that  it has received from the  competent authorities of third  countries  in
accordance with Article 9(3).

If  no  Member  State  objects  to  those  new  or  updated  lists  within  five  working
days from the date of the Commission’s notification, imports shall be authorised
from  establishments  or  vessels  appearing  on  such  lists  ten  working  days  from
the date the Commission makes such lists publicly available.

2.            Where  following  the  notification  provided  for  in  paragraph  1  at  least  one
Member  State  makes  written  comments,  or  where  the  Commission  considers
that  the  amendment  of  a  list  is  necessary  in  the  light  of  relevant  information
such  as  Community  inspection  reports  or  a  notification  under  the  rapid  alert
system, it shall in inform all Member States and include the point on the 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).

18

Article 14
Up-to-date lists concerning imports

The Commission shall arrange for up-to-date versions of all lists provided for in Article
8(1), Article 9(1), Article 10(1) and Article 11(1) to be publicly available.

Article 15
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
…/… [on the hygiene of foodstuffs] and Regulation No …/… [laying down
specific  hygiene  rules  for  food  of  animal  origin]  or  provisions  that  are
equivalent to those requirements; and

(b)     any specific import conditions established in accordance with Article 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  established  in  accordance  with  the
procedure  referred  to  in  Article  19(2)  when  it  is  possible  to  obtain  the
guarantees referred to in paragraph 2 in another way.

CHAPTER IV
EMPOWERING PROVISIONS

Article 16
Flexibility

1.            Member States may adopt national rules adapting the rules laid down in Annex
I  provided  that  such  national  rules  do  not  compromise  the  objectives  of  this
Regulation and :

(a)     enable  the  continued  use  of  traditional  methods  at  any  of  the  stages  of

production, processing or distribution of food; or

19

(b)     accommodate the needs of food businesses:

(i)      with a small production rate; or

(ii)     situated in regions suffering from special geographic constraints.

2.            The national rules provided for  in  paragraph 1  shall concern in  particular the

following matters in Annex I:

(a)     food  chain  information  as  set  out  in  Section  I.2.A  of  Annex  I  and  in

Section II.B of Annex I; and

(b)     the presence of the competent authority depending on the risk analysis as

set out in Section II.2 of Chapter II of Annex I .

3.            Any  Member  State  wishing  to  adopt  national  rules  as  provided  for  in
paragraph 2  shall  notify  the  Commission  and  the  other  Member  States.  The
notification shall:

(a)     provide  a  detailed  description  of  the  rules  that  that  Member  State

considers need to be adapted and the nature of the proposed adaptation;

(b)     describe the establishments concerned;

(c)      explain  the  reasons  for  the  adaptation,  including,  where  relevant  a

summary of:

(i)      the hazard analysis carried out; and

(ii)     any  measures  to  be  taken  to  ensure  that  the  adaptation  does  not

compromise the objectives of this Regulation;

(d)     provide any other relevant information.

4.            The  other  Member  States  shall  have  three  months  from  the  date  of  receipt  of
the  notification  provided  for  in  paragraph 1  to  send  written  comments  to  the
Commission.

The  Commission  may,  and  if  it  receives  written  comments  from  one  or  more
Member States shall, consult the 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
if  necessary,  to  appropriate  amendments.  Where
implemented  subject, 
appropriate,  the Commission  may  propose  that  general  measures  having  the
objectives  set  out  in  paragraph  1  and  concerning  the  matters  set  out  in
paragraph  2  be  adopted  in  accordance  with with  the  procedure  referred  to  in
Article 19(2).

20

5.            A  Member  State  may  adopt  national  rules  adapting  the  requirements  of

Annex I only:

(a)     in compliance with a decision adopted in accordance with paragraph 4, or

(b)     if, one month after the expiry of the period of three months referred to in

paragraph 4, if the Commission has not informed the Member State that:

(i)      it has received written comments from other Member States; or

(ii)     it  intends  to  propose  the  adoption  of  a  decision  as  referred  to  in

subparagraph (a).

Article 17
Amendment of the Annexes, implementing rules and transitional measures

In  accordance  with  the  procedure  referred  to  in  Article 19(2)  and  where  necessary  after
having obtained the opinion of the European Food Safety Authority:

1.

2.

3.

Annexes I to IV shall may be amended or supplemented in order to take account of
scientific and technical progress;

Implementing rules needed to ensure uniform implementation of this Regulation shall
may be adopted;

Transitional measures may be laid down microbiological criteria for the control of
hygiene in production facilities may be laid down.

Article 18
Specific decisions

The implementing measures referred to in Article 17(2) may specify in particular:

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;

21

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,  depending  on
the  holding,  region  or  country  of  origin  and  based  on  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  co-operation  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.          Detailed rules for the implementation of Articles 11 and 12

15.          Organoleptic criteria for the evaluation of the freshness of fishery products;

16.          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;

22

17.          The  method  by  which  the  Commission  will  make  lists  of  third  countries  and
establishments in third countries available to the public pursuant to Articles 8,
9, 10 and 11;

18.          Models for documents and criteria for the use of electronic documents;

19.          Criteria  for  determining  the  risk  that  particular  products  of  animal  origin

imported into the Community present;

20.          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

21.          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
Regulatory procedure

1.

2.

3.

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.

Where  reference  is  made  to  this  paragraph,  the  regulatory  procedure  laid  down  in
Articles 5 and 7 of Decision 1999/468/EC shall apply, in compliance with Article 7
and having regard to the provisions of Article 8 thereof.

The  period  provided  for  in  Article 5(6)  of  Decision  1999/468/EC  shall  be
three months.

23

CHAPTER V
FINAL PROVISIONS

Article 20
Entry into force and applicability

This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.

It shall apply [insert dd/mm/yyyy]12.

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

Done at Brussels,

For the European Parliament
The President

For the Council
The President

12

This Regulation shall have the same date of application as the other legal texts that are part of the so-
called recast of hygiene legislation.

24

                                                
ANNEX I

FRESH MEAT

This Annex applies to slaughterhouses, game handling establishments and cutting plants.

Chapter 1
Type of controls and decisions following controls

I.

TASKS OF THE OFFICIAL VETERINARIAN

I.1 Audits of the official veterinarian

The  official  veterinarian  shall  carry  out  audits  in  meat  establishments  with  a
view  to  checking  whether  the  food  business  operator  complies  with  the
requirements  of  Regulation  (EC)  No  …/…  [on  the  hygiene  of  foodstuffs],
Regulation  (EC)  No  …/…  [laying  down  specific  hygiene  rules  for  food  of
animal  origin]  and  Regulation  (EC)  No  …/…  [laying  down  health  rules
concerning  animal  by-products  not  intended  for  human  consumption],  and
consequently  has  taken  all  appropriate  measures  to  ensure  good  hygienic
practices and safe meat. These audits include:

A. Audits of the good hygienic practices.

Such audits shall be carried out to verify the continuous compliance with
the food business operator’s own procedures concerning at least:

(a)

design and maintenance of plant structure and equipment;

(b)

plant  hygiene,  covering  pre-operational,  operational  and  post-
operational hygiene;

(c)

personal hygiene;

(d)

training in hygiene and in work procedures;

(e)

control of pests;

(f)

control of the water quality;

(g)

control of the temperature;

(h)

control of incoming and outgoing meat;

(i)

handling, collection, transport, and storage, handling, processing
and use or disposal of animal by-products not intended for human
consumption,  including  Specified  Risk  Materials,  for  which  the
food business operator is responsible.

25

B.

Audits of the procedures based on  the principles of hazard analysis  and
critical control points (HACCP).

Such audits shall be carried out to verify whether all HACCP-principles
are  continuously  and  properly  applied  and  whether  the  HACCP-based
procedures guarantee:

1.

that the animals entering the slaughter process:

(a)

are properly identified;

(b)

(c)

are  accompanied  by  the  relevant  information  from  the
holding of provenance of the animals;

have hide, skin or fleece conditions that are such that the risk
of  contamination  of  the  meat  during  slaughter  is  kept  to  a
minimum;

(d)

are visually healthy;

(e)

have  been  transported  and  handled  in  a  manner  which
complies with Community animal welfare rules.

2.

to  the  extent  possible,  that  the  meat  at  the  end  of  the  slaughter
process:

(a)

(b)

(c)

(d)

is  in  conformity  with  the  microbiological  criteria  laid  down
in Community legislation, including hygiene parameters  and
the relevant criteria for pathogens;

does not contain chemical residues in excess of the levels laid
down in Community legislation;

does  not  contain  residues  of  substances  forbidden 
Community legislation;

in

does  not  contain  contaminants  in  excess  of  the  levels  laid
down in Community legislation;

(e)

does not display physical hazards, such as foreign bodies;

(f)

does  not  contain  patho-physiological  abnormalities  or
the  official
changes,  by  bringing 
veterinarian  carcases  or  meat  containing  such  abnormalities
or changes;

the  attention  of 

to 

(g)

does not bear faecal or other contamination;

26

(h)

(i)

does not contain Specified Risk Material, except as provided
for  under  Community  legislation,  and  has  been  produced  in
accordance  with  the  relevant  Community  legislation  on
transmissible spongiform encephalopathies;

is 
in  conformity  with 
concerning traceability of meat.

the  relevant  Community  rules

C. Audits of the use of guides.

Where the food business operator uses Community or national guides on
good practices in order to comply with Community or national rules, the
correct use of such guides shall be audited.

D.

Performance of audits.

Special care shall be taken in carrying out the audits provided for in this
Chapter in regard to:

(a)

keeping an oversight of the activities carried out by the staff of the
establishment  on  an  on-going  basis,  and  at  all  stages  of  the
slaughtering and cutting process; the official veterinarian may carry
out performance tests in order to ascertain that the performance of
the  staff  of  the  establishment  meets  specific  criteria  set  by  the
competent  authority;  detailed  rules  concerning  the  performance
tests  shall  be  adopted  if  necessary,  in  accordance  with  the
procedure referred to in Article 19(2);

(b)

verification  of  all  the  relevant  records  of  the  food  business
operator;

(c)

taking samples for laboratory analysis whenever deemed necessary;

(d)

documenting  the  elements  taken  into  account  and  the  findings  of
the audit.

I.2

Inspections to be carried out by the official veterinarian

The  results  of  the  audits  carried  out  under  Section  I.1  shall  be  taken  into
account  by  the  official  veterinarian  in  carrying  out  his  inspections  and  shall
affect, where appropriate, the way those inspections are carried out.

Those inspections shall include:

27

A.

Food chain information

1.

The relevant information contained in the records of the holding of
provenance  of  the  animals,  which  shall  be  made  available  by  the
operator  of  the  holding  in  accordance  with  Regulation  (EC)
No …/…  [on  the  hygiene  of  foodstuffs],  shall  be  checked  and
analysed  by  the  official  veterinarian  before  slaughter  of  the
animals. This information shall cover at least:

(a)

the status of the holding of provenance or the regional animal
health status;

(b)

the animals’ health status;

(c)

(d)

(e)

the  details  of  veterinary  medicinal  products  or  other
treatments  administered  to  the  animals  during  the  rearing
period  (with  a  maximum  period  of  the  previous  six  months
before  the  date  of  the  inspection),  date(s)  of  administration
and the withdrawal period(s). Details shall only be given for
veterinary  medicinal  products  with  a  withdrawal  period
of  more  than  zero  or  for  veterinary  medicinal  products
that  may  have  an  effect  on  the  detection  of  animal
diseases;

the occurrence of diseases which have occurred and which
may affect the safety of the meat;

the results, if they are relevant to the protection of public
health, of any analysis carried out on samples taken from the
animals  or  other  samples  taken  to  diagnose  diseases  that
may  affect  the  safety  of  the  meat  for  diagnostic  purposes,
including samples taken in the framework  of  the  monitoring
and control of zoonoses and residues;

(f)

the  relevant  reports  from  slaughterhouses  about  previous
ante-  and  post-mortem  findings  in  animals  from  the  same
holding of provenance;

(g)

the relevant production data;

(h)

(i)

the  name  and  address  of  the  private  veterinarian  normally
attending the operator of the holding of provenance; and

the  name  of  the  responsible  official  veterinarian/veterinary
office.

28

2.

3.

4.

Detailed  rules  concerning  the  way  this  information  shall  be
established, and the way this information shall  be  presented,  shall
be  laid  down  in  accordance  with  the  procedure  of  Article  6.  The
following shall be laid down in accordance with the procedure
referred to in Article 19(2):

(a)     rules concerning the way food chain information shall be

established and proposed;

(b)     the  form  of  a  standard  declaration  on  food  chain

information, to be signed by primary producers.

In  carrying  out  ante-  and  post-mortem  inspection,  the  official
veterinarian  shall  take  into  account  the  documented  results  of  the
check and analysis of food chain information.

In  carrying  out  his  inspections,  the  official  veterinarian  shall  take
into  account  official  certificates  accompanying  the  animals,  and
possible  declarations  of  veterinarians  carrying  out  controls  at  the
level  of  primary  production,  including  official  veterinarians  and
approved  veterinarians  taking  part  in  a  surveillance  network
system, as provided for by Article 14 of Directive 64/432/EEC1.

5. When the food business operators in the food chain take additional
measures  to  guarantee  food  safety  by  implementing  integrated
systems,  private  control  systems, 
third  party
certification  or  by  other  means,  and  when  such  measures  are
documented  and  the  animals  covered  by  those  schemes  clearly
identifiable, the official veterinarian may take them into account in
carrying  out  his  inspections  and  in  reviewing  the  HACCP-based
procedures.

independent 

B.

Ante-mortem inspection (the following rules do not apply to hunted wild
game).

1.

Before  slaughter,  all  animals  must  undergo  an  ante-mortem
inspection  by  the  official  veterinarian.  The  animals  must  undergo
the
ante-mortem 
slaughterhouse and less than 24 hours before slaughter. In addition,
the official veterinarian may require inspection at any other time.

inspection  within  24 hours  of  arrival  at 

1

OJ P 121, 29.7.1964, p. 1977.

29

                                                
2.

The inspection must determine, in particular, whether:

(a)

animal identification rules have been complied with;

(b)

the welfare of the animals is not compromised;

(c)

(d)

hide,  skin  or  fleece  conditions  are  such  that  the  risk  of
contamination  of  the  meat  during  slaughter  is  kept  to  a
minimum;

signs  of  any  condition  which  might  adversely  affect  human
or animal health are present, with particular attention for the
detection of zoonotic diseases, diseases listed on List A of the
Office International des Epizooties (OIE) and other notifiable
diseases.

3.

The official veterinarian shall, at the slaughterhouse, also carry out
a clinical inspection of all animals  that  the  food  business operator
or  official  auxiliaries  may  have  put  aside  as  being  unfit  for
slaughter.

4. Where  provided  for  in  this  Regulation,  part  of  the  ante-mortem
inspection may be carried out at the holding  of  provenance of  the
animals.

5.

In  case  of  emergency  slaughter  outside  the  slaughterhouse,  the
official  veterinarian  in  the  slaughterhouse  shall  examine  the
in  accordance  with
the  veterinarian, 
certificate, 
Regulation (EC) No …/… [laying down specific hygiene rules for
food of animal origin].

issued  by 

C. Animal welfare

The  official  veterinarian  shall  verify  compliance  with  the  relevant
Community and national rules on the welfare of animals, including the
rules concerning the protection of animals at the time of slaughter and the
rules concerning the protection of animals during transport.

D.

Post-mortem inspection

1.

The  carcase  and  accompanying  offal  shall  be  subjected  without
delay to visual post-mortem inspection. All external surfaces shall
be  viewed;  minimal  handling  of  the  carcase  and/or  offal,  and/or
special  technical  facilities  may  be  required  for  that  purpose.
Particular  attention  shall  be  paid  to  the  detection  of  zoonotic
diseases,  diseases  listed  on  List A  of  the  OIE  and  other  notifiable
diseases.  The  speed  of  the  slaughterline  and  inspection  staffing
level shall be such as to allow for proper inspection. Depending on
the animal species, the type of holding or the country or region of
origin,  and  based  on  the  principles  of  risk  analysis,  additional
palpation, incisions or laboratory tests are required as referred to in
Chapter 3.

30

2. Whenever considered necessary to reach a definitive  diagnosis, or
to detect the presence of an animal disease or an excess of chemical
residues  or  non-compliance  with  microbiological  criteria,
additional  examination  shall  take  place,  such  as  palpation  and
incision of parts of the carcase and offal, and laboratory tests.

3.

4.

5.

Carcases of domestic solipeds, bovine animals over six months old,
and  domestic  swine  over  four  weeks  old  shall  be  submitted  for
post-mortem  inspection  split  lengthways  into  half  carcases  down
the  spinal  column.  If  the  inspection  so  necessitates,  the  official
veterinarian  may  require  any  head  or  any  carcase  to  be  split
technological
lengthways.  However, 
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.

take  account  of 

to 

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.

Alternative  procedures,  serological  or  other  laboratory  tests  may,
after  consultation  of  the  European  Food  Safety  Authority  and
following  the  procedure  referred  to  in  Article  19(2),  replace
specific post-mortem inspection procedures referred to in Chapter 3
when  they  provide  at  least  equivalent  guarantees.  The  competent
authority  shall  be  in  agreement  with  the  use  of  those
procedures.

6.       In  the  case  of  emergency  slaughter,  the  carcase  shall  be
subjected  as  soon  as  possible  to  a  post-mortem  inspection,  in
accordance  with  points  1  to  5,  before  being  declared  fit  for
human consumption.

E.

Specified Risk Materials (SRMs)

In accordance with the specific Community rules on SRMs the removal,
separation,  staining  and,  where  appropriate,  marking  of  SRMs  shall  be
checked  by  the  official  veterinarian.  He  shall  ensure  that  the  food
business  operator 
to  avoid
contamination  of  the  meat  with  SRM  during  slaughter  (including
stunning) and removal of SRM.

the  necessary  measures 

takes  all 

31

F.

Laboratory testing and base-line studies on pathogens

1.

In the framework of:

(a)

(b)

(c)

(d)

(e)

official  monitoring  for  zoonoses,  including  Salmonella  spp.,
Campylobacter  spp.,  verotoxin  producing  Escherichia  coli
and multi-resistant bacterial strains;

testing 

transmissible
laboratory 
spongiform encephalopathies as provided for in Article 20(1)
of Regulation (EC) No 999/20012;

the  diagnosis  of 

for 

the  detection  of  unauthorised  substances  or  products,  the
control  on  regulated  substances  and  in  particular  in  the
framework  of  the  monitoring  plans  for  the  detection  of
residues  or  substances  as  provided  for  in  Chapter  II  of
Directive 96/23/EC3;

the detection of zoonotic diseases, diseases listed on List A of
the OIE and other notifiable diseases;

laboratory  testing  of  animals  considered  suspect  by  the
official  veterinarian,  or  laboratory  testing  for  the  official
veterinarian to reach a definitive diagnosis;

the official veterinarian shall carry out the sampling and ensure the
samples  are  identified,  handled  and  sent  to  the  appropriate
laboratory in accordance with the relevant specifications and taking
into consideration other Community rules laid down in the fields of
zoonoses, transmissible spongiform encephalopathies and residues.

2. Where necessary, detailed rules for laboratory testing shall be laid
down in accordance with the procedure referred to in Article 19(2).
including  specific  rules  for  base-line  studies  on  Salmonella  spp.,
Campylobacter  spp.,  verotoxin  producing  Escherichia  coli  and
multi-resistant bacterial strains.

G. Health and identification marking

1. Meat  of  domestic  ungulates,  farmed  game  mammals  other  than
lagomorphs and large wild game shall be health marked under the
responsibility  of  the  official  veterinarian.  After  completion  of  the
post-mortem  inspection,  carcases,  half  carcases,  quarters  and
carcases cut into three pieces must be health-marked by stamping the
mark in ink or hot-branding the mark on the external surface so as to
ensure that the number of the establishment is easily identifiable.

2

3

OJ L 147, 31.5.2001, p. 1.
OJ L 125, 23.5.1996, p. 10.

32

                                                
2.

For  the  purposes  of  health  and  identification  marking,  the  official
veterinarian shall supervise:

(a)

the health marking;

(b)

the  marks  and  wrapping  material  when  marked  as  provided
for in this section.

3.

Except for hunted wild game, the health mark may only be applied
when the animal (from which the meat has been obtained) has been
inspected ante-mortem by the official veterinarian and when all the
other requirements of this Regulation have been met. However, the
health  mark  may  be  applied  before  the  results  of  any
examination 
the  official
veterinarian is satisfied that meat from the animal concerned is
to be placed on the market only if the results are satisfactory.

is  available, 

trichinosis 

for 

if 

4.

The health mark must be:

(a)

either  an  oval  mark  at  least  6,5 cm  wide  by  4,5 cm  high
bearing 
legible
characters:

the  following 

in  perfectly 

information 

(i)

on the upper part, the initials of the consigning country
in capitals: B - DK - D - EL - E - F - IRL - I - L - NL –
A  -  P  -FIN  -  S  -  UK,  followed  by  the  veterinary
approval number of the establishment;

(ii)

on the lower part, one of the  following sets of  initials:
CE, EC, EF, EG, EK, or EY;

(b)

or an oval mark at least 6,5 cm wide by 4,5 cm high, bearing
the following information in perfectly legible characters:

(i)

(ii)

on  the  upper  part,  the  name  of  the  consigning  country
in capitals;

in  the  centre,  the  veterinary  approval  number  of  the
establishment;

(iii) on the lower part, one of the following sets of initials:

CE, EC, EF, EG, EK, EY.

The  letters  must  be  at  least  0,8 cm  high  and  the  figures  at  least
1 cm high. The health mark may, in addition, include an indication
of the official veterinarian who carried out the health inspection of
the  meat.  The  dimensions  and  characters  of  the  mark  may  be
reduced for health marking of lamb, kids and piglets.

33

5.

Carcases must be stamped in ink or hot-branded in accordance with
point 4:

(a)

(b)

(c)

those  weighing  more  than  65 kilograms  must  be  marked  on
each  half-carcase,  in  the  following  places  at  least:  external
surface of the thighs, loins, back, breast and shoulder;

lamb, kid and piglet  carcases must  bear at least two stamps,
one  on  each  side  of  the  carcase,  on  the  shoulder  or  on  the
external surface of the thighs;

other carcases must be marked in at least four places, on the
shoulder and on the external surface of the thighs. However,
in  the  case  of  lamb,  kid  and  piglet  carcases,  health  marking
may take the form of a label or tag which may be used only
once.

The  livers  of  bovine  animals,  swine  and  solipeds  must  be  hot-
branded in accordance with point 4.

All  other  sub-products  of  slaughtering  fit  for  human  consumption
must  be  marked  immediately  in  accordance  with  point 4,  either
directly on the product or on the wrapping or packaging. The mark
in accordance  with point 4  must be applied to  a  label  fixed  to  the
wrapping or packaging or printed on the packaging.

Packaging must always be marked in accordance with point 9.

Packaged  cut  meat  and  packaged  offal  referred  to  in  point 6  and
point 7  must  bear  a  health  mark  in  accordance  with  point 4.  The
mark must be applied to a label  fixed to the packaging, or printed
on  the  packaging,  in  such  a  way  that  it  is  destroyed  when  the
packaging  is  opened.  Non-destruction  of  the  mark  must  be
tolerated  only  when  the  packaging  is  destroyed  by  being  opened.
However,  when  wrapping  fulfils  all  the  protective  conditions  of
packaging, the label may be affixed to the wrapping.

6.

7.

8.

9.

10. Where fresh meat is wrapped in commercial portions intended  for
direct  sale  to  the  consumer,  points 7  and  9  shall  apply.  The
dimension  requirements  of  point 4  need  not  apply  to  the  mark
required  under  this  point.  If  meat  is  re-packaged  in  a  plant  other
than that in which it was first wrapped, the wrapping must bear the
health mark of the cutting plant where it was first wrapped, and the
packaging must bear the health mark of the packaging centre.

11. Meat from solipeds and its packaging must bear a special mark, to
be  determined  in  accordance  with  the  procedure  laid  down  in
Article 19(2).

34

12. The  colours  used  for  health  marking  must  be  those  listed  in  the
relevant Community legislation on colours for use in foodstuffs.

13. Health marks may not be removed unless the meat is further worked
upon in another separate approved establishment where the original
mark  must  be  replaced  by  a  mark  with  that  establishment’s  own
number.

H.

Communication of inspection results

1.

The official veterinarian shall record and evaluate the results of his
inspections.  If  his  inspection  has  revealed  the  presence  of  any
disease or condition which might affect public or animal health, or
compromised  animal  welfare, 
shall  be
communicated to:

information 

this 

(a)

the food business operator of the meat establishment;

(b) When  the  problem  arises  during  primary  production,  this
information shall also the competent authority responsible for
supervising  the  holding  of  provenance  of  the  animals  or  the
hunting area;

(c)

the private veterinarian attending the holding of provenance;
and

(d)

the person responsible for the holding of provenance.

However, where it is the necessary to find evidence of non-respect
of  good  veterinary  practice  or  for  illegal  use  of  pharmaceutical
substances,  the  official  findings  shall  not  be  communicated  to  the
private veterinarian and the person responsible for the holding.

The  official  veterinarian  may  decide  not  to  communicate
certain information if it is  not relevant to  a particular  person.
Following  such  communication,  action  must  be  taken  by  the
persons responsible in their sphere of competence for the holding
of provenance, to remedy the situation where appropriate.

2.

The  results  of  inspections  and  tests  shall  be  communicated  to  the
relevant databases.

3. Where the animals concerned were raised in another Member State
or  in  a  third  country,  the  finding  of  a  disease  or  condition  which
might  affect  public  or  animal  health,  or  compromised  animal
welfare, shall be communicated to the food business operator of the
meat  establishment  and  to  the  central  competent  authority  of  the
Member  State  where  the  meat  establishment  is  located.  The  meat
establishment  shall  inform  the  Commission  in  cases  where  the
animals concerned were raised in a third country.

35

4. When  the  official  veterinarian,  while  carrying  out  ante-  or  post-
mortem  inspection  or  any  other  inspection  activity,  suspects  the
presence of an infectious agent listed in List A of the OIE, he shall
immediately  notify  the  central  competent  authority.  He  shall  take
all  necessary  measures  and  precautions  to  prevent  the  possible
spread  of  the  infectious  agent  including  the  shut-down  of  the
establishment,  with  no  further  movements  either  on  or  off  the
premises, until either the absence of the agent has been confirmed
or  all  the  necessary  restrictions  and  measures  have  been  put  in
place.

5.

Detailed rules concerning the communication of inspection  results
shall  be  adopted  if  necessary,  in  accordance  with  the  procedure
referred to in Article 19(2).

II.

DECISIONS FOLLOWING OFFICIAL CONTROLS

Where, following official controls, deficiencies, non-compliance or irregularities are
found, appropriate measures shall be taken including:

A. Decisions  following  audits  of  the  good  hygienic  practices  and  the  HACCP-

based procedures

1. When  an  audit  of  the  good  hygienic  practices  or  the  HACCP-based
procedures reveals non-compliance, the official veterinarian shall ensure
that the food business operator immediately reviews the process controls,
discovers the cause if possible, rectifies the non-compliance and prevents
recurrence.  Depending  on  the  nature  of  the  problem,  measures  such  as
slowing down the process, may be taken by the official veterinarian.

2. Whenever the audit of the good hygienic practices or the HACCP-based
procedures or other investigations reveal that meat may be placed on the
market  that  is  unfit  for  human  consumption  under  the  provisions  of
Section  II.E,  and  the  food  business  operator  fails  to  adapt  immediately
the procedures, the slaughtering or cutting process shall be stopped. The
process shall only resume  when the official veterinarian is satisfied  that
the  situation  is  under  control.  A  similar  procedure  shall,  whenever
considered  necessary  by  the  official  veterinarian,  also  apply  when  non-
compliance occurs repeatedly.

3. Where  appropriate,  the  official  veterinarian  shall  order  a  recall,  further
examination and, when necessary, withdrawal and/or destruction of meat.

4. When  the  process  has  to  be  stopped  repeatedly,  and  the  food  business
operator is not able to prevent a recurrence, the competent authority shall
start the procedure for withdrawal of the approval of the establishment.

36

B.

Decisions concerning the food chain information

1.

Animals  without  the  relevant  food  safety  information  contained  in  the
records of the holding of provenance of the animals shall not be accepted
the
for  slaughter.  When 
slaughterhouse,  they  shall,  without  prejudice  to  the  specific  legislation
governing  veterinary  checks  in  intra-Community  trade,  be  killed
separately and declared unfit for human consumption.

those  animals  are  already  present  at 

2. When there are overriding animal welfare considerations the animal may
be slaughtered even if the food chain information has not been supplied;
however,  all  food  chain  information  needed  by  the  official  veterinarian
for  an  appropriate  post-mortem  inspection  shall  be  supplied  before  the
carcase  may  be  approved  for  human  consumption.  Pending  a  final
judgement, such a carcase and the related offal shall be stored separately
from the other meat. This provision shall also apply in case of emergency
slaughter outside the slaughterhouse.

3. When  the  accompanying  records,  documentation  and  other  information

show that:

(a)

(b)

(c)

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

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

any other condition which might adversely affect human or animal
health is present;

the  animals  shall  not  be  accepted  for  slaughter  unless  procedures  are
followed that have been introduced under Community rules to eliminate
human or animal health risks. If those animals are already present at the
slaughterhouse,  they  shall  be  killed  separately  and  declared  unfit  for
human  consumption,  and  precautions  taken  to  safeguard  animal  and
public health where appropriate.  Whenever  considered necessary by  the
official veterinarian, official controls shall be carried out on the holding
of provenance.

4. When the competent authority discovers that the accompanying records,
documentation  and  other  information  do  not  correspond  with  the  true
situation  on  the  holding  of  provenance  or  the  true  condition  of  the
animals or aimed at deliberately misleading the official veterinarian, the
competent authority shall take action against  the food business operator
responsible  for  the  holding  of  provenance  of  the  animals,  or  any  other
person  involved.  This  may  consist  in  particular  of  extra  controls.  The
costs of such extra controls shall be borne by the food business operator
of the holding of provenance or the other persons involved.

37

C. Decisions concerning live animals

1.

Animals not properly identified shall not be accepted for slaughter. Those
animals  shall  be  killed  separately  and  declared  unfit  for  human
the  official
consumption.  Whenever  considered  necessary  by 
veterinarian,  official  controls  shall  be  carried  out  on  the  holding  of
provenance.

2. When there are overriding animal welfare considerations, horses may be
slaughtered  even  if  the  legally  required  information  concerning  the
identity  has  not  been  supplied;  however,  such  information  shall  be
supplied  before  the  carcase  may  be  approved  for  human  consumption.
This  provision  shall  also  apply  in  the  case  of  emergency  slaughter  of
horses outside the slaughterhouse.

3.

4.

5.

6.

7.

Animals  that  have  such  hide,  skin  or  fleece  conditions  that  there  is  an
increased risk of contamination of the meat during slaughter shall not be
slaughtered for human consumption.

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

The  slaughter  of  animals  suspected  of  having  a  disease  or  condition
which  may  adversely  affect  human  or  animal  health,  shall  be  deferred.
Those  animals  shall  undergo  detailed  examination  in  order  to  make  a
diagnosis. Where post-mortem inspection is necessary in order to make a
diagnosis  the  official  veterinarian  may  decide  that  the  animals  must
undergo  a  post-mortem  inspection  supplemented,  if  necessary,  by
sampling and laboratory examinations. The animals shall be slaughtered
separately or at the end of the normal slaughtering, taking  all necessary
precautions to avoid possible contamination of other meat.

In the case of animals which might have residues of veterinary medicinal
products in excess of the levels laid down in Community legislation, or
residues  of  substances  prohibited  under  Community  legislation,  the
measures provided for in Chapter V of Directive 96/23/EC shall be taken.

The  slaughter  treatment  of  animals  under  a  specific  scheme  for  the
eradication  or  control  of  a  specific  disease  including  brucellosis  or
tuberculosis  or  other  zoonotic  agents  shall  be  carried  out  under  the
conditions  imposed  by,  and  the  direct  supervision  of,  the  official
veterinarian;  the  competent  authority  shall  determine  the  measures
and conditions under which those animals are to be slaughtered. The
animals  must  be  slaughtered  under  conditions  such  that  other  animals
and/or the meat of other animals cannot be contaminated.

38

8.

Once  animals  have  arrived  within  the  perimeter  of  slaughterhouse
premises, they shall not leave those premises alive except in the case of a
serious  breakdown  of  the  slaughter  facilities.  In  those  circumstances,
only direct movements to another slaughterhouse shall be allowed.

D. 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 shall ensure
that  the  food  business  operator  immediately  takes  the  necessary
corrective  measures  and  prevents  any  recurrence.  Depending  on  the
nature  of  the  breach,  measures  such  as  slowing  down  or  stopping  the
slaughter  process,  may  be  taken  by  the  official  veterinarian.  Where
appropriate,  the  official  veterinarian  shall  inform  other  competent
authorities.

2. When  the  official  veterinarian  discovers  that  rules  concerning  the
protection  of  animals  during  transport  are  not  being  respected,  he  shall
take the necessary measures in accordance with the relevant Community
legislation.

E.

Decisions concerning meat

The following meat shall be declared unfit for human consumption:

(a) meat  from  animals  which  have  not  undergone  ante-mortem  inspection,

except for hunted wild game;

(b) meat  from  animals  the  offal  of  which  has  not  undergone  post-mortem
inspection,  unless  otherwise  provided  for  under  this  Regulation  or
Regulation  (EC)  No.  …/…  [laying  down  specific  rules  for  food  of
animal origin];

(c) meat from animals which are dead before slaughter, stillborn, unborn or

slaughtered under the age of 7 days;

(d) meat resulting from the trimming of the sticking points;

(e) meat from animals affected by an OIE list A or, where appropriate, OIE

list B disease, unless otherwise provided for in Chapter 3;

(f) meat from animals affected by generalised disease, septicaemia, pyaemia,

toxaemia or viraemia;

(g) meat that is not in conformity with  the  relevant  microbiological  criteria

laid down in Community legislation;

(h) meat found to exhibit parasitic infestation, unless otherwise provided for

in Chapter 3;

39

(i) meat  containing  residues  or  contaminants  in  excess  of  the  levels  laid
down  in  Community  legislation.  Such  excess  shall  lead  to  additional
analyses whenever appropriate;

(j) without  prejudice  to  more  specific  Community  legislation,  meat  from
animals  or  carcases  containing  residues  of  substances  prohibited  under
Community legislation and all meat from animals that have been treated
with such substances;

(k)

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

(l) meat that has been treated illegally with decontaminating substances;

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

(n) meat  containing  foreign  bodies,  except  in  the  case  of  wild-game  meat

where it concerns material used to hunt the animal;

(o) meat  exceeding the  maximum permitted radioactive  levels laid down in

Community legislation;

(p) meat  with  patho-physiological  changes,  anomalies  in  consistency,
in  particular  a

insufficient  bleeding,  organoleptic  anomalies, 
pronounced sexual odour, or from emaciated animals;

(q) meat  containing  Specified  Risk  Material  except  as  provided  for  under

Community legislation;

(r) meat showing soiling, faecal or other contamination;

(s)

(t)

the blood of an animal whose carcase has been declared unfit for human
consumption  in  accordance  with  the  points  (a)  to  (r),  and  blood
contaminated by stomach contents or any other substance;

all meat that, in the opinion of the official veterinarian, after examination
of all the relevant information, may constitute a public or  animal health
danger or is for any other reasons not suitable for human consumption.

40

Chapter 2
Responsibilities and frequency of official controls

I.

THE INSPECTION TEAM

In  carrying  out  the  official  controls,  the  official  veterinarian  may  be  assisted  by
official  auxiliaries  placed  under  his  authority  and  responsibility.  The  official
auxiliaries may carry out the following activities:

(a)

(b)

collecting  information  regarding  good  hygienic  practices  and  the  HACCP-
based procedures;

helping with ante-mortem inspections in the slaughterhouse or at the holding
of  provenance.  In  that  case  the  official  auxiliary’s  role  shall  be  to  make  an
initial check on the animals and to help with purely practical tasks;

(c)

checks concerning the welfare of animals;

(d)

(e)

post-mortem  inspections,  provided  that  the official veterinarian is  supervising
the work of the official auxiliaries;

checks on the removal, separation, staining and, where appropriate, marking of
Specified Risk Material;

(f)

checks on cut and stored meat;

(g)

sampling; and

(h)

inspection and supervision of establishments, means of transport.

II.

THE FREQUENCY OF OFFICIAL CONTROLS

1.

The competent authority shall guarantee appropriate official supervision inmeat
establishments.  The  nature  and  intensity  of  the  official  supervision  shall  be
based on a regular assessment of the public and animal health risks, the animal
welfare  aspects  and  the  product  suitability  aspects  related  to  the  species  and
category  of  animals  slaughtered,  the  type  of  process  and  the  food  business
operator  concerned.  In  the  calculation  of  staffing  on  the  slaughterline,  a
scientific approach shall be followed where appropriate. The number of official
staff involved shall be such that all the requirements of this Regulation may be
applied.

41

2.

Care  shall  be  taken  to  ensure  that  in  slaughterhouses  and  game  handling
establishments, at least one official veterinarian is present throughout both the
ante-mortem  and  the  post-mortem  inspection  and  in  game  handling
establishments throughout post-mortem inspection.

Some  flexibility  may  be  applied  for  small  slaughterhouses  and  small  game
handling  establishments:  The  competent  authority  may  exercise  a  more
flexible approach  in slaughterhouses with a low  throughput  and  in  game
handling establishments identified on the basis of risk analysis as follows:

(i)

(ii)

ante-mortem  inspection  shall  be  carried  out  by  the  official  veterinarian,
but may take place at the holding of provenance;

the  permanent  presence  of  the  official  veterinarian  during  post-mortem
inspection is not required, provided that  an official auxiliary  carries  out
post-mortem  inspection,  and  that  meat  with  abnormalities  is  put  aside
and inspected by  the  official  veterinarian;  a  documented  control  system
shall  be  put  in  place  that  allows  the  official  veterinarian  to  be  satisfied
that standards are being met.

When  necessary  to  ensure  the  uniform  implementation  a  definition  of
slaughterhouse  with  a small throughput  shall  be  approved  in accordance  with
the procedure defined in Article 19(2).

3.

In the case of poultry, the flexible approach provided for in point 2 may, on the
basis  of  a  case-by-case  analysis  of  the  risks  by  the  competent  authority,  be
applied in other slaughterhouses than small ones.

4.

The flexible approach provided for in points 2 and 3 shall not apply:

(i)

(ii)

(iii)

(iv)

for  emergency  slaughtered  animals  and  animals  suspected  of  having  a
disease or condition which may adversely affect human health;

for  bovine  animals  coming  from  herds  that  have  not  been  declared
officially tuberculosis-free;

for  bovine  animals,  sheep  and  goats  coming  from  herds  that  have  not
been declared officially brucellosis-free;

in case of an outbreak of a disease listed on List A or, where appropriate,
List B of the OIE this provision shall apply to animals susceptible to the
particular  disease  in  question  and  coming  from  the  particular  region  as
defined in Article 2 of Directive 64/432/EEC;

(v) when  considered  necessary,  to  take  into  account  emerging  diseases  or

certain List B diseases.

42

5.

Care shall be taken in cutting plants to ensure that a member of the inspection
team is regularly present, but at least once a week, when meat is being worked
on in accordance with an inspection schedule drawn up by the competent
authority on the basis of a risk analysis.

III.

INVOLVEMENT OF SLAUGHTHERHOUSE STAFF

1. Member States  may allow staff  of  the  establishment  to  carry  out  activities  of
official auxiliaries in the control on the production of poultry  and rabbit meat
under the following conditions:

(a) Where  the  establishment  has  successfully  been  operating,  for  at  least
12 months,  good  hygienic  practices  and  HACCP-based  procedures,  the
competent  authority  may  permit  staff  of  the  establishment,  having
received  a  training  equivalent  to  the  training  of  official  auxiliaries,  and
having  passed  the  same  test,  to  carry  out  tasks  of  official  auxiliaries
under the supervision of the official veterinarian.

In that case, the official veterinarian shall be present throughout ante- and
post-mortem  inspection,  shall  supervise  those  activities  and  carry  out
regular performance tests to ascertain that the performance of the staff of
the establishment meets specific  criteria set by  the  competent  authority,
and  shall  document  the  results  of  those  performance  tests.  When
necessary,  detailed  rules  concerning  the  performance  tests  shall  be
adopted in accordance with the procedure referred to in Article 19(2).

However,  when  the level of hygiene  in the  establishment  decreases  due
to the functioning of the staff, or when tasks are not properly carried out
by the staff, or, in general, when the staff carries out their activities in a
manner that is not satisfactory according to the competent authority, they
shall be replaced by official auxiliaries.

(b) The  competent  authority  of  the  Member  State  shall  decide  in  principle
and on a case by case basis whether  to  allow  for the implementation of
the system provided for in point (a).If the Member State decides to do so
in  principle,  it  should  inform  the  Commission  of  its  decision  and  the
conditions thereof.

For  meat  establishments  in  a  Member  State  where  that  system  is
implemented,  the  actual  use  of  the  system  shall  be  optional.  Meat
establishments  shall  not  be  forced  by  the  competent  authority  to
introduce the system.

the  competent  authority 

When 
the  meat
establishment meets the requirements of point (a), the system shall not be
implemented.

is  not  convinced 

that 

43

To assess whether a meat establishment meets the requirements of point
(a), the competent authority shall conduct an analysis of production and
inspection  records,  the  type  of  activities  undertaken  in  the  meat
establishment,  its  history  of  compliance  with  legislation,  expertise,
professional attitude and sense of responsibility as regards food safety of
the staff of the establishment and any other relevant information.

2. Member  States  with  at  least  five  years  of  experience  with  staff  of
establishments  carrying  out  inspections  in  the  poultry  sector,  may  extend  the
system  provided  for  in  point  1(a)  to  the  fattening  pig  and  the  fattening  veal
sectors under the following conditions:

(a)

(b)

(c)

the  Member  State  concerned  shall  submit  an  evaluation  report  to  the
Commission and the Member States proving that the system has, during
those five years, operated successfully in the poultry sector.

the Food and Veterinary Office of  the Commission shall, when  deemed
necessary  by  the  Commission,  carry  out  an  audit  of  the  system  in  the
Member State to confirm its successful operation;

the Commission may require that the Member State returns to inspection
of  fattening  pigs  or  fattening  veal  calves  by  official  auxiliaries  or  takes
any other appropriate measure, when a report of the Food and Veterinary
Office or other information indicates that the Member State may  not be
able to guarantee adequate hygiene or inspection in the pig or veal meat
establishments.

The  conditions  applying  to  the  implementation  of  the  system  in  the  poultry
sector, set out in points 1 (a) and 1 (b), shall also apply to the implementation
of the system in the fattening pig and fattening veal sectors.

3.

Staff  of  the  establishment  having  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.

IV.

PROFESSIONAL QUALIFICATIONS

A.

Professional qualifications of the official veterinarian

1.

Only  veterinarians  who  have  passed  a  test  organised  by  the  competent
authority, as defined by Regulation (EC) No …/… [on official feed and
food controls], or by the organisation designated for that purpose by the
competent authority, may be appointed as official veterinarians.

44

2.

The test referred to in point 1 shall confirm knowledge of the following
subjects  to  the  extent  necessary  depending  on  the  veterinarian’s
background  and  qualifications  should  cover  at  least  the  following
subjects:

(a) Community  and  national  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  frauds,  including  in  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
hygienic practices’);

(g)

principles, concepts and methods of risk-analysis;

(h)

(i)

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

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

(j)

population dynamics of infections and intoxications;

(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 foodborne diseases in humans;

45

(r)

relevant 
encephalopathies;

aspects 

concerning 

transmissible 

spongiform

(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;

(v)

principles of training of personnel working in the production chain.

3.       Candidates for the test referred to in point 1 may have acquired 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 
take  account  of  candidates’
to 
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.

for  different 

tests 

4.       Veterinarians  already  appointed  as  official  veterinarians  must  have
adequate  knowledge  of  the  subjects  referred  to  in  point  2.  Where
necessary, they shall be required to acquire such knowledge through
continuing education activities. The competent authority shall make
make adequate provision for such continuing education activities.

5.

6.

7.

Official veterinarians shall be capable of prepared  for multidisciplinary
co-operation.

Detailed  rules  concerning  the  content  of  the  test  referred  to  in  point  1
shall  be  adopted,  where  appropriate,  in  accordance  with  the  procedure
referred to in Article 19(2).

In  addition,  a  veterinarian  shall  receive  at  least  200 hours  of  practical
training before being appointed as an official veterinarian. The practical
training shall:

(a)

be provided by official veterinarians;

(b)

(c)

take  place  in  slaughterhouses,  cutting  plants,  inspection  posts  for
fresh meat and holdings; and

concern,  among  other  things, auditing  of  food  safety  management
systems.

46

8.

9.

The  official  veterinarian  shall  maintain  up-to-date  knowledge  and  keep
abreast  of  new  developments  through  annual  continuing  education
activities and professional literature.

Veterinarians  already  appointed  as  official  veterinarians  and  part-time
official  veterinarians  shall,  where  necessary,  acquire  the  required
knowledge  on  the  subjects  referred  to  in  point  2  through  continuing
education activities. Adequate provisions shall be made by the competent
authority for such continuing educational activities.

B.

Professional qualifications of the official auxiliaries

1.

2.

3.

4.

Only  persons  who  have  passed  a  test  organised  by  the  competent
authority of the Member States, or by the organisation designated for that
purpose by the central competent authority, may be appointed as official
auxiliaries.

In order  to be  eligible  for the test  referred to  in  point  1,  candidates  must
prove that they have:

(a)

(b)

followed  at  least  600 hours  of  theoretical  training,  including
laboratory demonstrations; and

received at least 300 hours of practical training under the supervision
of an official veterinarian.

The  practical  training  referred  to  in  (b)  shall  take  place  under  the
supervision of an official veterinarian, in slaughterhouses, cutting plants,
inspection posts for fresh meat and holdings.

The practical training and tests referred to in point 1 shall focus either on
red meat or poultry meat. However, persons who were trained for one of
those  two  categories  and  passed  the  test,  may  undergo  a  shortened
practical training course in order to pass the test for the other category.

The  tests  for  official  auxiliaries  referred  to  in  point  1  shall  consist  of  a
theoretical part and a practical part and shall cover the following subjects:

(a)

for the inspection of holdings:

(i)

theoretical part:

(cid:1)

(cid:1)

familiarity  with  the  farming  industry  including  the
organisation,  production  methods,  and  international
trade;

pre-harvest quality management

47

(cid:1)

(cid:1)

(cid:1)

(cid:1)

(cid:1)

(cid:1)

(cid:1)

basic  knowledge  of  diseases,  in  particular  zoonotic
diseases - viruses, bacteria, and parasites.;

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

hygiene and health inspection;

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

environmental requirements - in buildings, on farms and
in general;

relevant  laws, regulations  and  administrative  provisions
applicable;

consumer concerns and quality control.

(ii)

practical part:

(cid:1)

(cid:1)

(cid:1)

(cid:1)

(cid:1)

(cid:1)

visits  to  farms  of  different  types  and  using  different
rearing methods;

visits to production establishments;

loading and unloading of means of transport;

visits to laboratories;

veterinary checks;

documentation.

(b)

for inspections at slaughterhouses:

(i)

theoretical part:

(cid:1)

(cid:1)

(cid:1)

the
familiarity  with 
organisation,  production  methods,  international  trade,
slaughter and cutting technology;

the  meat 

including 

industry 

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;

48

(cid:1)

(cid:1)

(cid:1)

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;

(cid:1)        knowledge of microbiology;

(cid:1)        examination for trichinosis;

(cid:1)

(cid:1)

(cid:1)

relevant 
spongiform encephalopathies;

knowledge 

concerning 

transmissible

knowledge of methods and procedures for the slaughter,
inspection,  preparation,  wrapping,  packaging  and
transport of fresh meat;

knowledge  of 
administrative provisions applicable;

the  relevant 

laws,  regulations  and

(cid:1)        ante-mortem inspections;

(cid:1)        post-mortem inspections;

(cid:1)

(cid:1)

sampling procedures;

fraud aspects;

(cid:1)        administrative tasks.

(ii)

practical part:

(cid:1)

(cid:1)

animal identification;

age checks;

(cid:1)        recording the results of ante-mortem inspections;

(cid:1)

(cid:1)

inspections and assessments of slaughtered animals;

post-mortem inspections in a slaughterhouse;

(cid:1)        examination for trichinosis;

49

(cid:1)

(cid:1)

(cid:1)

(cid:1)

(cid:1)

identification  of  animal  species  by  examination  of
typical parts of the animal;

identification  of  a  number  of  parts  of  slaughtered
animals in which changes have occurred, and comments
thereon;

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

sampling;

traceability of meat.

Detailed rules concerning the content of the test referred to point 1 shall
be adopted, where appropriate, in accordance with the procedure referred
to in Article 19(2).

The  total  duration  of  the  training  of  official  auxiliaries  shall  gradually
increase towards 1400 hours in by  2010, which shall  include practical
and  theoretical  training  in  ante-mortem  inspections,  HACCP  and
plant management including theoretical and practical training.

Official auxiliaries shall maintain up-to-date knowledge and keep abreast
of new developments through annual continuing education activities and
professional literature.

Chapter 3
Specific requirements

The  specific  requirements  laid  down  in  this  Chapter  shall  apply  in  addition  to  the
requirements of the Chapters 1 and 2.

I.

DOMESTIC BOVINE ANIMALS

I.1 Bovine animals over six weeks old

A.

Food chain information

For  the  slaughter  of  a  lot  of  bovine  animals  from  the  same  holding  of
the  food  chain
provenance  that  are  sent  directly  for  slaughter, 
information,  covering  the  matters  referred  to  under  Section  I.2.A  of
Chapter 1,  shall  be  sent 
the
slaughterhouse  24  to  72 hours  before  the  arrival  of  the  lot  at  the
slaughterhouse.

the  food  business  operator  of 

to 

50

When the food business operator decides to accept the lot for slaughter,
he  shall without delay  give a copy  of the  food  chain  information  to  the
official veterinarian, but in any case at least 24 hours before the arrival of
the lot.

B.

Post-mortem inspections

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

(a)

(b)

visual inspection of the head  and  throat;  incision  and examination
of  the  sub-maxillary,  retropharyngeal  and  parotid  lymph  nodes
(Lnn retropharyngiales, mandibulares and parotidei); examination
of  the  external  masseters,  in  which  two  incisions  must  be  made
parallel  to  the  mandible,  and  the  internal  masseters  (internal
pterygoid  muscles),  which  must  be  incised  along  one  plane;  the
tongue must  be  freed  to  permit  a  detailed  visual  inspection  of  the
mouth  and  the  fauces  and  must  itself  be  visually  inspected  and
palpated; the tonsils must be removed;

inspection  of  the  trachea  and  oesophagus;  visual  examination  and
palpation of the lungs; incision and 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
lungs  are  excluded  from  human
not  necessary  where 
consumption;

the 

(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)

(f)

visual  inspection  and  palpation  of  the  liver  and  the  hepatic  and
pancreatic  lymph  nodes,  (Lnn  portales);  incision  of  the  gastric
surface of the liver and at the base of the caudate lobe to examine the
bile ducts;

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

(g)

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

51

(h)

(i)

(j)

(k)

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

visual inspection of the pleura and the peritoneum;

visual inspection of the genital organs;

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.

I.2 Bovine animals under six weeks old

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

(a)

(b)

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;

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;
those incisions shall not be 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)

(f)

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

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

(g)

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

52

(h)

(i)

(j)

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

visual inspection of the pleura and peritoneum;

visual inspection and palpation of the umbilical region and the joints; in
the  event  of  doubt,  the  umbilical  region  must  be  incised  and  the  joints
opened; the synovial fluid must be examined.

II.

DOMESTIC SHEEP AND GOATS

A.

Food chain information

For  the  slaughter  of  a  lot  of  sheep  or  goats  from  the  same  holding  of
provenance  that  are  sent  directly  for  slaughter,  the  food  chain  information,
covering the matters referred to under Section 1.2.A of Chapter 1, shall be sent
to  the food business operator of the  slaughterhouse  24  to  72 hours  before  the
arrival of the lot at the slaughterhouse.

When  the  food  business  operator  decides  to  accept  the  lot  for  slaughter,  he
shall without delay give a copy of the information to the official veterinarian,
but in any case at least 24 hours before the arrival of the lot.

B.

Post-mortem inspections

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

(a)

(b)

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;  however,  without  prejudice  to  animal-health  rules,  such
examinations shall not be necessary if the competent authority is able to
guarantee  that  the  head,  including  the  tongue  and  the  brains,  is  to  be
excluded from human consumption;

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

(c)

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

(d)

visual inspection of the diaphragm;

(e)

visual inspection of the liver and the hepatic and pancreatic lymph nodes,
(Lnn portales); palpation of the liver and its lymph nodes; incision of the
gastric surface of the liver to examine the bile ducts;

53

(f)

visual  inspection  of  the  gastro-intestinal  tract,  the  mesentery  and  the
gastric and mesenteric lymph nodes (Lnn. gastrici, mesenterici, craniales
and caudales);

(g)

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

(h)

(i)

(j)

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

visual inspection of the pleura and peritoneum;

visual inspection of the genital organs;

(k)

visual inspection of the udder and its lymph nodes;

(l)

visual  inspection  and  palpation  of  the  umbilical  region  and  joints  of
young  animals;  in  the  event  of  doubt,  the  umbilical  region  must  be
incised and the joints opened; the synovial fluid must be examined.

III.

DOMESTIC SOLIPEDS

A.

Food chain information

The original  passport  accompanying the  animal  to  slaughter  shall  be  checked
by  the  official  veterinarian  to  ascertain  whether  the  animal  is  intended  to  be
slaughtered for human consumption.

B.

Post-mortem inspections

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

(a)

(b)

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;

lymph  nodes 

visual inspection  of the lungs,  trachea  and oesophagus; palpation of  the
lungs;  palpation  and,  if  necessary,  incision  of  the  bronchial  and
mediastinal 
(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;  however,  those  incisions  shall  not  be
necessary where the lungs are excluded from human consumption;

54

(c)

visual inspection of the pericardium and the heart, the latter being incised
lengthways  so  as 
the
interventricular septum;

the  ventricles  and  cut 

to  open 

through 

(d)

visual inspection of the diaphragm;

(e)

(f)

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

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

(g)

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

(h)

(i)

(j)

(k)

(l)

(m)

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

visual inspection of the pleura and peritoneum;

visual inspection of the genital organs of stallions and mares;

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

visual  inspection  and  palpation  of  the  umbilical  region  and  joints  of
young  animals;  in  the  event  of  doubt,  the  umbilical  region  must  be
incised and the joints opened; the synovial fluid must be examined;

all grey or white horses must be inspected for melanosis and melanomata
by examination of the muscles and lymph nodes (Lnn. subrhomboidei) of
the  shoulders  beneath  the  scapular  cartilage  after 
the
attachment of one shoulder; the kidneys must be exposed and examined
by incision through the entire kidney.

loosening 

IV.

DOMESTIC PIGS

A. Ante-mortem inspections

1.

Slaughter of a lot of pigs from a holding may be authorised only when:

(a)

either  the  pigs  intended  for  slaughter  have  been  submitted  to  an
ante-mortem  inspection  at  the  holding  of  provenance  and  are
accompanied by the health certificate provided for under Section X
of Chapter 3;or

55

(b)

the food chain information, covering the matters  referred to under
Section  1.2.  A  of  Chapter 1,  has  been  sent  to  the  food  business
operator of the slaughterhouse 24 to 72 hours before the arrival of
the pigs at the slaughterhouse.

When  the  food  business  operator  decides  to  accept  the  lot  for
slaughter, he shall without delay give a copy of the information to
the  official  veterinarian,  but  in  any  case  at  least  24 hours  before
arrival of the lot.

2.

The ante-mortem inspection at the holding of provenance shall comprise:

(a)

checking  the  records  or  documentation  of  the  holding,  including
the  food  chain  information  as  referred  to  in  Section  1.2.A  of
Chapter 1;

(b)

examination to determine whether the pigs:

(i)

(ii)

(iii)

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;

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

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

In addition, the following shall be carried out:

(a)

regular  sampling  of  water  and  feed  to  check  compliance  with
withdrawal periods; and where appropriate, sampling of the animals;

(b) where appropriate, tests for zoonotic agents.

3.

Ante-mortem  inspections  at  the  holding  shall  be  carried  out  by  the
official  veterinarian,  or  by  an  approved  veterinarian  taking  part  in  a
surveillance  network  system,  as  provided  for  by  Article 14  of  Directive
64/432/EEC; the pigs shall be sent directly to slaughter and not be mixed
with other pigs.

56

4. Where an ante-mortem inspection has been carried out at the holding, the
ante-mortem inspection at the slaughterhouse may be limited to a control
on the identification and a screening to ascertain whether animal welfare
rules  have  been  complied  with  and  signs  of  any  condition  which  might
adversely affect human or animal health are present.

5. Where an ante-mortem inspection has not been carried out at the holding,
the  official  veterinarian  shall  carry  out  ante-mortem  inspection  as
provided for under Section 1.2.B of Chapter 1.

6. Where the pigs are not slaughtered within three days of the issue of the
health  certificate  provided  for  in  point 1(a),  the  following  rules  shall
apply:

(a) where  the  pigs  have  not  left  the  holding  of  provenance,  the
procedure set out in point 1 (a) shall be repeated the pigs shall
be re-examined and a new health certificate shall be issued;

(b) where the pigs are already at the slaughterhouse, slaughter may be
authorised  once  the  reason  for  the  delay  has  been  assessed,
provided the pigs are subjected to a further veterinary ante-mortem
inspection.

B.

Post-mortem inspection

1.

Carcases and offal of pigs, other than fattening pigs raised:

(a)

under  controlled  housing  conditions,  in  integrated  production
systems;

(b) with  a  flow  of  information  between  holding  of  provenance  and
slaughterhouse considered satisfactory by the competent authority;

shall undergo the post-mortem inspection procedures set out in point 2.

(a)

(b)

visual inspection of the head  and  throat;  incision  and examination
of  the  submaxillary  lymph  nodes  (Lnn  mandibulares);  visual
inspection of the mouth, fauces and tongue;

visual inspection of the lungs, trachea and oesophagus; palpation of
the  lungs  and  the  bronchial  and  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;  those  incisions  are  not  necessary  where  the  lungs  are
excluded from human consumption;

57

(c)

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

(d)

visual inspection of the diaphragm;

(e)

(f)

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

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

(g)

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

(h)

(i)

(j)

(k)

(l)

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

visual inspection of the pleura and peritoneum;

visual inspection of the genital organs;

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

visual inspection and palpation of the umbilical region and joints of
young animals; in the event of doubt, the umbilical region must be
incised and the joints opened.

3.

Fattening  pigs  raised  under  controlled  housing  conditions,  in  integrated
production  systems,  with  a  flow  of  information  between  holding  and
slaughterhouses considered satisfactory by the competent authority, shall
undergo  visual  inspection  only.  The  competent  authority  may  however,
on the basis of epidemiological or other data, decide that some or all of
the procedures referred to in point 2 shall be applied to the fattening pigs.

V.

POULTRY

A. Ante-mortem inspections

1.

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

(a)

either  the  birds  intended  for  slaughter  have  been  submitted  to  an
ante-mortem  inspection  at  the  holding  of  provenance  and  are
accompanied by the health certificate as provided for under Section
X of this Chapter;or

58

(b)

the food chain information, covering the matters provided for under
Section  1.2.A  of  Chapter 1,  ,  has  been  sent  to  the  food  business
operator of the slaughterhouse 24 to 72 hours before the arrival of
the birds at the slaughterhouse.

Where  the  operator  decides  to  accept  the  birds  for  slaughter,  he
shall  without  delay  give  a  copy  of  the  information  to  the  official
veterinarian, but in any case at least 24 hours before the arrival of
the birds.

2.

The  ante-mortem  inspection  on  the  holding  of  provenance  shall
comprise:

(a)

checking  the  records  or  documentation  of  the  holding,  including
the food chain information as provided for under Section 1.2.A of
Chapter 1;

(b)

examination to determine whether the birds:

(i)

(ii)

(iii)

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;

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

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

3.

The following shall be carried out at the holding of provenance:

(a)

regular  sampling  of  water  and  feed  to  check  compliance  with
withdrawal periods; where appropriate, sampling of the animals;

(b) where appropriate, tests for zoonotic agents.

4.

Ante-mortem inspection at the holding shall be carried out by the official
veterinarian.

5. Where ante-mortem inspection has been carried out at the holding, ante-
mortem inspection at the slaughterhouse  may be  limited to a control  on
the  identification  and  a  screening  to  ascertain  whether  animal  welfare
rules  have  been  complied  with  and  signs  of  any  condition  which  might
adversely  affect human  or  animal health are  present;  the  screening  may
be carried out by an official auxiliary.

59

6. Where  ante-mortem  inspection  has  not  been  carried  out  at  the  holding,
the  official  veterinarian  shall  carry  out  an  examination  to  determine
whether the birds:

(a)

(b)

(c)

have a disease or condition transmissible to humans or animals or
are  behaving,  individually  or  collectively,  in  a  manner  indicating
that such a disease may occur;

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

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

Where  appropriate,  the  official  veterinarian  shall  carry  out  tests  for
zoonotic agents.

7. Where the birds are not slaughtered within three days of the issue of the
health  certificate,  as  set  out  in  Section  X  of  this  Chapter,  the  following
rules shall apply:

(a) where  the  birds  have  not  left  the  holding  of  provenance,  the
procedure set out in point 1 (a) shall be repeated the birds shall
be re-examined and a new health certificate shall be issued;

(b) where the birds are already at the slaughterhouse, slaughter may be
authorised  once  the  reason  for  the  delay  has  been  assessed,
provided the birds are re-examined.

8.

9.

If  the  birds  show  clinical  symptoms  of  a  disease,  their  slaughter  for
human  consumption  shall  be  prohibited.  However,  the  killing  of  those
birds  on  the  slaughterline  shall  be  authorised  at  the  end  of  the  normal
slaughter  process  provided  precautions  are  taken  to  avoid  the  risk  of
spreading  pathogenic  organisms  and  to  clean  and  disinfect  the  facilities
immediately after slaughter.

In  the  case  of  poultry  reared  for  the  production  of  foie  gras  and  in  the
case of delayed eviscerated poultry obtained at the holding of production,
ante-mortem inspection shall be carried out in accordance with points 2
and 3.

60

B.

Post-mortem inspection

All  birds  shall  undergo  post-mortem  inspection.  As  part  of  the  post-mortem
inspection, the official veterinarian shall:

(a)

(b)

(c)

(d)

inspect the viscera and body cavities of a representative number of birds
from each batch of birds from the same origin;

subject  to  a  detailed  inspection  a  random  sample  of  parts  of  birds  or
entire birds which were declared unfit for human consumption following
a post-mortem inspection;

carry  out  any  further  investigations  deemed  necessary  where  there  is
reason to  suspect  that the meat from the birds  concerned  could be  unfit
for human consumption;

in the case of poultry reared for the production of foie gras and delayed
eviscerated  poultry  obtained  at  the  holding  of  production,  control  the
health certificate as set out in point C that shall accompany the carcases.

C.

Specimen health certificate

HEALTH CERTIFICATE

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

Competent service:………………………………………..

No: ..........................................

1.

Identification of uneviscerated carcases

2.

3.

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

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

Provenance of uneviscerated carcases

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

Destination of uneviscerated carcases

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

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

61

4.

Declaration

I, the undersigned official veterinarian, 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  were  in  accordance
with the legal requirements and do not prohibit slaughter of the birds.

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

(Place)

(Date)

Stamp

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

VI.

FARMED LAGOMORPHS

The requirements applicable to poultry shall apply.

VII.

FARMED GAME

A. Ante-mortem inspection

1.

2.

Ante-mortem inspection may be carried out at the holding of provenance;
it  shall  be  carried  out  by  the  official  veterinarian  or  by  the  approved
veterinarian.  Ante-mortem  inspection  at  the  holding  shall  include
checking the records or documentation of the holding, including the food
chain information as provided for in Section 1.2.A of Chapter 1, regular
sampling  of  water  and  feed  and,  where  appropriate,  tests  for  zoonotic
agents. When an ante-mortem inspection has taken place at the holding,
the  ante-mortem  inspection  at  the  slaughterhouse  may  be  restricted  to
detecting  injuries  sustained  during  transport  and  a  check  of  the
identification of the animals.

Live animals inspected at the holding must be accompanied by  a health
certificate drawn up in accordance with the specimen set out in Section X
of  Chapter 3  stating  that  the  animals  were  inspected  at  the  holding  and
found to be healthy.

62

B.

Post-mortem inspection

1.

2.

The  post-mortem  inspection  shall  include  palpation  and,  where  judged
necessary, incision of those parts of the animal which have undergone any
change or are suspect for any other reason.

Post-mortem inspection procedures provided for in Section 1.B for bovine
and ovine animals, in Section  IV.B for domestic pigs and in Section V.B
for poultry shall be applied to the corresponding species of farmed game.

3. When  the  animals  have  been  slaughtered  at  the  holding,  the  official
veterinarian  shall  check  the  certificate  issued  and  signed  by  the  official
veterinarian  or  the  approved  veterinarian  attesting  to  a  favourable
result of ante-mortem inspection, correct slaughter and bleeding  and the
time of slaughter.

VIII. WILD GAME

A.

Post-mortem inspection

1. Wild game shall be inspected as soon as possible after admission to the

game handling establishment.

2.

is
The  official  veterinarian  shall  check  whether 
accompanied by a declaration of the trained person, as  defined in Annex
III,  Chapter  II,  point  4(a)  of  Regulation  (EC)  No  …/…  [laying  down
specific hygiene rules for food of animal origin]. Where the wild game is
accompanied by that declaration, he shall take this declaration into account
in carrying out the post-mortem inspection.

the  wild  game 

3.

During  the  post-mortem  inspection,  the  official  veterinarian  shall  carry
out:

(a)

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

(i)

detecting  any  abnormalities  not  caused  by  the  hunting
process; for this purpose, the diagnosis may be based on any
information provided by the hunter concerning the behaviour
of the animal before killing;

(ii)

checking  that  death  was  not  caused  by  reasons  other  than
hunting;

however, if an assessment cannot be made of the matters referred to
in  (i)  and  (ii)  on  the  basis  of  visual  examination  alone,  a  more
extensive inspection must be carried out in a laboratory;

63

(b)

an investigation of organoleptic abnormalities;

(c)

palpation of organs, where appropriate;

(d)

an  analysis  of  residues  including  environmental  contaminants  by
sampling,  where  there  are  serious  grounds  for  suspecting  the
presence  of  residues  or  contaminants;  where  a  more  extensive
inspection  is  made  on  the  basis  of  such  suspicions,  the  official
veterinarian  must  wait  until  that  inspection  has  been  concluded
before assessing all the game killed during a specific hunt, or those
parts which are suspected of showing the same abnormalities;

(e)

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

(i)

(ii)

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

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

(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;

(v)

the presence of parasites;

(vi)

formation  of  a  significant  amount  of  gas  in  the  gastro-
intestinal tract with discolouring of the internal organs;

(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;

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

4. Where the official veterinarian so requires, the vertebral column and the

head shall be split lengthways.

64

5.

6.

In the  case of small wild game not  eviscerated immediately  after  killing,
the  official  veterinarian  shall  carry  out  a  post-mortem  inspection  on  a
representative  sample  of  animals  from  the  same  source;  where  the  post-
mortem  inspection  reveals  a  disease  transmissible  to  man  or  defects  as
referred to in point 3, the veterinarian shall 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.

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  decisions  concerning  meat  provided  for  in  Section  II.E  of
Chapter 1,  meat  presenting  characteristics  during  post-mortem  inspection  as
listed  in  point A  of  that  Section,  shall  be  declared  unfit  for  human
consumption.

IX.

SPECIFIC HAZARDS

A.

Transmissible spongiform encephalopathies

1.

Inspection of bovine animals over six weeks old, sheep or goats shall be
carried  out  taking  into  account  Regulation  (EC)  No  999/2001,  and  all
other 
transmissible
spongiform  encephalopathies.  This  concerns  at  least  the  following
aspects:

legislation  concerning 

relevant  Community 

(a)      Where  appropriate,  the  status  of  the  dam  shall  be  checked  before

slaughter of the animal.

(b)     When  there  is  any  indication  that  the  age  as  mentioned  in  the
accompanying information is not correct, a dentition check shall be
carried out by the official veterinarian.

suffering 

(c)      Special care shall be taken that all bovine animals, sheep  or  goats
suspected  of 
spongiform
from  a 
encephalopathy,  as  defined  in  Regulation  (EC)  No  999/2001,  are
treated  in  accordance  with  the  specifications  of  that  Regulation.
These  suspect  animals  shall  be  slaughtered  separately  from  the
other  animals,  taking  all  necessary  precautions  to  limit  to  a
minimum the risk of contamination of other carcases, the slaughter
line and the staff present in the slaughterhouse.

transmissible 

65

2.       Specific 

tests 

for 

the  diagnosis  of 

encephalopathies  shall  be  carried  out  according 
Community legislation on this issue.

transmissible 
to 

spongiform
the  specific

Official  controls  carried  out  in  relation  to  TSEs  are  to  take  into
account the requirement of Regulation (EC) No 999/2001 and other
relevant Community legislation.

B.

Cysticercosis

1.

The post-mortem inspection  procedures set out under Sections  I  and  IV
of Chapter 3, shall be 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 shall not
be  compulsory  when  a  specific  serological  test  is  used  or  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  shall  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  shall  be  examined  for  trichinosis
unless the animals were raised on a holding officially certified to be free
of trichinosis, or a cold treatment has been applied.

2. Meat  from  animals  infected  with  trichinae  shall  be  declared  unfit  for

human consumption.

D. Glanders

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

2. Meat from horses in which glanders has been diagnosed shall be declared

unfit for human consumption.

66

E.

Tuberculosis

1.

Animals  which  have  reacted  positively  or  inconclusively  to  tuberculin
shall be slaughtered separately from the other animals, taking precautions
as to avoid the risk of contamination of other carcases, the slaughter line
and the staff present in the slaughterhouse.

2. Meat  from  animals  which  have  produced  a  positive  or  inconclusive
reaction  to  tuberculin  and  in  which  the  post-mortem  inspection  has
revealed  localised  tuberculous  lesions  located  in  a  number  of  organs  or
areas  of  the  carcase  shall  be  declared  unfit  for  human  consumption.
Pending  an  opinion  of  the  European  Food  Safety  Authority,  meat  from
animals  which  have  produced  a  positive  or  inconclusive  reaction  to
tuberculin  and  in  which  post-mortem  inspection  has  revealed  localised
tuberculous  lesions  in  the  lymph  node(s)  of  one  organ  or  part  of  the
carcase, shall be declared unfit for human consumption or undergo a heat
treatment.

F.

Brucellosis

1.

Animals which have reacted positively or inconclusively to a brucellosis
test  shall  be  slaughtered  separately  from  the  other  animals,  taking
precautions  as  to  avoid  the  risk  of  contamination  of  other  carcases,  the
slaughter line and the staff present in the slaughterhouse.

2. Meat from animals which have reacted positively or inconclusively to a
brucellosis  test,  confirmed  by  lesions  indicating  infection,  shall  be
declared  unfit  for  human  consumption.  Even  where  no  such  lesion  has
been  found,  the  udder,  genital  tract  and  blood  must  nevertheless  be
declared unfit for human consumption.

G. Detailed requirements

The following shall be established in accordance with the procedure referred to
in  Article  19(2),  and  after  the  European  Food  Safety  Authority  has  given  its
opinion:

(a)

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

(b)

the conditions under which holdings may be certified as officially free of
cysticercus or trichinae;

(c) where  appropriate,  methods  to  be  applied  when  examining  for  the
conditions referred to in this heading, including the serological tests to
examine for cysticercosis and possible procedures for examining for
trichinosis.

67

X.

SPECIMEN HEALTH CERTIFICATE

HEALTH CERTIFICATE

for animals transported from the holding to the slaughterhouse

Competent service:……………………………………….

No: ..........................................

1.

Identification of the animals

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

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

Identification marking: ........................................................................................................

2.

Provenance of the animals

Address of holding of provenance: .....................................................................................

Identification of house*:.......................................................................................................

3.

Destination of the animals

4.

5.

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

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

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

Other relevant information

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

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  were  in  accordance
with the legal requirements and do not prohibit slaughter of the animals.

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

(Place)

(Date)

Stamp

* optional

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

68

ANNEX II

LIVE BIVALVE MOLLUSCS

I.

OFFICIAL CONTROLS OF PRODUCTION AREAS

1.

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

(a) Class A areas: areas from which live bivalve molluscs may be collected
for  direct  human  consumption.  Live  bivalve  molluscs  taken  from  these
areas must meet the health standards for live bivalve molluscs referred to
in  Section VII  of  Chapter V  of  Annex  II  to  Regulation  (EC)  No  …/…
[laying down specific hygiene rules for food of animal origin].

(b) Class B areas: areas from which live bivalve molluscs may be collected,
but only placed on the market for human consumption after treatment in
a purification centre or after relaying so  as to  meet the health standards
referred  to  under  (a).  Live  bivalve  molluscs  from  these  areas  must  not
exceed  the  limits  of  a  five-tube,  three  dilution  Most  Probable  Number
(MPN)-test  of  6000  Faecal  coliforms  per  100 g  of  flesh  or  4600  E.coli
per 100 g of flesh in 90% of samples.

(c) Class C areas: areas from which live bivalve molluscs may be collected
but placed on the market only after relaying over a long period (at least
two months) whether or not combined with purification, or after intensive
purification  for  a  period  to  be  fixed  in  accordance  with  the  procedure
referred to in Article 19(2), so as to meet the health standards referred to
under  (a).  Live  bivalve  molluscs  from  these  areas  must  not  exceed  the
limits of a five-tube, three dilution MPN test of 60 000 faecal  coliforms
per 100 g flesh.

2.

In order to enable  the  classification of production zones and  to determine the
faecal contamination level of an area, the competent authority must:

(a) make  an  inventory  of  the  sources  of  pollution  from  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;

(c)

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

69

(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.

3.

Classified  relaying  and  production  areas  must  be  periodically  monitored  in
order to:

(a)

(b)

(c)

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

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

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

(d)

check for the presence of chemical contaminants in live bivalve molluscs.

4.

For  the  implementation  of  point 3(b),  (c)  and  (d),  sampling  plans  must  be
drawn up for carrying out such checks at regular intervals or on a case-by-case
basis  where  harvesting  periods  are  irregular.  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.

(a)

The  sampling  plan  for  checking  the  microbiological  quality  of  live
bivalve molluscs must take particular account of:

(i)

the likely variation in faecal contamination;

(ii)

the parameters referred to in point 2.

(b) The sampling plan for checking 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 be carried out as follows:

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

(ii)

periodic toxicity tests  using those molluscs  from  the  affected  area
most  susceptible  to  contamination;  harmonised  testing  methods
for marine biotoxins shall be laid down following the procedure
referred to in Article 19(2).

70

(c)

The sampling frequency for toxin analysis in the molluscs shall be as a
general  rule  at  least  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 suggest 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 shall be periodically reviewed in order to
assess the risk of toxins occurring in the live bivalve molluscs from these
areas.

(d) 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  in  order  to  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 shall only be allowed if
further analysis on the other species shows toxin levels below the limits.

(e) With  regard  to  the  monitoring  of  plankton,  the  samples  should  be
representative of the water column and shall 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  shall  be  increased  or  precautionary
closures of the areas shall be established until results of toxin analysis are
obtained.

(f)

The  sampling  plan  to  check  for  the  presence  of  chemical  contaminants
must  the  detection  of  any  overshooting  of  the  levels  laid  down  in
Regulation (EC) No 466/20011 are exceeded.

5. 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 production
area concerned must be closed for the harvesting of live bivalve molluscs.

Closed  areas  may  only  be  re-opened  when  the  health  standards  for  molluscs
comply again with Community legislation. When for reasons of the presence of
plankton or excessive levels of toxins in molluscs an area has been closed, at
least  two  consecutive  results  below  the  regulatory  limit  separated  at  least
48 hours are necessary to re-open it. Information on phytoplankton trends may
be included in this decision.  In those  cases 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.

6.

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

1

OJ L 77, 16.3.2001, p. 1.

71

                                                
7.

In  addition  to  the  monitoring  of  relaying  and  production  zones  referred  to  in
point 3, a control system must be set  up comprising laboratory  tests  to verify
compliance  with  the  requirements  for  the  end  product,  in  particular  to  verify
that the levels of marine biotoxins and contaminants do not exceed safety limits
and  that  the  microbiological  quality  of  the  molluscs  does  not  constitute  a
hazard to human health.

8.

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.

That  list  must  be  communicated  to  interested  parties  affected  by  this
Annex, including producers, gatherers and operators of purification centres
and dispatch centres.

(b)

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

(c)

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

9.

For deciding on the  classification, opening or  closure of  harvesting  areas, the
competent authority may take into account the results of controls carried out by
the  food  business  operators  or  by  the  organisation  representing  the  food
business  operators  concerned.  In  that  event,  the  analysis  must  have  been
carried out in a laboratory that has been approved by the competent authority
and in accordance with a protocol that has eventually been agreed between the
competent authority and the food businesses or organisation concerned.

II.

OFFICAL  CONTROLS  OF  PECTINIDAE  HARVESTED  OUTSIDE
CLASSIFIED PRODUCTION AREAS

Member States shall ensure that appropriate controls are organised on pectinidae that
have been harvested outside classified production areas in order to ensure that they
comply with the relevant health standards, including biotoxins.

72

ANNEX III

FISHERY PRODUCTS

1.

2.

Official  controls  on  fishery  products  shall  be  carried  out  at  the  time  of  landing  or
before first sale at an auction or wholesale market. Fish and other products derived
from aquaculture shall also be checked before they are placed on the market.

Official controls shall include:

(a) Organoleptic surveillance testing.

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

(b) Total Volatile Basic Nitrogen (TVB-N) tests.

Where the organoleptic examination reveals any doubt as to the freshness of the
fishery  products,  samples  may  be  taken  and  subjected  to  laboratory  tests  to
determine the levels of TVB-N (Total Volatile Basic Nitrogen).

The  TVB-N  levels  and  the  methods  of  analysis  to  be  used  shall  be  those
provided for in Articles 1 to 3 of Decision 95/149/EC.

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

(c) Histamine testing

Surveillance  testing  for  histamine  shall  be  carried  out  to  verify  compliance
with the permitted levels laid down in Community legislation.

The level of histamine in certain fishery products must be within the following
limits in nine samples taken from a batch:

(i)

the mean value must not exceed 100 ppm;

(ii)

two  samples  may  have  a  value  exceeding  100 ppm  but  not  more  than
200 ppm;

(iii) no sample may have a value exceeding 200 ppm.

Those  limits  shall  apply  only  to  fish  species  of  the  following  families:
Scombridae,  Clupeidae,  Engraulidae,  Coryfenidae,  Pomatomidae  and
Scombraesosidae. However, anchovy which has undergone enzyme maturation
treatment  in  brine  may  have  higher  histamine  levels  but  not  more  than  twice
the above values. Examinations must be carried out in accordance with reliable
methods which are recognised scientifically, including high performance liquid
chromatography (HPLC).

73

(d)

Surveillance testing for contaminants.

Monitoring arrangements shall be set up to control the levels in fishery products
of  contaminants  including  heavy  metals  and  organo-chlorinated  substances
present in the aquatic environment.

(e) Microbiological checks, where necessary.

(f)

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

(g) Official  Checks  on  the  possible  presence  on  the  market  of  poisonous  fish

species or fish containing biotoxins.

Where  necessary,  the  following  shall  be  established  in  accordance  with  the
procedure referred to in Article 19(2), after an opinion has been given by the
European Food Safety Authority:

(i)

freshness  criteria  for  the  organoleptic  evaluation  of  fishery  products,  in
particular  where  such  criteria  have  not  been  established  under  existing
Community legislation;

(ii)

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

3.

The following shall be declared unfit for human consumption:

(a)

(b)

(c)

fishery products when the organoleptic, chemical, physical or microbiological
checks have shown that such products are not fit for human consumption;

fish  or  parts  of  fish  which  have  not  been  properly  examined  to  detect  endo-
parasites in accordance with Community legislation;

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

(d)

poisonous fish and fishery products containing biotoxins;

(e)

fishery products or parts thereof considered dangerous to human health.

74

ANNEX IV

MILK AND MILK PRODUCTS

CHAPTER I: CONTROL OF HOLDINGS

1.

2.

3.

Animals  on  production  holdings  must  undergo  regular  veterinary  inspections  to
ensure  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. Those inspections may take place at the occasion of veterinary checks
carried out pursuant to other Community provisions.

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

The  production  holdings  shall  undergo  regular  checks  to  ensure  that  hygiene
requirements are being complied with. If it is shown that the hygiene is inadequate,
appropriate steps shall be taken to ensure that the operator corrects the situation.

CHAPTER II: CONTROL OF RAW MILK UPON COLLECTION

1.

2.

3.

The competent authority shall organise, where appropriate in co-operation with food
business operators producing or collecting milk or with the sector representing these
operators,  control  schemes  in  order  to  ensure  compliance  with  the  standards  that
apply to raw milk.

When the raw milk fails to meet such standards, the  competent  authority  shall  take
appropriate steps to ensure that the food business operator corrects the situation.

If  the  situation  is  not  corrected  within  three  months  after  notification  of  non-
compliance  with  those  standards,  the  milk  of  the  production  holding  shall  be
suspended  from  delivery  until  the  food  business  operator  has  proved  that  the  milk
complies again with the standards.

When the raw milk fails to meet mandatory public health criteria so that food safety
may  be  compromised,  the  competent  authority  shall  define  and  implement
procedures to suspend the delivering of the raw milk until conditions ensuring food
safety  are  restored.  At  the  same  time,  the  competent  authority  shall  instruct  the
farmer  as to whether the milk must be  destroyed, or whether  it  may  be  used  under
certain well defined conditions. As soon as those conditions are met, the competent
authority shall apply a procedure of re-authorisation of delivering milk.

CHAPTER III: CONTROL OF PROCESSED DAIRY PRODUCTS

Official controls shall include:

1.

A verification of the compliance of raw milk used for processing with the standards
that apply to it.

75

2.

3.

A  verification  that  food  safety  objectives  are  achieved,  by  appropriate  checks
performed on the means applied by the food business operators, including

(i)

heat treatment or other physical treatment parameters, or

(ii)

processing  conditions  in  general,  including  those  adapted  to  traditional
methods of production

A  verification  of  the  compliance  of  final  products  with  the  standards  that  apply  to
them, in particular as regards microbiological criteria and labelling.

76

ANNEX V

ESTABLISHMENTS NOT SUBJECT TO LISTING

The  following  third  country  establishments  need  not  appear  on  lists  drawn  up  and
updated in accordance with Article 9(4):

1.            establishments  handling  products  of  animal  origin  for  which  Annex III  to
Regulation (EC) …/… [laying down specific hygiene rules for products of animal
origin] does not lay down requirements;

2.            establishments carrying out only primary production;

3.            establishments carrying out only transport operations;

4.            establishments  carrying  out  only  the  storage  of  products  of  animal  origin  not

requiring temperature-controlled storage conditions.

77

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.  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.

78