Amended proposal for a Regulation of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin (presented by the Commission pursuant to article 250(2) of the EC Treaty)
Date: 2003-01-27
Institutions: European Commission
Subjects: agro-industry, animal product, consumer protection, food inspection, foodstuff, foodstuffs legislation

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 27.1.2003
COM(2003) 33 final

2000/0178 (COD)
2000/0179 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the hygiene of foodstuffs

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying down specific hygiene rules for food of animal origin

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

EXPLANATORY MEMORANDUM

I.

PROCEDURE

1.

2.

3.

On 14 July 2000, the Commission adopted a package of five proposals aiming
to  recast  Community  food  hygiene  legislation  [Document  COM  (2000)  438].
The  proposal  was  submitted  to  the  Council  and  the  European  Parliament  on
24 July 2000 for adoption by co-decision (except proposal 2000/0181, which is
based on Article 37 of the Treaty).

On  15  May  2002,  the  European  Parliament  has  in  first  reading  given  a
favourable opinion on three of the five proposals of the package.

The  present  proposal  amends  the  first  proposal  on  the  hygiene  of  foodstuffs
[document  2000/0178  (COD)]  of  the  package  so  as  to  take  into  account  the
the
amendments  of 
Commission.

the  European  Parliament 

that  were  accepted  by 

4. With  regard  to  proposal  2000/0178  (COD),  the  European  Parliament  adopted
102  amendments,  72 of which  were  accepted  by  the  Commission.  Mr.  Byrne
had indicated to the Plenary meeting on 14 May 2002 that he could accept most
of  the  amendments,  wholly  or  in  part,  and  subject  to  drafting  amendments,
except amendments 5, 8, 13, 14, 28-30, 35, 37-39, 47, 48, 53, 55, 58, 59, 67,
69, 71, 76, 77, 83, 89, 92, 93, 95, 105, 107 and 108.

The  amendments  are  in  bold  and  underlined.  A  number  of  amendments  have
been  reformulated  so  as  to  ensure  consistency  of  the  terminology  used
throughout the proposal. Extensive editorial changes are mentioned below.

Deletions  have  not  been  systematically  indicated.  Such  indications  would  in
certain  cases  have  lead  to  structural  complications  without  offering  more
transparency.  Deletions  concern  in  particular  the  definitions  in  Article 2
(certain definitions have been deleted in order to avoid overlap with Regulation
(EC) No 178/2002) and Article 10 (deleted for the same reason). Amendments
concerned: 18-24, 50, 54.

Annex I has been completely replaced by a newly structured text.

The  numbering  of  the  Articles  has  been  adapted  due  to  the  integration  of
Article 6 into Article 4, and the deletion of Article 10.

Within  certain Articles, the  numbering  of the paragraphs has been  adapted  in
order  to  take  into  account  the  addition  or  deletion  of  elements  in  the
Commission proposal.

2

5.

Certain technical changes have been made to the text to ensure its conformity
with  the  Inter-institutional  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 (d) thereof.

II.

OBJECTIVES OF THE PROPOSAL

6.

The  first  proposal  of  the  package  aims  to  establish  a  common  basis  for  the
hygiene  to  be  respected  by  all  food  business  operators.  It  contains  the
following key-issues:

– 

– 

– 

– 

– 

– 

– 

It applies from farm to table.

Food business operators have the prime responsibility over food safety.

The HACCP (Hazard Analysis Critical Control Point) system is proposed
as a tool to be implemented by food business operators in order to control
microbiological and chemical hazards in food and thus to promote  food
safety.

The establishment of guides to good practice by the food sectors in order
to  give  guidance  to  food  business  operators  on  food  safety  and  the
implementation of HACCP.

Flexibility  for  food  businesses  in  remote  areas,  for  traditional  food
production and for the implementation of HACCP in small businesses.

The registration of all food businesses with the competent authority.

Technical  issues  (premises,  equipment  etc.)  to  be  respected  by  food
businesses.

7.

The proposal corresponds to action 8 in the Annex to the White Paper on Food
Safety.

III.

OVERVIEW OF AMENDMENTS OF THE EUROPEAN PARLIAMENT

8.

Technical/editorial amendments

The majority of the proposed amendments aim to improve the proposal from a
technical  and  editorial  point  of  view.  These  amendments  have  largely  been
taken over by the Commission (Amendments concerned: 2, 4, 6, 9-partly, 10,
23, 25, 26, 39, 41, 51, 52, 65, 66, 68, 70, 72, 73, 74, 75, 78, 79, 80, 81, 82, 84,
85, 86, 87, 88, 90, 91, 94, 96, 97, 98, 99, 100, 101, 102, 106).

3

9.

Relation with Regulation 178/2002 (General Food Law)

A number  of  amendments  aim  to  bring  the  proposal  in  line  with  the  recently
adopted Regulation (EC) No 178/2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority and
laying  down  procedures  in  matters  of  food  safety.  These  amendments  have
largely been taken over by the Commission. (Amendments concerned: 1, 3, 11,
12, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 27, 50, 54, 56, 57, 61).

Amendment 107 overlaps with Regulation (EC) No 178/2002 and has therefore
not been taken into account.

10. Scope (Article 1)

Amendment 103 aims to clarify that the proposal does not apply to the direct
supply of small quantities of primary products to the final consumer and to the
local  retail  trade.  The  Commission  has  followed  this  amendment  since  it
considers that the operations covered by it are  a  matter  of subsidiarity.  In the
amended proposal, the Commission has clarified however that local retail trade
refers  to,  as  explained  in  the  justification  to  the  amendment,  local  shops  and
restaurants.

11. Comitology (Article 4§1, 2 and 3, Article 13)

The  Commission  proposed  a  regulatory  procedure  for  completing  and
amending  the  Annexes  to  the  Regulation,  as  well  as  for  granting  derogations
thereto  (the  latter  mandate  existing  already  in  Article  3  paragraph 3  of
Directive  93/43/EEC).  The  European  Parliament  did  not  follow 
the
Commission’s  proposal.  The  amendments  of  the  Parliament  on  this  subject
have not been taken over by the Commission. (Amendments concerned: 28, 29,
30, 58 and 59).

12. Microbiological and other criteria or standards

Amendment 106 provides for a redraft of the Commission proposal with regard
to  the  setting  of  microbiological  criteria,  temperature  criteria,  food  safety
targets and performance standards. This amendment sets a clear framework for
future decisions  on important  food  safety  factors,  and  is  therefore  a  welcome
precision  to  the  Commission’s  proposal.  It  must  be  ensured  however  that  the
same  terminology  is  used  consistently  throughout  the  amendment.  The
Commission  has 
this
amendment.

introduced  some  drafting  changes 

therefore 

to 

13. Flexibility (Article 4§4)

The proposal introduces flexibility for traditional food production, remote areas
and the implementation of HACCP. Furthermore, the text offers flexibility on
technical  matters  through  the  introduction  of  the  terms  "where  necessary",
"where  appropriate".  The  method  for  granting  flexibility  is  largely  based  on
subsidiarity. It will be mainly small businesses taking a profit of this flexibility.

4

The  need  for  flexibility  is  generally  endorsed.  Certain  amendments  aim  to
better describe where and how flexibility applies, and are therefore endorsed by
the  Commission,  subject 
(Amendments
concerned: 31, 32).

to  some  editorial  changes. 

14. Hazard Analysis Critical Control Point system (HACCP) (Article 5)

The proposal imposes the HACCP system to all food businesses except those
at the level of primary production (farmers) where hazards should be controlled
by  the use of  guides  to  good  farming  practice.  Several  amendments  aimed  to
introduce the HACCP system at the level of primary production. These are not
accepted  by  the  Commission,  since  the  general  application  of  the  HACCP
system  at  the  level  of  primary  production  is  considered  too  ambitious.
(Amendments concerned: 8, 9-first part, 35, 37, 38, 67).

One amendment  introduces  flexibility for  the application of  HACCP  (36-first
part).  This  is  favourably  accepted  by  the  Commission.  However,  the  second
part  of  amendment  36  imposes  documentation  on  HACCP  procedures  to  be
kept for an extensive period in time. It is considered that such a requirement, as
a general rule, is unrealistic in particular in the case of very small enterprises.

15. Guides to good practice (Articles 6 and 7)

The  proposal  introduces  the  possibility  to  establish  guides  to  good  practice
which are a voluntary instrument that can be used by food business as an assist
in ensuring a high level of food hygiene. Two amendments aim to clarify that
guides are  a  voluntary  instrument  (40,  45).  One  amendment  aims  to  preserve
status of guides developed under former rules (44). Three amendments aim to
clarify the procedure on how guides should be established (42, 43, 46). These
amendments  have  been  introduced  into  the  amended  proposal  with  some
drafting amendments.

Amendment  48  aims  to  ensure  that  Community  guides  prevail.  The
Commission  believes  that  since  both  national  and  Community  guides  are
voluntary  instruments,  food  business  operators  should  have  free  choice  to
implement either.

16. Registration of food businesses (Article 8)

The proposal provided for a systematic registration of all food businesses with
the competent authority, and to apply the registration number to the food that is
placed  on  the  market  (for  traceability  purposes).  Amendment 49  aims  to
introduce  flexibility  in  the  registration  procedure.  Amendment 50  aims  to
repeal  the  requirement  for  placing  the  registration  number  on  the  food,  since
traceability  is  adequately  covered  by  Regulation  (EC)  No  178/2002.  Both
amendments  are  in  line  with  the  Commission’s  policy  and  are  therefore
accepted.

However,  amendment  53  aims  to  introduce  a  new  requirement  for  the
traceability of food. Since this overlaps with Regulation (EC) No 178/2002, the
amendment is not followed.

5

17. Duties for competent authorities

The proposal defines the duties of food business operators and not the duties of
the  competent  authorities  (that  are  the  subject  of  separate  legislation).
However,  amendments  55  and  108  aim  to  introduce  duties  for  the  competent
authorities and fall therefore outside the scope of the proposal.

18. Support for developing countries

Amendment 13 aims to establish a support for developing countries. Although
such a support is an obligation under the WTO/SPS code, the proposal on food
hygiene  does  not  seem  to  be  the  right  place  to  introduce  such  a  requirement
into  Community  law.  The  Commission  will  reflect  on  this  question  in  the
context of possible future  proposals that  have  a more  generic  impact  on  food
law.

19. Report on implementation

The proposal contains a provision for the Commission to present a report to the
EP and Council within 7 years of the Regulation entering into force, reviewing
the experience gained from implementing the Regulation. Amendment 62 aims
to reduce the period of 7 years to 5  years. This seems a reasonable timeframe
for  the  Commission  to  get  the  necessary  experience  with  the  new  Regulation
and to present a report on its implementation.

20. Date of entry into force

The  proposal  foresees  that  the  Regulation  enters  into  force  on  the  date  of  its
publication  and  applies  on  the  date  of  1.1.2004.  Amendment 63  makes  the
Regulation  applicable  "one  year  after  its  entry  into  force".  This  seems  a
realistic approach.

21. Annex I on primary production

Amendments 64-74 aim to ensure a new presentation of the duties imposed on
the  primary  production  sector,  and  they  must  therefore  be  considered  as  an
editorial  issue.  The  Commission  has  taken  over  the  main  ideas  of  these
amendments but has taken the freedom to re-draft a number of the amendments
so  as  to  ensure  coherence  with  other  parts  of  the  proposal  and  to  ensure  a
consistent approach as regards terminology.

22. Technical requirements in Annex II

The  amendments  to  Annex  II  generally  aim  to  improve  the  proposal  from  a
technical  point  of  view.  Certain  of  these  amendments  risk  however  to  create
difficulties for very small enterprises. These amendments were not accepted by
the Commission. Amendments concerned: 76, 83, 101.

23. Pursuant  to  Article  250(2)  of  the  EC-Treaty,  the  Commission  amends  it

proposals in accordance with the lines set out above.

6

2000/0178 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the hygiene of foodstuffs

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular
Articles 95 and 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 Treaty,

Whereas:

(1) 

(2) 

(3) 

The  protection  of  human  health  is  of  paramount  importance.  The  fundamental
principles to  be  observed  with  a  view  to  attaining  a  high  level  of protection  are
laid down in Regulation (EC) No 178/2002 of the European Parliament and of the
Council  laying  down  the  general  principles  and  requirements  of  food  law,
establishing the European Food Safety Authority, and laying down procedures in
matters of food safety4.

In the context of the internal market, Council Directive 93/43/EEC of 14 June 1993 on
the hygiene of foodstuffs5 has been adopted in order to ensure the safety of foodstuffs
for human consumption in free circulation.

Directive 93/43/EEC fixes the principles with regard to the hygiene of foodstuffs and
in particular:

– 

the  standard  of  hygiene  throughout  all  stages  of  preparation,  processing,
manufacturing,  packaging,  storing,  transportation,  distribution,  handling  and
offering for sale or supply to the final consumer,

1

2

3

4

5

OJ C …
OJ C …
OJ C …
OJ L 31, 1.2.2002, p. 1.
OJ L 175, 19.7.1993, p. 1.

7

                                                
– 

– 

– 

– 

– 

the  need  to  base  the  standard  of  hygiene  on  the  use  of  hazard  analysis,  risk
assessment and other management techniques to identify, control and monitor
critical points,

the  possibility  of  adopting  microbiological  criteria  and  temperature  control
requirements for certain classes of foodstuffs in accordance with scientifically
accepted general principles,

the development of guides to good hygiene practice to which food businesses
may refer,

the  need  for  the  competent  authorities  of  the  Member States  to  ensure  the
observance of the hygiene rules with the aim of preventing the final consumer
from being harmed by foodstuffs unfit for human consumption,

the  obligation  on  food  business  operators  to  ensure  that  only  foodstuffs  not
harmful to human health are placed on the market.

(4) 

(5) 

(6) 

Experience  has  shown  that  these  principles  constitute  a  sound  basis  for  ensuring  the
safety of foodstuffs.

In  the  context  of  the  common  agricultural  policy,  specific  health  rules  affecting  the
production  and  placing  on  the  market  of  products  included  in  the  list  contained  in
Annex I to the Treaty have been established;

These health rules have not always sufficiently ensured that barriers to trade for the
products  concerned  were  removed,  and  thus  have  not  fully  contributed  to  the
creation of the internal market.

(7) 

These specific rules are contained in a large number of Directives.

(8)  With  regard  to  public  health,  these  Directives  contain  common  principles  such  as
those related to the responsibilities of manufacturers of products of animal origin, the
obligations  of  the  competent  authorities,  the  technical  requirements  for  the  structure
and  operation  of  establishments  handling  products  of  animal  origin,  the  hygiene
requirements which must be complied with in these establishments, the procedures for
the  approval  of  establishments,  the  conditions  for  storage  and  transport,  the  health
marking of the products.

(9)  Many  of  these  principles  are  the  same  as  the  principles  laid  down  in  Directive

93/43/EEC.

(10)  The principles laid down in Directive 93/43/EEC can therefore be considered to be a
common  basis  for  the  hygienic  production  of  all  foodstuffs,  including  products  of
animal origin included in Annex I to the Treaty.

8

(11) 

In addition to this common basis, specific hygiene rules are needed in order to take the
specificity of certain foodstuffs into account. For products of animal origin those rules
are  contained  in  Regulation  (EC)  No  …/…  of  the  European  Parliament  and  of  the
Council laying down specific hygiene rules for foodstuffs of animal origin6.

(12)  The  principle  objective  of  the  general  and  specific  hygiene  rules  is  to  ensure  a  high
level  of  consumer  protection  with  regard  to  the  safety  of  foodstuffs,  taking  into
account in particular:

– 

– 

– 

– 

– 

– 

– 

– 

the principle that primary responsibility for the safety of foodstuffs rests with
the food business operator within the scope of its own activities,

the need to ensure the safety of foodstuffs throughout the food chain, starting
with primary production;

the need to maintain the cold chain for foodstuffs that cannot safely be stored at
ambient temperatures, especially for frozen foodstuffs;

the  general  implementation  of  the  hazard  analysis  critical  control  points
(HACCP)  system  which,  together  with  the  application  of  good  hygiene
practice, should reinforce the responsibility of food business operators;

the value of guides to good practice which include guidance for food business
operators at all levels of the food  chain on the compliance  with  food  hygiene
rules;

the need to carry out official controls at all stages of production, manufacture
and placing on the market;

the  establishment  of  microbiological  criteria  and 
requirements based on a scientific assessment of risk;

temperature  control

the  need  to  ensure  that  imported  foodstuffs  are  of  at  least  the  same  or  an
equivalent health standard.

(13)  The safety of foodstuffs from the place of primary production up to the point of sale to
the consumer requires an integrated approach where all food business operators must
ensure that the safety of foodstuffs is not compromised.

(14)  Food hazards already present at the level of primary production must be identified and

adequately controlled.

(15)  HACCP is an instrument to help food business operators attain a higher standard
of food safety. HACCP should not be regarded as a method of self-regulation and
does not replace official controls.

6

OJ L …

9

                                                
(16)  Hygiene  at  farm  level  can  be  organised  through  the  use  of  codes  of  good  practice,
supplemented where necessary with specific hygiene rules  to be  observed during  the
production of primary products. Although application of the full HACCP system in
the  primary  sector  is  currently  not  generally  feasible  from  a  practical  point  of
view, the possible introduction of its principles should be examined.

(17)  Food  safety  is  a  result  of  several  factors  including  the  respect  of  mandatory
requirements, the implementation of food safety programmes established and operated
by food business operators and the implementation of the HACCP system.

(18)  The  HACCP  system  in  the  production  of  foodstuffs  should  take  account  of  the
principles already laid down by the Codex Alimentarius allowing at the same time the
flexibility  needed  for  its  application  in  all  situations,  and  in  particular  in  small
businesses.

(19)  Flexibility is also needed so as to take account of the specific character of traditional
ways of the production of foodstuffs and of the supply difficulties that may arise due
to  geographical  constraints;  such  flexibility  must  not  however  compromise  the
objectives of food safety.

(20)  For foodstuffs which cannot be safely stored at ambient temperatures, the maintenance
of the integrity of the cold chain is a basic principle of the hygiene of foodstuffs;

(21)  The implementation of the hygiene rules must be guided by the setting of objectives
such  as  pathogen  reduction  targets  or  performance  standards  and  it  is  necessary  to
provide for the procedures for that purpose.

(22)  The  traceability  of  foodstuffs  and  foodstuff  ingredients  along  the  food  chain  is  an
essential element  in ensuring food safety. Rules  to  ensure  traceability  of  food  and
food  ingredients  and  procedures  to  implement  these  provisions  in  the  specific
sectors, are already contained in Regulation (EC) No 178/2002.

(23)  Food  businesses  should  be  registered  with  the  competent  authority  in  order  to  allow

official controls to be performed efficiently.

(24)  Food  business  operators  must  give  all  assistance  required  in  order  to  ensure  that

official controls can be carried out efficiently by the competent authorities.

(25) 

In  accordance  with  Articles  11  and  12  of  Regulation  (EC)  No 178/2002,  food
imported  into,  or  exported  from  the  Community  should  follow  the  hygiene
principles laid down in this Regulation, unless specific circumstances are met.

10

(26)  Scientific advice must underpin Community legislation on the hygiene of  foodstuffs;
to  this  end,  the  European  Food  Safety  Authority  should  be  consulted  wherever
necessary.

(27) 

In  order  to  take  account  of  technical  and  scientific  progress,  a  procedure  should  be
available to adopt certain requirements called for in the present Regulation.

(28)  The present  Regulation takes into account  the  international obligations laid down  on

the WTO-Sanitary and Phytosanitary Agreement and in Codex Alimentarius.

(29)  The  present  recasting  of  existing  Community  food  hygiene  rules  means  that  the
existing  hygiene  rules  can  be  repealed,  including  those  laid  down  in  Directive
93/43/EEC,  which  will  be  further  harmonised  by  this  Regulation;  this  is  achieved
through  European  Parliament  and  Council  Directive  .../.../EC  repealing  certain
Directives on the hygiene of foodstuffs and on the health conditions for the production
and  placing  on  the  market  of  certain  products  of  animal  origin  intended  for  human
consumption, and amending Directives 89/662/EEC and 91/67/EEC7.

(30)  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/EEC
of 28 June 1999 laying down the procedures for the exercise of implementing powers
conferred  on  the  Commission8,  they  should  be  adopted  by  use  of  the  regulatory
procedure provided for in Article 5 of that Decision.

(31) 

It  is  necessary  and  appropriate  for  the  achievement  of  the  basic  objectives  of  this
Regulation  to  provide  for  the  further  approximation  of  concepts,  principles  and
procedures previously established under Directive 93/43/EEC. In accordance with the
principles of proportionality as set out in Article 5 of the Treaty, this Regulation does
not go beyond what is necessary in order to achieve the objectives pursued,

HAVE ADOPTED THIS REGULATION:

Article 1
Scope

1.

This Regulation lays down the rules to ensure the hygiene of foodstuffs at all stages
of  production,  processing  and  distribution.  This  Regulation  shall  apply  without
prejudice to more specific  food  safety  requirements  applicable to certain  categories
of  foodstuffs,  and  in  particular  to  food  of  animal  origin,  and  to  rules  relating  to
nutrition or compositional matters.

2.

This Regulation shall not apply to:

(a)

the primary production of foodstuffs for private domestic use;

(b)

the domestic preparation of foodstuffs for private consumption;

7

8

OJ L …
OJ L 184, 17.7.1999, p. 23.

11

                                                
(c)

the direct supply by the producer of small quantities of primary products
to  the  final  consumer  or  to  local  shops  and  restaurants;  such  operations
shall be subject to national rules.

Article 2
Definitions

For  the  purposes  of  this  Regulation,  the  definitions  laid  down  in  Regulation  (EC)
No 178/2002 shall apply. In addition, the following definitions shall apply:

(a)

(b)

(c)

(d)

(e)

(f)

(g)

(h)

(i)

(j)

(k)

"food  hygiene",  hereinafter  called  "hygiene"  means  the  measures  and  conditions
necessary to control hazards and ensure fitness for human consumption of a foodstuff
taking into account its intended use;

"competent  authority/ies"  means  the  central  authority/ies  of  a  Member  State
responsible  for  the  purposes  and  controls  set  out  in  this  Regulation  or  any  other
authority  or  body  to  which  competence  has  been  delegated  by  the  central
authority/ies;

"certification"  means  the  procedure  by  which  the  competent  authorities  provide
written or equivalent assurance of conformity to requirements;

"equivalence" means the capability of different systems to meet the same objectives;

"contamination"  means  the  presence  of  a  substance  not  intentionally  added  to
foodstuffs or present in the food environment, which may compromise the safety or
fitness for human consumption of the foodstuffs;

"wrapping"  means  the  protection  of  a  product  by  the  use  of  a  wrapping  or
container  in  direct  contact  with  the  product  concerned,  and  the  wrapper  or
container itself;

"packaging"  means  the  placing  of  one  or  more  wrapped  foodstuffs  in  a  second
container,  and  the  latter  container  itself;  if  wrapping  is  strong  enough  to  ensure
effective protection, it can be considered to be packaging;

"products  of  animal  origin"  means  foodstuffs  obtained  from  animals,  including
honey and blood;

"product of plant origin" means foodstuffs obtained from plants;

"unprocessed  product"  means  foodstuffs  which  have  not  undergone  a  treatment,
including  products  which  have  been,  for  example,  divided,  parted,  severed,  boned,
minced, skinned, ground, cut, cleaned, trimmed, husked or milled, chilled, frozen or
deep-frozen;

"processed product" means foodstuffs resulting from the application to unprocessed
products of a treatment such as heating, smoking, curing, maturing, pickling, drying,
marinating,  extraction,  extrusion  etc.  or  a  combination  of  these  processes  and/or
products;  substances  necessary  for  their  manufacture  or  for  giving  specific
characteristics to the products may be added;

12

(l)

(m)

"hermetically sealed container" means a container that is designed and intended to be
secure against the entry of micro-organisms;

"where necessary", "where appropriate", "sufficient" mean  where revealed necessary,
appropriate or sufficient after hazard analysis in the context of the HACCP system.

Article 3
General obligation

In  addition  to  the  general  principles  laid  down  in  Regulation  (EC)  No 178/2002,  food
business operators shall ensure that all stages of production, processing and distribution of
food under their control satisfy the hygiene  requirements laid down in  this  Regulation
that are relevant to their activities.

1.

2.

3.

4.

Article 4
General hygiene requirements and specific hygiene requirements

Food  business  operators  at  the  level  of  primary  production  shall  comply  with  the
general  hygiene  provisions  in  Annex  I  hereto,  any  other  specific  provisions  in
Regulation  (EC)  No  …/…  (laying  down  specific  hygiene  rules  for  food  of  animal
origin), and in any other Annexes relevant to their activities which may be added to
this Regulation in accordance with the procedure laid down in Article 13(2).

Food business operators, other than referred to in paragraph 1, shall comply with the
general  hygiene  provisions  in  Annex  II,  any  other  specific  provisions  laid  down  in
Regulation  (EC)  No  …/…  (laying  down  specific  hygiene  rules  for  food  of  animal
origin) and in any other annexes relevant to their activity which may be added to this
Regulation in accordance with the procedure laid down in Article 13(2).

Exemptions from provisions of the Annexes referred to in paragraphs 1 and 2 may be
granted  in  accordance  with  the  procedure  laid  down  in  Article 13(2),  provided  that
such exemptions do not affect the achievement of the objectives of this Regulation.

A  Member  State  may,  in  co-operation  with  the  Commission  and  in  accordance
with the procedure referred to in paragraph 5, adapt the requirements laid down
in  Annexes  I  and II,  provided  that  the  objectives  of  food  hygiene  are  not
compromised, with a view to:

(a)

(b)

accommodating the needs of food businesses situated in regions suffering from
special  geographical  constraints  or  affected  by  supply  difficulties  which  are
serving the local market, or

take account of traditional methods of production or the use of raw materials
which  are,  according  to  scientific  findings,  established  practice  or
tradition, characteristic of the production process.

13

5.

Member  States  having  recourse  to  the  possibility  referred  to  in  paragraph 4  shall
notify the Commission and the other Member States and supply them with a list of
products  and  the  regions  concerned  as  well  as  the  adjustments  made  to  adapt
hygiene  rules.  Member  States  may,  within  one  month  of  the  receipt  of  the
notification,  send  written  comments  to  the  Commission.  Where  appropriate,  a
decision shall be taken in accordance with the procedure referred to in Article 13(2).

6.

Food business operators shall:

7.

8.

1.

(a)

ensure that temperature criteria for foodstuffs are complied with and that
the cold chain is maintained,

(b)

ensure that microbiological criteria for foodstuffs are complied with,

(c)

take  measures  or  adopt  procedures  necessary  to  meet  targets  and
performance standards set to achieve the objectives of this Regulation,

(d)

use appropriate methods of sampling and analysis.

The  criteria,  targets,  performance  standards  and  methods  referred  to  in
paragraph  6 shall be adopted in accordance with  the  procedure  referred  to  in
Article 13(2).

Pending the setting of the criteria, targets, standards and methods referred to in
paragraph 6, the relevant criteria, targets, standards and methods laid down in
the  Directives  referred  to  in  Articles  1  and  2  of  Directive  …/…  (repealing
certain Directives on the hygiene of foodstuffs and on the health conditions for
the  production  and  the  placing  on  the  market  of  certain  products  of  animal
origin,  and  amending  Directives  89/662/EEC  and  91/67/EEC),  or  their
implementing  rules,  shall  continue  to  apply,  as  shall  national  rules  adopted  in
accordance with those Directives or their implementing rules.

Article 5
Hazard analysis and critical control points (HACCP) system

Food  business  operators  other  than  at  the  level  of  primary  production  shall  put  in
place,  implement  and  maintain  a  permanent  procedure  based  on  the  following
principles of the HACCP system:

(a)

(b)

(c)

identify  any  hazards  that  must  be  prevented,  eliminated  or  reduced  to
acceptable levels,

identify  the  critical  control  points  at  the  step  or  steps  at  which  control  is
essential to prevent or eliminate a hazard or reduce it acceptable levels,

establish  critical  limits  at  critical  control  points  which  separate  acceptability
from unacceptability for the prevention, elimination or reduction of identified
hazards,

(d)

establish  and  implement  effective  monitoring  procedures  at  critical  control
points,

14

2.

3.

4.

5.

1.

(e)

establish  corrective  actions  when  monitoring  indicates  that  a  critical  control
point is not under control.

Food business operators other than at the level of primary production shall establish
procedures  to  verify  whether  the  measures  referred  to  in  paragraph 1  are  working
effectively. Verification procedures shall  be carried  out  regularly and  whenever  the
food business operation changes in a manner that could adversely affect food safety.

In  order  to  facilitate  official  controls,  food  business  operators  other  than  at  the
level  of  primary  production  shall  provide  evidence  to  the  competent  authority
that they are complying with paragraphs 1 and 2. Where the nature and size of
a food business so necessitates, such evidence shall include documentation. Such
documentation shall be kept by the food business operator for at least the time of the
shelf life of the product.

As  part of  the system referred to in  paragraphs 1,  2  and  3, food  business  operators
may, on a voluntary basis, use guides to good practice in conjunction with guides
on  the  application  of  HACCP,  as  developed  in  accordance  with  Articles  6  and 7.
Such  guides  must  be  appropriate  for  the  operations  and  foods  to  which  they  are
applied by the food business operator.

In  accordance  with  the  procedure  referred  to  in  Article 13(2),  measures  may  be
adopted in order to facilitate the implementation of this Article, in particular in small
businesses.

Article 6
National guides to good practice and guides to the application of HACCP

Member  States  shall  encourage  the  development  of  guides  to  good  practice  which
shall  include  guidance  on  the  compliance  with  Article  3,  4  and  where  Article 5
applies,  the  application  of  the  principles  of  HACCP  (hereinafter  referred  to  as
national guides).

2.

Where national guides are developed, they shall be developed as follows:

– 

– 

– 

by food business sectors,

in  consultation  with  representatives  of  other  interested  parties,  such  as
competent  authorities  and  consumer  groups  whose 
interests  are
substantially affected,

where appropriate, having regard to the Recommended International Codes of
Practice of the Codex Alimentarius.

15

National  guides  may  be  developed  under  the  aegis  of  a  national  standards  institute
referred to in Annex I to Directive 98/34/EC9 of the European Parliament and of the
Council of 22 June 1998 laying down a procedure for the provision of information in
the field of technical standards and regulations as amended by Directive 98/48/EC10.

3.

Member States shall assess national guides to ensure:

(a)

(b)

(c)

(d)

(e)

that  the  contents  of  such  guides  are  practicable  for  the  sectors  to  which  they
refer,

have  been  developed  in  consultation  with  representatives  of  the  sector
concerned  and  other  interested  parties,  such  as  competent  authorities  and
consumer groups,

have been developed having regard to the Recommended International Code of
Practice, General Principles of Food Hygiene, of the Codex Alimentarius,

that  all  interested  parties  substantially  affected  have  been  consulted  and  the
relevant comments taken into account,

their  suitability  as  guides  to  compliance  with  the  provisions  of  Articles 3, 4,
and 5 in the sectors and/or for the foodstuffs covered.

Twelve  months  following  the  entry  into  force  of  this  Regulation,  and  thereafter
annually,  the  Member  States  shall  forward  to  the  Commission  a  report  concerning
the steps taken to develop national guides specified in paragraph 1.

Member  States  shall  forward  to  the  Commission  those  national  guides  which  they
have determined to comply with paragraph 3. The Commission shall keep a register
of such guides and make this available to the Member States.

The guides to good practice already developed and applied in accordance with
Directive  93/43/EEC may  continue to  be used after the  entry into  force  of  this
Regulation insofar as they are compatible with the objectives of this Regulation.

Article 7
Community guides

Where a Member State or the Commission considers that there is a need for uniform
Community guides to good practice, and/or Community guides on the application of
the  principles  of  HACCP  (hereinafter  referred  to  as  Community  guides),  the
Commission shall consult the Committee referred to in Article 13(1). The objective
of  this  consultation  shall  be  to  consider  the  case  for  such  guides,  their  scope  and
subject matter.

4.

5.

6.

1.

9

10

OJ L 204, 21.7.1998, p. 37.
OJ L 217, 5.8.1998, p. 18.

16

                                                
2.

Where,  pursuant  to  paragraph  1,  it  is  considered  that  there  is  a  need  for
Community guides, they shall be developed:

(a)

(b)

(c)

by representatives of the European sector concerned, including small and
medium sized enterprises (SMEs),

in consultation with other interested parties, such as competent authorities
and consumer groups,

taking into account the Recommended International Code of Practice, General
Principles of Food Hygiene, of the Codex Alimentarius and any national guides
developed in accordance with Article 6.

3.

The  Committee  referred  to  in  Article  13(1)  shall  be  responsible  for  assessing
Community guides with a view to ensuring:

4.

5.

1.

(a)

(b)

(c)

(d)

that  the  contents  of  such  guides  are  practicable  for  the  sectors  to  which  they
refer throughout the Community,

that  all  interested  parties  substantially  affected  by  such  guides  have  been
consulted, and the relevant comments taken into account,

that, where they exist, national guides are forwarded to the Commission under
Article 6(5) have been taken into account,

they  are  suitable  as  guides  to  compliance  with  the  provisions  of  Articles 3,
4, and 5 in the sectors and/or for the foodstuffs covered.

Where  national  guides  have  been  produced  in  accordance  with  Article 6  and
subsequently Community guides are produced in accordance with this Article, food
business operators may refer to either.

The titles and references of Community guides shall be published in the C series of
the Official Journal of the European Communities. Member States shall ensure that
such published guides are drawn to the attention of the relevant food business sectors
and the appropriate authorities in their territories.

Article 8
Registration or approval of Food Businesses

Food  business  operators  shall  notify  all  establishments  under  their  control  and
covered by this Regulation to the Competent Authority/ies outlining the nature of the
business, the name and address of all premises.

The  Competent  Authority/ies  shall  allocate  a  registration  number  to  each  food
establishment  and  keep  an  up  to  date  list  thereof.  They  may  use  registrations
already issued for other purposes.

Food  business  operators  shall  supply  the  competent  authority  with  the
information  required,  including  all  new  food  business  activities,  all  new
establishments and all closures of existing establishments, in order to keep the
list of premises up to date.

17

2.

Food business operators shall ensure that establishments under their control are
approved by the competent authority when required:

(a)

(b)

(c)

under the national law of the Member State in which the establishment is
located;

under  Regulation  (EC)  No  …/…  [laying  down  specific  hygiene  rules  for
food of animal origin]; or

by  a  measure  adopted  in  accordance  with  the  procedure  referred  to  in
Article 13(2).

3.

If  approval  is  required  for  an  establishment  pursuant  to  paragraph 2,  a  food
business operator may not operate an establishment without this approval after
an on-the-spot check of the establishment has shown that requirements relating
to  infrastructure  and  operations  are  complied  with  and  all  aspects  of  hygiene
have  been  examined  and  found  to  comply  with  the  relevant  provisions  of  this
Regulation.

Article 9
Official controls

Food business operators shall give all assistance needed to ensure that official controls carried
out by the competent authority can be performed efficiently. They shall in particular:

– 

– 

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

make available any documentation and record required under the present Regulation
or considered necessary by the competent authority for judging the situation.

Article 10
Imports / exports

For  the  purposes  of  Articles  11  and  12  of  Regulation  (EC)  No  178/2002,  the
implementation by food business operators importing or exporting food respectively, of
the hygiene requirements provided for in this Regulation shall be taken into account.

Article 11
Amending of annexes and implementing measures

1.

Provisions in the Annexes to this Regulation may be amended in accordance with the
procedure laid down in Article 13(2).

18

2.

Implementing  measures  in  relation  to  Articles  4,  5,  8  and  10  may  be  adopted  in
accordance with the procedure laid down in Article 13(2).

Article 12
References to international standards

Amendments  to  references  to  international  standards  contained  in  this  Regulation,  such  as
those of the Codex Alimentarius, may be adopted in accordance with the procedure referred to
in Article 13(2).

Article 13
Standing Committee procedure

1.

2.

3.

The Commission shall be assisted by the Standing Committee on the Food Chain
and Animal Health.

Where  reference  is  made  to  this  paragraph,  Articles  5  and 7  of  Decision
1999/468/EC shall apply, in compliance with Article 8 thereof.

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

Article 14
Report to Council and Parliament

The  Member  States  shall  submit  to  the  Commission,  within  four  years  after  the  entry  into
force of this Regulation, reports on its operation.

On the basis of these reports, the Commission shall, within five years after the entry into force
of  this  Regulation,  review  its  operation  and  submit  to  the  European  Parliament  and  the
Council a report, accompanied where necessary by legislative proposals.

19

Article 15
Entry into force

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

It shall apply as from ….

(cid:1)

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

(cid:1)

[one year after the entry into force of the Regulation]

20

                                                
ANNEX I

GENERAL HYGIENE RULES FOR PRIMARY PRODUCTION

CHAPTER I

Scope and requirements

I.

SCOPE

This Annex applies to the production of primary products and includes  associated
operations such as the transport, storage and handling of primary  products at
the place of production.

II.

GENERAL REQUIREMENTS

1.

2.

Food  business  operators  must  ensure,  as  far  as  possible,  that  primary
products  are  protected  against  contamination,  having  regard  to  any
processing that primary products will subsequently undergo.

Notwithstanding the general duty laid down in paragraph 1, food business
operators  must  comply  with  appropriate  Community  and  national
legislative  provisions  relating  to  the  control  of  hazards  in  primary
production, including:

(a) measures to  control  contamination  arising  from  the  air,  soil,  water,
feed,  fertilisers,  veterinary  medicinal  products,  plant  protection
agents and biocides, and the storage, handling and disposal of waste,
and

(b) measures relating to animal health and welfare and plant health that
have  implications  for  human  health,  including  programmes  for  the
monitoring and control of zoonoses and zoonotic agents. 

(c)

the  obligation  to  inform  the  competent  authority  if  a  problem  that  may
affect human health is suspected.

III.

REQUIREMENTS FOR PRODUCTS OF ANIMAL ORIGIN

Food  business  operators  rearing,  harvesting  or  hunting  animals  or  producing
primary  products  of  animal  origin  must 
take  adequate  measures,
as appropriate:

(a)

(b)

(c)

to  keep  any  facilities  used  in  connection  with  primary  production,
including  facilities  used  to  store  and  handle  feed,  clean  and,  where
necessary after cleaning, to disinfect them in an appropriate manner;

to  keep  clean  and,  where  necessary  after  cleaning,  to  disinfect  in  an
appropriate manner equipment, containers, crates, vehicles and vessels;

to ensure, as far as possible, the cleanliness of animals going to slaughter
and, where necessary, production animals;

21

(d)

to prevent, as far as possible, pests from causing contamination;

(e)

(f)

(g)

to  store  and  handle  waste  and  hazardous  substances  so  as  to  prevent
contamination;

the 

to  prevent 
introduction  and  spread  of  contagious  diseases
transmissible to humans through food, including by taking precautionary
measures  when 
introducing  new  animals  and  reporting  suspected
outbreaks of such diseases to the competent authority;

to  take  account  of  the  results  of  any  relevant  analyses  carried  out  on
samples  taken  from  animals  or  other  samples  that  have  importance  to
human health; and

(h)

to  use  feed  additives  and  veterinary  medicinal  products  correctly,  as
required by the relevant legislation.

IV.

REQUIREMENTS FOR PRODUCTS OF PLANT ORIGIN

Food  business  operators  producing  or  harvesting  plant  products  must  take
adequate measures, as appropriate:

(a)

to  keep  clean  and,  where  necessary  after  cleaning,  to  disinfect  in  an
appropriate  manner  facilities,  equipment,  containers,  crates  and  vehicles
[used with plant products];

(b)

to ensure, where necessary, the cleanliness of plant products;

(c)

to prevent, as far as possible, pests from causing contamination;

(d)

(e)

(f)

to  avoid  biological,  chemical  and  physical  hazards  such  as  mycotoxins,
heavy metals etc.;

to  store  and  handle  wastes  and  hazardous  substances  so  as  to  prevent
contamination; and

to  take  account  of  the  results  of  any  relevant  analyses  carried  out  on
samples  taken  from  plants  or  other  samples  that  have  importance  to
human health.

CHAPTER II

Record keeping

1.

2.

Food  business  operators  must  keep  records  relating  to  measures  taken  to
control food hazards.

Food  business  operators  rearing  animals  or  producing  primary  products  of  animal
origin must, in particular, keep records on:

(a)

the nature and origin of feed;

22

(b)

(c)

(d)

veterinary products or other treatments administered to animals, dates of
administration and withdrawal periods;

the occurrence of diseases that may affect the safety of products of animal
origin;

the results of any analyses carried out on samples taken from animals or
other  samples  taken  for  diagnostic  purposes,  that  have  importance  to
human health; and

(e)

any  relevant  reports  on  checks  carried  out  on  animals  or  products  of
animal origin.

When  animals  are  taken  to  a  slaughterhouse,  relevant  information  from  the
records  shall  be  communicated  to  the  competent  authorities  and  the  receiving
food business operator.

3.

Food  business  operators  producing  or  harvesting  plant  products  must,  in  particular
keep records on:

(a)

the use of plant protection agents and herbicides;

(b)

(c)

the occurrence of pests or diseases that may affect the safety of products of
plant origin; and

the  results  of  any  relevant  analyses  carried  out  on  samples  taken  from
plants or other samples that have importance to human health.

Food  business  operators  must  make  relevant  information  from  such  records
available on request to the competent authority  and to  receiving food business
operators.

Other  persons,  such  as  veterinarians,  agronomists  and  farm  technicians,  shall
assist the food business operator with the keeping of records.

The  records  may  be  combined  with  or  replaced  by  other  records  that  may  be
required under Community or national law.

CHAPTER III

Guides to good practice

National  and  Community  guides  referred  to  in  Articles  6  and 7  of  this
Regulation should contain guidance on good hygiene practice for the control of
hazards in primary production.

4.

5.

6.

1.

23

2.

Guides  to  good  hygiene  practice  should  include  appropriate  information  on
hazards  that  may  arise  in  primary  production  and  actions  to  control  hazards,
including  relevant  measures  set  out  in  Community  and  national  legislation  or
national and Community programmes. Examples of such hazards and measures
may include:

(a)

the  control  of  contamination  such  as  mycotoxins,  heavy  metals  and
radioactive material;

(b)

the use of water, organic waste and fertilisers;

(c)

(d)

the  correct  and  appropriate  use  of  plant  protection  agents  and  their
traceability;

the correct and appropriate use of veterinary medicinal products and feed
additives and their traceability;

(e)

the preparation, storage, use and traceability of feed;

(f)

the proper disposal of dead animals, waste and litter;

(g)

(h)

protective  measures  to  prevent  the  introduction  of  contagious  diseases
transmissible  to  humans  through  food,  and  any  obligation  to  notify  the
competent authority;

procedures,  practices  and  methods  to  ensure  that  food  is  produced,
handled,  packed,  stored  and  transported  under  appropriate  hygienic
conditions, including effective cleaning and pest-control;

(i) measures relating to the cleanliness of slaughter and production animals;

and

(j) measures relating to record-keeping.

24

ANNEX II

GENERAL HYGIENE REQUIREMENTS APPLYING TO ALL FOOD BUSINESSES
(EXCEPT PRIMARY PRODUCTION)

Introductory remarks

Chapters V to XII of this Annex apply throughout all stages after primary production during
preparation,  processing,  manufacturing,  packaging,  storing,  transportation,  distribution,
handling and offering for sale or supply to the final consumer.

The remaining Chapters of the Annex apply as follows:

– 

– 

– 

– 

1.

2.

Chapter I to all food premises except those covered by Chapter III,

Chapter  II  to  all  rooms  where  food  is  prepared,  treated  or  processed  except  those
covered by Chapter III and excluding dining areas,

Chapter III to those premises listed in the heading to the Chapter,

Chapter IV to all transportation.

CHAPTER I

General requirements for food premises including outside areas and sites
(other than those specified in Chapter III)

Food premises must be kept clean and maintained in good repair and condition.

The layout, design, construction, siting and size of food premises shall:

(a)

(b)

(c)

permit adequate maintenance, cleaning and/or disinfection, avoid or minimise
air-borne  contamination,  and  have  adequate  working  space  to  allow  for  the
hygienic performance of all operations;

be  such  as  to  protect  against  the  accumulation  of  dirt,  contact  with  toxic
materials, the shedding of particles into food and the formation of condensation
or undesirable mould on surfaces;

food  hygiene  practices, 

permit  good 
including  protection  against
contamination  between  and  during  separate  operations  from  foodstuffs,
wrapping  and  packaging  materials,  equipment,  materials,  water,  air  supply  or
personnel and external sources of contamination such as pests;

(d) Where  it  is  necessary  for  the  purposes  of  achieving  the  objectives  of  this
Regulation,  provide  suitable  temperature-controlled  storage  conditions  of
sufficient  capacity  for  maintaining  foodstuffs  at  appropriate  temperatures  and
designed to allow those temperatures to be monitored and recorded.

25

3.

4

5.

6.

7.

8.

9.

10.

An  adequate  number  of  washbasins  must  be  available,  suitably  located  and
designated  for  cleaning  hands.  An  adequate  number  of  flush  lavatories  must  be
available  and  connected  to  an  effective  drainage  system.  Lavatories  must  not  open
directly into rooms in which food is handled.

Washbasins  for  cleaning  hands  must  be  provided  with  hot  and  cold  running  water,
materials for cleaning hands and for their hygienic drying. Where necessary to avoid
an unacceptable  risk of contamination  of  food, the facilities for washing  food  must
be separate from the hand-washing facility.

There  must  be  suitable  and  sufficient  means  of  natural  or  mechanical  ventilation.
Mechanical  airflow  from  a  contaminated  area  to  a  clean  area  must  be  avoided.
Ventilation  systems  must  be  so  constructed  as  to  enable  filters  and  other  parts
requiring cleaning or replacement to be readily accessible.

Sanitary  conveniences  shall  be  provided  with  adequate  natural  or  mechanical
ventilation.

Food premises must have adequate natural and/or artificial lighting.

Drainage facilities must be adequate for the purpose intended; they must be designed
and  constructed  to  avoid  the  risk  of  contamination  of  foodstuffs.  Where  drainage
channels  are  fully  or  partially  open,  they  must  be  so  designed  to  ensure  that  waste
does not flow from a contaminated area towards and into a clean area or area where
foods likely to present a high risk to the final consumer are handled.

Where  and  as  necessary,  adequate  changing  facilities  for  personnel  must  be
provided.

Cleaning  agents  and  disinfectants  must  not  be  stored  in  areas  where  food  is
handled.

CHAPTER II

Specific requirements in rooms where foodstuffs are prepared, treated or processed
(excluding dining areas and those premises specified in Chapter III)

1.

In  rooms where food is  prepared,  treated or  processed (excluding  dining  areas  and
those premises specified in Chapter III but including compartments in vehicles)
the design and layout shall permit good food hygiene practices, including protection
against cross-contamination between and during operations, and in particular:

(a)

floor  surfaces  must  be  maintained  in  a  sound  condition  and  be  easy  to  clean
and,  if  necessary,  disinfect.  This  will  require  the  use  of  impervious,  non-
absorbent, washable and non-toxic materials unless food business operators can
satisfy the competent authority that other materials used are appropriate. Where
appropriate, floors must allow adequate surface drainage;

26

(b) wall  surfaces  must  be  maintained  in  a  sound  condition  and  be  easy  to  clean
and,  if  necessary,  disinfect.  This  will  require  the  use  of  impervious,  non-
absorbent, washable and non-toxic materials and require a smooth surface up to
a  height  appropriate  for  the  operations  unless  food  business  operators  can
satisfy the competent authority that other materials used are appropriate;

(c)

ceilings,  overhead  structures  and  the  inner  surfaces  of  roofs  must  be
constructed  to  prevent  the  accumulation  of  dirt  and  reduce  condensation,  the
growth of undesirable moulds and the shedding of particles;

(d) windows and other openings must be constructed to prevent the accumulation
of  dirt.  Those  which  can  be  opened  to  the  outside  environment  must  where
necessary be fitted with insect-proof screens which can be easily removed for
cleaning.  Where  open  windows  would  result  in  contamination  of  foodstuffs,
windows must remain closed and fixed during production;

(e)

(f)

doors must be easy to clean and, where necessary, disinfect. This will require
the  use  of  smooth  and  non-absorbent  surfaces  unless  food  business  operators
can satisfy the competent authority that other materials used are appropriate;

surfaces  (including  surfaces  of  equipment)  in  areas  where  foods  are  handled
and  in  particular  those  in  contact  with  food  must  be  maintained  in  a  sound
condition and be easy to clean and, if necessary, disinfect. This will require the
use  of  corrosion  resistant,  smooth,  washable  and  non-toxic  materials  unless
food business operators can satisfy the competent authority that other materials
used are appropriate.

2.

3.

Adequate  facilities  must  be  provided  for  the  cleaning  and  disinfecting  of  working
utensils  and  equipment  where  this  is  required  for  the  purposes  of  achieving  the
objectives  of  this  Regulation.  These  facilities  must  be  constructed  of  materials
resistant to corrosion and must be easy to clean and have an adequate supply of hot
and cold water.

Adequate provision must be made  for any necessary  washing of  food where this is
required to achieve the objectives of this Regulation. Every sink or other such facility
provided for the  washing of  food must have an adequate supply  of  hot  and/or  cold
potable water as required and be kept clean and, where necessary, disinfected.

CHAPTER III

Requirements for movable and/or temporary premises (such as marquees, market stalls,
mobile sales vehicles), premises used primarily as a private dwelling house but where
foods are prepared for purposes other than private and domestic consumption, premises
used occasionally for catering purposes, and vending machines

1.

Premises  and  vending  machines  shall  be  so  sited,  designed,  constructed  and  kept
clean  and  maintained  in  good  repair  and  condition  as  to  avoid  the  risk  of
contamination  of  foodstuffs,  in  particular  by  animals  and  pests,  so  far  as  is
reasonably practicable.

27

2.

In particular and where necessary:

(a)

(b)

appropriate facilities must be available to maintain adequate personal hygiene
(including  facilities  for  the  hygienic  washing  and  drying  of  hands,  hygienic
sanitary arrangements and changing facilities);

surfaces in contact with food must be in a sound condition and be easy to clean
and,  if  necessary,  disinfect.  This  will  require  the  use  of  corrosion  resistant,
smooth,  washable,  non-toxic  materials  unless  food  business  operators  can
satisfy the competent authority that other materials used are appropriate;

(c)

adequate  provision  must  be  made  for  the  cleaning  and,  if  necessary,
disinfecting of working utensils and equipment;

(d) where foodstuffs are cleaned as part of the food business’s operations adequate

provision must be made for this to be undertaken hygienically;

(e)

an adequate supply of hot and/or cold potable water must be available;

(f)

(g)

(h)

adequate arrangements and/or facilities for the hygienic storage and disposal of
hazardous and/or inedible substances and waste (whether liquid or solid) must
be available;

adequate facilities and/or arrangements for maintaining and monitoring suitable
food temperature conditions must be available;

foodstuffs must be so placed as to avoid the risk of contamination so far as is
reasonably practicable.

CHAPTER IV

Transport

1.

2.

3.

4.

Conveyances  and/or  containers  used  for  transporting  foodstuffs  must  be  kept  clean
and  maintained  in  good  repair  and  condition  in  order  to  protect  foodstuffs  from
contamination  and  must,  where  necessary,  be  designed  and  constructed  to  permit
adequate cleaning and/or disinfection.

Receptacles in vehicles and/or containers must not be used for transporting anything
other than foodstuffs where this may result in contamination of foodstuffs.

Where conveyances and/or containers have been used for transporting anything
other than foodstuffs or for transporting different foodstuffs, there must be an
effective cleaning between loads to avoid the risk of contamination.

Where conveyances and/or containers are used for transporting anything in addition
to foodstuffs or for transporting different foodstuffs at the same time, there must be
effective separation of products to protect against the risk of contamination.

28

5.

6.

7.

Bulk foodstuffs in liquid, granular or powder form must be transported in receptacles
and/or  containers/tankers  reserved  for  the  transport  of  foodstuffs.  Such  containers
must be marked in a clearly visible and indelible fashion, in one or more Community
languages,  to  show  that  they  are  used  for  the  transport  of  foodstuffs,  or  must  be
marked "for foodstuffs only".

Foodstuffs in  conveyances and/or containers must  be  so  placed  and  protected  as  to
minimise the risk of contamination.

Where it is necessary for the purposes of achieving the objectives of this Regulation,
conveyances  and/or  containers  used  for  transporting  foodstuffs  must  be  capable  of
maintaining  foodstuffs  at  appropriate  temperatures  and  designed  to  allow  those
temperatures to be monitored.

CHAPTER V

Equipment requirements

All  articles,  fittings  and  equipment  with  which  food  comes  into  contact  shall  be  kept  clean
and:

(a)

(b)

be  so  constructed,  be  of  such  materials  and  be  kept  in  such  good  order,  repair  and
condition as to avoid any risk of contamination of the food;

with the exception of non-returnable containers and packaging, be so constructed, be
of such materials and be kept in such good order, repair and condition as to enable
them to be kept thoroughly  cleaned and, if necessary, disinfected, sufficient for the
purposes intended;

(c)

be installed in such a manner as to allow adequate cleaning of the surrounding area.

CHAPTER VI

Food waste

1.

2.

3.

Food  waste,  non-edible  by-products  and  other  refuse  must  be  removed  from
rooms where food is present as quickly as possible so as to avoid its accumulation
and to prevent the contamination of food.

Food waste, non-edible by-products and  other  refuse  must  be  deposited  in  closable
containers unless food business operators can demonstrate to the competent authority
that  other  types  of  containers  or  evacuation  systems  used  are  appropriate.  These
containers must be of an appropriate construction, kept in sound condition, be easy to
clean and if necessary disinfect.

Adequate provision must be made for the storage and disposal of food waste, non-
edible by-products and other refuse. Refuse stores must be designed and managed
in  such  a  way  as  to  enable  them  to  be  kept  clean  and,  where  necessary,  free  of
animals and pests.

29

4.

1.

2.

3.

4.

5.

All waste, whether liquid, solid or gaseous, must be disposed of in a hygienic and
environmentally friendly way in accordance  with  Community legislation applicable
to that effect, and must not constitute  a  source of  contamination of the  food, either
directly or indirectly.

CHAPTER VII

Water supply

There must be an adequate supply of potable water as specified in Council Directive
98/83/EC  relating  to  the  quality  of  water  intended  for  human  consumption11.  This
potable  water  must  be  used  whenever  necessary  to  ensure  that  foodstuffs  are  not
contaminated.

Water which is recycled either to be used in processing or as an ingredient must not
present  a  risk  of  contamination  to  the  food  from  microbiological,  chemical  or
physical hazards, and shall be of the same standard as potable water under Directive
98/83/EC, unless the competent authorities in the Member States are satisfied that the
quality of the water cannot affect the wholesomeness of the foodstuff in its finished
form.

Ice which comes into contact with food or which may lead to any contamination of
food must be made from water which meets the specifications referred to in Directive
98/83/EC.  It  must  be  made,  handled  and  stored  under  conditions  which  protect  it
from all contamination.

Steam  used  directly  in  contact  with  food  must  not  contain  any  substance  which
presents a hazard to health or is likely to contaminate the food.

Where  non-potable  water  is  used,  for  example  for  fire  control,  steam  production,
refrigeration and other similar purposes, it must circulate in a separate system and be
identified  as  such.  Non-potable  water  shall  not  connect  with,  or  allow  reflux  into,
potable water systems.

6.            Where heat treatment is applied to foodstuffs in hermetically sealed containers,
it must be ensured that the water used for heating the containers or for cooling
them after heat treatment is not a source of contamination for the foodstuffs.

CHAPTER VIII

Personal hygiene

1.

Every  person  working  in  a  food-handling  area  shall  maintain  a  high  degree  of
personal  cleanliness  and  shall  wear  suitable,  clean  and,  where  necessary  for  the
purposes of achieving the objectives of this Regulation, protective clothing.

11

OJ L 330, 5.12.1998, p. 32.

30

                                                
2.

1.

2.

3.

4.

5.

6.

No  person  suffering  from,  or  known  to  be  a  carrier  of  a  disease  likely  to  be
transmitted through  food or  while afflicted for example with infected wounds, skin
infections,  sores  or  diarrhoea  shall  be  permitted  to  enter  any  food-handling  area  in
any  capacity  if  there  is  any  likelihood  of  directly  or  indirectly  contaminating  food
with  pathogenic  micro-organisms.  Any  person  so  affected  and  employed  in  a  food
business and who is likely  to come into contact with food shall immediately report
illness or symptoms to the food business operator.

CHAPTER IX

Provisions applicable to foodstuffs

No  raw  materials  or  ingredients  shall  be  accepted  by  a  food  business  if  they  are
known  to  be,  or  might  reasonably  be  expected  to  be,  contaminated  with  parasites,
pathogenic  micro-organisms  or  toxic,  decomposed  or  foreign  substances  that,  after
normal sorting and/or preparatory or processing procedures hygienically applied  by
food businesses, they would still be unfit for human consumption.

Raw  materials  and  all  ingredients  stored  in  a  food  business  shall  be  kept  in
appropriate  conditions  designed  to  prevent  harmful  deterioration  and  protect  them
from contamination.

All  food  which  is  handled,  stored,  packaged,  displayed  and  transported  must  be
protected  against  any  contamination  likely  to  render  the  food  unfit  for  human
consumption,  injurious  to  health  or  contaminated  in  such  a  way  that  it  would  be
unreasonable to expect it to be consumed in that state. Adequate procedures must be
in place to ensure pests are controlled.

Raw  materials,  ingredients,  intermediate  products  and  finished  products  likely  to
support the development of pathogenic micro-organisms or the formation of toxins
must  be  kept  at  temperatures  which  would  not  result  in  a  risk  to  health.  The  cold
chain must not be interrupted. However, limited periods outside temperature control
are  permitted  to  accommodate  the  practicalities  of  handling  during  preparation,
transport, storage, display and service of food provided that it does not result in a risk
to  health.  For  processed  foodstuffs  food  businesses  manufacturing,  handling  and
wrapping processed foodstuffs must have suitable rooms large enough for the separate
storage of raw materials from processed material, with sufficient separate refrigerated
storage to prevent contamination.

Where foodstuffs are to be held or served at chilled temperatures they must be cooled
as quickly as possible following the heat-processing stage, or final preparation stage
if  no  heat  process  is  applied,  to  a  temperature  which  would  not  result  in  a  risk  to
health.

The thawing of foodstuffs shall be undertaken in such a way as to minimise the risk
of  development  of  pathogenic  micro-organisms  or  the  formation  of  toxins  in  the
foods.  During  thawing  foods  shall  be  subjected  to  temperatures  which  would  not
result in a risk to health. Where run-off liquid from the thawing process may present
a  risk  to  health  it  must  be  adequately  drained.  Following  thawing,  food  must  be
handled  in  such  a  manner  as  to  minimise  the  risk  of  development  of  pathogenic
micro-organisms or the formation of toxins.

31

7.

8.

1.

2.

3.

4.

Hazardous  and/or  inedible  substances,  including  animal  feedstuffs,  shall  be
adequately labelled and stored in separate and secure containers.

Raw  materials  used  for  the  manufacture  of  processed  products  must  have  been
produced and marketed or imported in accordance with this Regulation.

CHAPTER X

Provisions applicable to the wrapping and packaging of foodstuffs

Measures  shall be taken  to  ensure  that wrapping and  packaging  materials  are  not  a
source  of  contamination  to  foodstuffs.  Wrapping  and  packaging  materials  must  be
manufactured transported and supplied to food businesses in such a manner that they
are protected from any contamination that may present a risk to health.

Wrapping materials must be stored in such a manner that they are not exposed to a
risk of contamination which might be detrimental to food safety.

Wrapping  and  packing  operations  must  be  carried  out  so  as  to  avoid
contamination  of  food.  In  particular,  the  room  where  packaging  operations  are
undertaken must be of sufficient size, construction and design to allow for hygienic
operations.  Packaging  materials  must  be  clean  prior  to  being  brought  into  the
packaging  area  and  used  without  delay.  Where  packaging  materials  are  to  be  lined
with a wrapping material this must be carried out hygienically.

Wrapping and packaging material must only be re-used for foodstuffs if it is made of
materials  that  are  easy  to  clean  and  where  necessary  for  the  purposes  of  food
hygiene, to disinfect.

CHAPTER XI

Special conditions for certain processing operations

1.

Processing by heat treatment

– 

– 

– 

The  food  must  be  processed  in  accordance  with  a  scheduled  heat  treatment
possibly  associated  with  other  methods  to  control  microbiological  hazards;
equipment  for  the  heat-treatment  must  be  fitted  with  all  control  devices
necessary to ensure that an appropriate heat treatment is applied.

If the heat treatment, possibly combined with other hurdles is not sufficient to
ensure  the  stability  of  the  products,  a  rapid  cooling  to  the  specified  storage
temperature must be applied after heating so that the critical temperature zone
for  spore  germination  and  subsequent  growth  is  passed  through  as  rapidly  as
possible.

If  the  heat  treatment  is  applied  before  wrapping,  measures  must  be  taken  to
prevent recontamination of the food after heating and before filling.

32

–  Where  appropriate  and  in  particular  in  the  case  of  cans  and  glass  jars,  the
integrity of the container’s construction and its cleanliness must be confirmed
before filling.

–  Where  the  heat  treatment  is  applied  to  foodstuffs  in  hermetically  sealed
containers  it  must  be  ensured  that  the  water  used  for  cooling  the  containers
after  heat  treatment  is  not  a  source  of  contamination  for  the  foodstuff.
Chemical additives to prevent corrosion of equipment  and containers must be
used in accordance with good practices.

– 

In the case of a continuous heat treatment of liquid food, the mixture of heat-
treated liquid with incompletely heated liquid must be adequately prevented.

2.

Smoking

– 

Fumes and heat must not affect other operations.

–  Materials used for smoke production must be stored and used in such a way as

to avoid contamination of foodstuffs.

– 

The  combustion  for  smoke  production  of  wood  which  is  painted,  varnished,
glued or has undergone any chemical preservation is prohibited.

3.

Salting

Salts used for the treatment of foodstuffs must be clean and must be stored in such a
way as to prevent contamination. Salts may be re-used after cleaning where HACCP
procedures have demonstrated that there is no risk of contamination.

CHAPTER XII

Training

Food business operators shall ensure that food handlers are supervised and instructed and/or
trained in food hygiene matters commensurate with their work activity.

Food  business  operators  shall  ensure  that  those  responsible  for  the  development  and
maintenance  of  the  HACCP  system  or  for  the  introduction  of  the  guides  referred  to  in
Article 6 and 7 of the present Regulation in a food business have received adequate training
in the principles of HACCP and the areas covered by the guides.

33

EXPLANATORY MEMORANDUM

I.

PROCEDURE

1.

2.

3.

On 14 July 2000, the Commission adopted a package of five proposals aiming
to  recast  Community  food  hygiene  legislation  [Document  COM  (2000)  438].
The  proposal  was  submitted  to  the  Council  and  the  European  Parliament  on
24 July 2000 for adoption by co-decision (except proposal 2000/0181, which is
based on Article 37 of the Treaty).

On  15  May  2002,  the  European  Parliament  has  in  first  reading  given  a
favourable opinion on three of the five proposals of the package.

The present proposal amends the second proposal laying down specific hygiene
rules for food of animal origin [document 2000/0179 (COD)] of the package so
as to take into account the amendments of the European Parliament that were
accepted by the Commission.

4. With  regard  to  proposal  2000/0179  (COD),  the  European  Parliament  adopted
122 amendments. Amendments 36, 39, 48, 78, 99, 119, 121, 126, and 127 were
not voted, as they are linguistic.

The  Commission  can  accept  most  of  the  amendments,  wholly  or  in  part,  and
subject to drafting amendments, except amendments 8, 17, 33, 38, 44, 55, 58,
65, 69, 91, 101, 116 and 132.

The  amendments  are  in  bold  and  underlined.  A  number  of  amendments  have
been  reformulated  so  as  to  ensure  consistency  of  the  terminology  used
throughout the proposal. Extensive editorial changes are mentioned below.

Important deletions are indicated using “strikethrough”.

Certain technical changes have been made to the text  to  ensure its  conformity  with
the  Inter-institutional  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.

II.

OBJECTIVES OF THE PROPOSAL

5.

The second proposal of the package aims to establish detailed hygiene rules to
be respected by all food business operators handling food of animal origin.  It
contains the following key-issues:

– 

It applies to unprocessed and processed products of animal origin.

34

– 

– 

– 

It  applies  also  to  products  of  animal  origin  used  in  the  manufacture  of
composite  products  made  from  products  of  plant  origin  and  processed
products of animal origin.

Food  business  operators  may  not  market  products  of  animal  origin
produced in the Community unless they have been processed entirely in
establishments  which  are  registered,  and  where  necessary  approved,  by
the competent authority.

The  competent  authority  shall  not  approve  establishments  unless  an
inspection prior to the commencement of operations has shown that they
satisfy the sanitary conditions set out in this Regulation.

–  Member States may adapt some requirements laid down in the Annex of
this  Regulation  with  a  view 
the  needs  of
establishments  situated  in  regions  suffering  from  special  geographical
constraints and serving only the local market.

to  accommodating 

– 

Food  of  animal  origin  imported  from  third  countries  shall  comply  with
the requirements laid down in this Regulation.

6.

The proposal corresponds to action 8 in the Annex to the White Paper on Food
Safety.

III.

OVERVIEW OF AMENDMENTS OF THE EUROPEAN PARLIAMENT

7.

Technical/editorial amendments

The majority of the proposed amendments aim to improve the proposal from a
technical  and  editorial  point  of  view.  These  amendments  have  largely  been
taken over by the Commission (Amendments concerned: 1-3, partly 7, 9-12,15,
16, 18-32, 34-37, 39-43, 45-54, 56, 57, 59, 61-64, 66-68, 70-77, 80-90, 92-100,
102-110, 113-115, 117, 118, 122-125).

8.

Relation with Regulation 178/2002 (General Food Law)

A number  of  amendments  aim  to  bring  the  proposal  in  line  with  the  recently
adopted Regulation (EC) No 178/2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority and
laying  down  procedures  in  matters  of  food  safety.  These  amendments  have
largely been taken over by the Commission. (Amendments concerned: 4, 6, 14,
60, 78, 79, 111, 112, 119, 120, 121, 126-128).

9.

Scope (Article 1)

Amendment 5  aims to better  define  the scope  by  transferring  elements  of  the
Annexes to the Articles. The Commission has followed this amendment since
its adoption would give more legal certainty to food business operators.

35

10. Definitions (Article 2)

Amendment  6  provides  for  the  definitions  that  are  included  in  Annex  I  to  be
integrated  in  Article  2.  Whilst  the  Commission  agrees  with  the  objective
pursued by this amendment, the amended proposal maintains the definitions in
Annex I since their integration in Article 2 would not increase the transparency
of the text. Instead however, the amended proposal lays down, in Article 8, that
Annex I cannot be amended using the procedure referred to in Article 9.

11. Flexibility (Article 4)

The proposal introduces flexibility for traditional food production, remote areas
and for food businesses. The method for granting flexibility is largely based on
subsidiarity. It will be mainly small businesses taking a profit of this flexibility.

The  need  for  flexibility  is  generally  endorsed.  However,  in  order  to  ensure
consistency with proposal 2000/0178 (COD) on food hygiene, the Commission
believes that amendment 9 should be aligned to the principles provided for in
the European Parliament’s amendment 31 to proposal 2000/0178 (COD). The
amended  proposal  therefore  integrates  the  latter  amendment  rather  than
amendment 9 to proposal 2000/0179 (COD)

12. Procedure for amending the annexes (Article 8)

Amendment  13  aims  to  define  the  procedure  for  the  Commission  to  amend
Annexes.  It  recognises  the  right  of  initiative  of  the  Commission  and  was
therefore accepted. However, point 3 of the amendment contains an obligation
for  the  Commission  to  present  a  report  on  the  implementation  of  the  new
Regulation. That part of amendment 13 was rejected since it does interfere with
the right of initiative of the Commission.

13. Game meat

Many  amendments  (82-97,  129  and  132)  relate  to  the  Section  on  game  and
game meat. Taken together, these amendments do not always seem to ensure a
coherence  presentation  of  that  Section.  The  amended  proposal  aims  therefore
to  improve  from  an  editorial  point  of  view  the  format  of  the  Section,  whilst
taking into account the objectives pursued by the Parliament, and in particular:

– 

– 

– 

To  exclude  from  the  scope  the  private  use  or  the  preparation  of  game
meat for private use, as well as the direct supplies of small quantities of
wild game and game meat to the final consumer or the local retail trade,

To  ensure  that  game  and  game  meat  to  be  placed  on  the  market  is
examined by the competent authority,

To  ensure  that  there  is  enough  flexibility  in  order  to  take  account  of
hunting  traditions  and  practices  that  may  be  different  between  the
Member States.

36

14. Date of entry into force

Amendment 15 makes that the  Regulation enters into  force  on  the  date  of  its
publication  and  applies  "one  year  after  its  entry  into  force".  This  seems  a
realistic approach.

15. Specific requirements in Annex II

The  amendments  to  Annex  II  generally  aim  to  improve  the  proposal  from  a
technical  point  of  view.  Certain  of  these  amendments  risk  however  to  create
unnecessary  burdens  for  small  businesses  or  constitute  an  overlap  with
proposal  2000/0178 
these
amendments. Amendments concerned: 33, 38, 44, 55, 58,65, 69, 91, 101, 116.

(COD).  The  Commission  did  not  accept 

37

2000/0179 (COD)

Amended proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying down specific hygiene rules for food of animal origin

THE EUROPEAN PARLIAMENT AND 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 Commission12,

Having regard to the opinion of the European Economic and Social Committee13,

Having regard to the opinion of the Committee of the Regions14,

Acting in accordance with the procedure laid down in Article 251 of the Treaty15,

Whereas:

(1)

(2)

(3)

(4)

(5)

Regulation of  the  European Parliament and of  the  Council  (EC)  No  …/…  of  …  (on
the hygiene of foodstuffs) lays down the basic hygiene rules to be respected by food
operators in order to ensure food safety.

Certain  food  may  present  specific  hazards  to  human  health  requiring  the  setting  of
specific hygiene rules in order to ensure food safety.

This  is in  particular  the case  for  food of animal origin  in which microbiological  and
chemical hazards have frequently been reported.

In  the  context  of  the  common  agricultural  policy,  specific  health  rules  affecting  the
production  and  placing  on  the  market  of  products  included  in  the  list  contained  in
Annex I to the Treaty have already been established.

These health rules have ensured that barriers to trade for the products concerned were
removed,  thus  contributing  to  the  creation  of  the  internal  market,  whilst  ensuring  a
high level of protection of public health.

12

13

14

15

OJ C …
OJ C …
OJ C …
OJ C …

38

                                                
(6)

These specific rules are contained in a large number of Directives and in particular in:

– 

– 

– 

– 

– 

– 

– 

– 

– 

Council  Directive  64/433/EEC  of  26  June  1964  on  health  conditions  for  the
production  and  marketing  of  fresh  meat16,  as  last  amended  by  Directive
95/23/EC17,

Council  Directive  71/118/EEC  of  15  February  1971  on  health  problems
affecting the production and placing on the market of fresh poultry meat18, as
last amended by Directive 97/79/EC19,

Council  Directive  77/96/EEC  of  21  December  1976  on  the  examination  for
trichinae  (Trichinella  spiralis)  upon  importation  from  third  countries  of  fresh
meat derived from domestic swine20, as last amended by Directive 94/59/EC21,

Council  Directive  77/99/EEC  of  21  December  1976  on  health  problems
affecting  the  production  and  marketing  of  meat  products  and  certain  other
products of animal origin22, as last amended by Directive 97/76/EC23,

Council  Directive  89/437/EEC  of  20  June  1989  on  hygiene  and  health
problems  affecting  the  production  and  the  placing  on  the  market  of  egg
products24, as last amended by Directive 96/23/EC25,

Council  Directive  91/492/EEC  of  15  July  1991  laying  down  the  health
conditions  for  the  production  and  the  placing  on  the  market  of  live  bivalve
molluscs26, as last amended by Directive 97/79/EC,

Council  Directive  91/493/EEC  of  22  July  1991  laying  down  the  health
conditions  for  the  production  and  the  placing  on  the  market  of  fishery
products27, as last amended by Directive 97/79/EC,

Council Directive 91/495/EEC of 27 November 1990 concerning public health
and animal health problems affecting the production and placing on the market
of rabbit meat and farmed game meat28, as last amended by the act of accession
of Austria, Finland and Sweden,

Council  Directive  92/45/EEC  of  16  June  1992  on  public  health  and  animal
health  problems  relating  to  the  killing  of  wild  game  and  the  placing  on  the
market of wild-game meat29, as last amended by Directive 97/79/EC,

16

17

18

19

20

21

22

23

24

25

26

27

28

29

OJ 121, 29.7.1964, p. 2012-2032.
OJ L 243, 11.10.1995, p. 7.
OJ L 55, 8.3.1971, p. 23.
OJ L 24, 30.1.1998, p. 31.
OJ L 26, 31.1.1977, p. 67.
OJ L 315, 8.12.1994, p. 18.
OJ L 26, 31.1.1977, p. 85.
OJ L 10, 16.1.1998, p. 25.
OJ L 212, 22.7.1989, p. 87.
OJ L 125, 23.5.1996, p. 10.
OJ L 268, 24.9.1991, p. 1.
OJ L 268, 24.9.1991, p. 15.
OJ L 268, 24.9.1991, p. 41.
OJ L 268, 14.9.1992, p. 35.

39

                                                
– 

– 

– 

– 

Council Directive 92/46/EEC of 16 June 1992 laying down the health rules for
the  production  and  placing  on  the  market  of  raw  milk,  heat-treated  milk  and
milk-based products30, as last amended by Directive 96/23/EC,

Council  Directive  92/48/EEC  of  16  June  1992  laying  down  the  minimum
hygiene rules applicable to fishery products caught on board certain vessels in
accordance with Article 3(1)(a)(i) of Directive 91/493/EEC31,

Council  Directive  92/118/EEC  of  17  December  1992  laying  down  animal
health and public health requirements  governing trade in and imports into the
Community  of  products  not  subject  to  the  said  requirements  laid  down  in
specific Community rules referred to in Annex A (I) to Directive 89/662/EEC
and,  as  regards  pathogens,  to  Directive  90/425/EEC32,  as  last  amended  by
Commission Decision 1999/724/EC33,

the
Council  Directive  94/65/EC  of  14  December  1994 
requirements for the production and placing on the market of minced meat and
meat preparations34.

laying  down 

(7) With  regard  to  public  health,  these  Directives  contain  common  principles  such  as
those related to the responsibilities of manufacturers of products of animal origin, the
obligations  of  the  competent  authorities,  the  technical  requirements  for  the  structure
and  operation  of  establishments  handling  products  of  animal  origin,  the  hygiene
requirements which must be complied with in these establishments, the procedures for
the  approval  of  establishments,  the  conditions  for  storage  and  transport,  the  health
marking of the products, etc…

(8)

Many of these principles figure in Regulation……(on the hygiene of foodstuffs) and
apply to all food.

(9)

This common basis permits the Directives referred to above to be simplified.

(10)

(11)

These  specific  rules  can  be  further  simplified  by  eliminating  inconsistencies  which
may have arisen since the time of their adoption.

The introduction of the Hazard Analysis Critical Control Points (HACCP)  procedure
obliges food business operators to develop methods to control and reduce or eliminate
biological, chemical or physical hazards.

(12)

The specific hygiene rules should therefore be recast.

(13) The  principal  objective  of  the  recasting  is  to  secure  a  high  level  of  consumer
protection  with  regard  to  food  safety  by  making  food  business  operators
throughout  the  Community  subject  to  the  same  laws  and  by  ensuring  more
transparency.

30

31

32

33

34

OJ L 268, 14.9.1992, p. 1.
OJ L 187, 7.7.1992, p. 41.
OJ L 62, 15.3.1993, p. 49.
OJ L 290, 12.11.1999, p. 32.
OJ L 368, 31.12.1994, p. 10.

40

                                                
(14) Detailed  hygiene  rules  for  products  of  animal  origin  should  therefore  be  maintained

and, where necessary to ensure consumer protection, tightened.

(15)

Primary  production,  including  the  animal  feedingstuffs  sector,  the  transport  of
animals,  slaughter  and  processing  facilities  up  to  the  point  of  retail  sale  must  be
considered  as  interacting  entities  where  animal  health,  animal  welfare  and  public
health are intertwined.

(16)

This requires proper communication between the different stakeholders along the food
chain at all stages of production, processing and distribution.

(17) Microbiological  criteria,  targets  and/or  performance  standards  may  be  laid  down  in
accordance with the appropriate procedures foreseen for the purpose in Regulation …
(on the hygiene of foodstuffs). Pending the setting of new microbiological criteria, the
criteria fixed in the Directives referred to above continue to apply in accordance with
the  provisions  of  Directive  …/…  repealing  certain  Directives  on  the  hygiene  of
foodstuffs  and the  health conditions for  the production and placing on  the  market  of
certain  products  of  animal  origin  intended  for  human  consumption,  and  amending
Directives 89/662/EEC and 91/67/EEC35.

(18) Member States must be given the tools necessary to define specific hygiene rules for
establishments with a limited production capacity  for handling  food of  animal  origin
and which are subject to particular constraints or serve the local market only, provided
the objectives of food safety are not compromised and account is taken of the fact that
a local market may sometimes straddle national borders.

(19)

Imported  food  of  animal  origin  should  meet  at  least  the  same  or  equivalent  health
standards as that produced within the Community, and uniform procedures should be
introduced to ensure that this objective is attained.

(20)

This recast of the existing Community food hygiene rules means that the existing food
hygiene rules can be repealed by Council Directive .../.../EC.

(21)

The products covered by this Regulation are included in Annex I to the Treaty.

(22)

Scientific advice underpins Community legislation on food hygiene.  To  this  end,  the
scientific  committees  in  the  field  of  consumer  protection  and  food  safety  set  up  by
Commission  Decision  97/579/EC  of  23  July  1997(1)  and  the  Scientific  Steering
Committee set up by Commission Decision 97/404/EC of 10 June 1997(2). European
Food  Safety  Authority  set  up  by  Regulation  (EC)  N°  178/2002  of  the  European
Parliament  and  of  the  Council  of  28  January  2002  laying  down  the  general
principles and requirements of food law, establishing the European Food Safety
Authority  and  laying  down  procedures  in  matters  of  food  safety36  should  be
consulted wherever necessary.

35

36

OJ L …
OJ L 31, 1.2.2002, p. 1.

41

                                                
(23)

(24)

In  order  to  take  account  of  technical  and  scientific  progress,  a  procedure  should  be
available to adopt certain requirements called for in this Regulation. There should also
be a procedure  enabling, where necessary, a smooth transition  to  the  required  health
level.

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  Commission37  and  should  therefore  be  adopted  by  use  of  the
regulatory procedure provided for in Article 5 of that Decision,

HAVE ADOPTED THIS REGULATION:

Article 1
Subject matter and scope

This Regulation lays down the specific hygiene rules to ensure the hygiene of food of animal
origin.

1.

This  Regulation  lays  down  specific  hygiene  rules  for  food  business  operators  on
the hygiene of food of animal origin to supplement those laid down in Regulation
(EC) No ../.. [on the hygiene of foodstuffs].

2.            This Regulation applies to:

(a)     unprocessed and processed products of animal origin,

(b)     products of animal origin used in the manufacture of composite products
made  from products  of  plant  origin  and of  processed  products  of  animal
origin.

It shall not apply to:

(a)     the point of retail trade, unless specified otherwise;

(b)     primary production of foodstuffs for the producers own consumption;

(c)      preparation of foodstuffs for the producers own consumption; or

(d)     composite  products  made  from  products  of  plant  origin  and  processed

products of animal origin.

3.            This Regulation applies without prejudice to

(a)     the relevant animal health and hygiene rules laid down for the prevention,
spongiform

transmissible 

eradication 

certain 

of 

control, 
encephalopathies;

and 

37

OJ L 184, 17.7.1999, p. 23.

42

                                                
(b)     the  relevant  rules  on  official  controls  laid  down  in  or  adopted  for  the
implementation  of  Regulation  of  the  European  Parliament  and  of  the
Council (EC) No …/… on official feed and food controls38;

(c)      Regulation of the European Parliament and of the Council (EC) No …/…
laying  down  detailed  rules  for  the  organisation  of  official  controls  on
products of animal origin intended for human consumption39.

Article 2
Definitions

For  the  purpose  of  this  Regulation,  the  definitions  laid  down  in  Regulation  (EC)
N° 178/2002 , Regulation (EC) No …/… (on the hygiene of foodstuffs) and in Annex I to this
Regulation shall apply.

Article 3
Registration and approval of establishments

1.            Food business operators shall not place products of animal origin produced in
the  Community  on  the  market  unless  they  have  been  processed  entirely  in
establishments which:

(a)     fulfil the requirements set out in Annex II and

(b)     are  registered  with  the  competent  authority  and,  where  necessary,  have

been approved in accordance with paragraphs 2 and 3.

2.            Establishments  which  handle  those  products  of  animal  origin  for  which
Annex II  lays  down  requirements,  except  establishments  operating  at  the
primary  production  or  transport  stages,  shall  not  operate  without  prior
approval by the competent authority in accordance with paragraph 3.

3.            Establishments shall not be approved unless an inspection prior to the start-up
of  operations  has  shown  that  they  satisfy  the  conditions  set  out  in  this
Regulation. However, an establishment may be provisionally approved:

(a)     in accordance with Article 3(1) of Regulation (EC) No …/… (laying down
detailed  rules  for  the  organisation  of  official  controls  on  products  of
animal origin intended for human consumption); or

(b)     if  the  establishment  produces  only  small  quantities  of  foodstuffs  and

mainly supplies the local market, pending an on-site inspection.

38

39

OJ L …
OJ L …

43

                                                
Article 4
Imports from third countries

Food of animal origin imported from third countries shall comply with the requirements laid
down in Annex III to the present Regulation.

Article 4
Special arrangements

1.

2.

A  Member  State  may,  in  co-operation  with  the  Commission  and  in  accordance
with the procedure referred to in paragraph 2, adapt the requirements laid down
in Annexe II, provided that the objectives of food hygiene are not compromised, with
a view to:

(a)

(b)

accommodating the needs of food businesses situated in regions suffering from
special  geographical  constraints  or  affected  by  supply  difficulties  which  are
serving the local market, or

take account of traditional methods of production or the use of raw materials
which  are,  according  to  scientific  findings,  established  practice  or
tradition, characteristic of the production process.

Member  States  having  recourse  to  the  possibility  referred  to  in  paragraph 1  shall
notify the Commission and the other Member States and supply them with a list of
products  and  the  regions  concerned  as  well  as  the  adjustments  made  to  adapt
hygiene  rules.  Member  States  may,  within  one  month  of  the  receipt  of  the
notification,  send  written  comments  to  the  Commission.  Where  appropriate,  a
decision shall be taken in accordance with the procedure referred to in Article 9(2).

Article 5
Amending of Annexes and implementing measures

In accordance with the procedure referred to in Article 6,

1.            Provisions in the Annexes to this Regulation may be repealed, amended, adapted or
supplemented in order to take account of the development of codes to good practice,
the  implementation  of  food  safety  programmes  by  food  operators,  new  risk
assessments  and  the  possible  setting  of  food  safety  targets  and/or  performance
standards.

2.            Implementing measures  to  ensure the uniform  implementation  of  the  Annexes  may

be taken.

44

Article 5
Additional guarantees

1.            Consignments of beef, veal and pig meat  including minced meat, poultry  meat
and  eggs  destined  for  Sweden  and  Finland,  shall  have  been  subjected  to  a
microbiological test in respect of salmonella by sampling in the establishment of
origin in accordance with Article 4(6), (7) and (8) of Regulation (EC) No …/…
[on the hygiene of foodstuffs].

2.            The test provided for in paragraph 1 shall not be required for consignments of
beef and veal, pig meat and poultry meat intended for an establishment for the
purposes of pasteurisation, sterilisation or treatment having a similar effect.

3.            The test provided for in paragraph 1 shall not be required for meat originating
in  an  establishment  which  is  subject  to  an  operational  control  programme
approved  by  the  Commission  in  accordance  with  the  procedure  referred  to  in
Article 9(2), as equivalent to that approved for Sweden and Finland.

Article 6
General Obligation

In  addition  to  the  requirements  laid  down  in  Regulation  (EC)  No  …/…  [on  the  hygiene  of
foodstuffs] , food business operators shall ensure that food of  animal origin is obtained and
marketed in accordance with Annex II to this Regulation.

Every substance, excluding potable water, with which products  are  treated in  order to
reduce  hazards,  and  the  conditions  for  its  use,  shall  be  approved  prior  to  its  use  and
following  consultation  of  the  European  Food  Safety  Authority,  in  accordance  with  the
procedure referred to in Article 9(2). The use of these substances shall not prejudice the
correct implementation of this Regulation.

Article 7
Imports from third countries

Without  prejudice  to  the  animal  health  requirements  for  the  importation  of  food  of
animal  origin  laid  down  in  Council  Regulation  …/…  [laying  down  the  animal  health
rules  governing the  production,  placing  on  the  market  and  importation  of  products  of
animal  origin]40,  food  business  operators  shall  ensure  that  food  of  animal  origin  from
third countries is imported in accordance with the requirements laid down in Annex III.

Article 8
Amending of Annexes and implementing measures

1.

The  provisions  of  Annex  II  may  be  amended  in  accordance  with  the  procedure
referred to in Article 9(2) in order to take account of:

– 

the development of guides to good practice,

40

OJ L …

45

                                                
– 

– 

– 

the implementation of food safety programmes by food operators,

new risk assessments and opinions of the European Food Safety Authority, and

the possible setting of food safety targets and/or performance standards.

2.

Implementing measures to ensure uniform implementation of the Annexes shall be
adopted in accordance with the procedure referred to in Article 9(2).

Article 9
Standing Committee Procedure

1.            The Commission shall be assisted by the Standing Veterinary Committee , instituted

by Council Decision 68/361/EEC41.

1.            The  Commission  shall  be  assisted  by  the  Standing  Committee  on  the  Food
Chain  and  Animal  Health  set  up  under  Article  58  of  Regulation  (EC)  No
178/2002.

2.

3.

Where  reference  is  made  to  this  paragraph,  Articles  5  and  7  of  Decision
1999/468/EC shall apply, in compliance with Article 8 thereof.

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

Article 10

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

It shall apply from 1 January 2004 from DD/MM/YY.

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

41

OJ L 225, 18.10.1968, p. 23.

46

                                                
ANNEX I

DEFINITIONS

1.

MEAT

1.1 meat:  all  parts  of  animals  which  are  fit  for  human  consumption,  including

blood;

1.1.1 meat of domestic ungulates: meat of domestic bovine (including Bubalus
and  Bison  species),  porcine,  ovine  and  caprine  animals,  and  domestic
solipeds;

1.1.2 poultry-meat:  meat  of  farmed  birds  including  birds  which  are  not
considered  as  domestic  but  which  are  farmed  as  domestic  animals
(farmed game birds);

1.1.3 meat of lagomorphs: meat of rabbits, hares and rodents farmed for human

consumption

1.1.4 wild- game meat: meat of:

– 

wild land mammals which are hunted, including mammals living in
enclosed  territory  under  conditions  of  freedom  similar  to  those  of
wild game;

– 

wild birds which are hunted;

1.2

1.3

1.4

1.5

1.1.5 farmed  game  meat:  meat  of  farmed  even-toed  ungulate  game  mammals

(including Cervidae and Suidae) and of farmed ratites;

large wild game: wild mammals of the Orders Artiodactyla, Perissodactyla and
Marsupialia, as well as other mammal species classified under national hunting
legislation as large game;

small  wild  game:  wild  game  birds  and  wild  game  mammals  not  classified  as
large game;

carcase  (domestic  ungulates):  the  whole  body  of  a  slaughtered  domestic
ungulate after bleeding, evisceration and removal of the limbs at the carpus and
the  tarsus,  removal  of  the  head,  tail  and  where  appropriate  the  udder,  and  in
addition, in the case of bovine animals, sheep, goats and solipeds, after flaying;

carcase  (poultry):  the  whole  body  of  a  bird  after  bleeding,  plucking  and
evisceration;  however,  removal  of  the  heart,  liver,  lungs,  gizzard,  crop  and
kidneys, sectioning of the legs at the tarsus and removal of the head, oesophagus
or trachea are optional;

1.6 New-York dressed poultry: poultry carcases for which the evisceration has been

deferred;

47

1.7

1.8

1.9

fresh  meat:  meat,  including  meat  which  is  vacuum-wrapped  or  wrapped  in  a
controlled  atmosphere,  which  has  not  undergone  any  preserving  process  other
than chilling, freezing or quick-freezing to ensure preservation;

offals: meat other than that of the carcase even if it remains naturally connected
to the carcase;

viscera:  offal  from  the  thoracic,  abdominal  and  pelvic  cavities,  including  the
trachea and oesophagus, and in birds the crop;

1.10 slaughterhouse: an establishment for slaughtering animals, the meat of which is
intended  for  sale  for  human  consumption,  including  any  place  available  in
connection  therewith  for  the  confinement  of  animals  while  awaiting  slaughter
there;

1.11 cutting plant: an establishment used for boning and/or cutting up carcases, parts
of carcases and other edible parts of animals including premises adjacent to sale
points where these operations are carried out for supplying the consumer or other
sale points;

1.12 game collection centre: an establishment where killed wild game is kept prior to

being transported to a game handling establishment;

1.13 game  processing  handling  establishment:  an  establishment  for  the  handling
skinning of game obtained after hunting, with the aim of obtaining meat from
wild game animals for commercial purposes;

1.14 minced  meat:  boned  meat  which  has  been  reduced  into  fragments  or  passed

through a spiral screw mincer;

1.15 mechanically separated meat: product resulting from the mechanical separation
of meat left on the bones after boning, so that the cellular structure of the meat is
broken;

1.16 meat preparations: fresh meat including minced meat which has had foodstuffs,
seasonings  or  additives  added  to  it  or  which  has  undergone  a  treatment
insufficient  to  modify  the  internal  cellular  structure  of  the  meat  and  thus  to
eliminate the characteristics of the fresh meat;

2.

LIVE BIVALVE MOLLUSCS

2.1

bivalve  molluscs:  filter-feeding  lamellibranch  molluscs,  and  by  extension,
echinoderms, tunicates and marine gastropods;

2.2 marine  biotoxins:  poisonous  substances  accumulated  by  bivalve  molluscs

feeding on plankton containing toxins;

2.3

conditioning: the storage of live bivalve molluscs coming from a class A areas, a
purification centre where they have been purified or a dispatch centre, in
tanks  or  any  other  installation  containing  clean  sea  water  or  in  natural  sites  to
remove  sand,  mud  or  slime,  to  improve  organoleptic  qualities  and  to  ensure
that they are in a good state of vitality before packaging;

48

2.4

2.5

2.6

2.7

2.8

2.9

gatherer: any natural or legal person who collects live bivalve molluscs by any
means  from  a  harvesting  area  for  the  purpose  of  handling  and  placing  on  the
market;

production  area:  any  sea,  estuarine  or  lagoon  area  containing  natural  beds  of
bivalve  molluscs  or  sites  used  for  cultivation  of  bivalve  molluscs  from  which
live bivalve molluscs are taken;

relaying  area:  any  sea,  estuarine  or  lagoon  area  approved  by  the  competent
authority, with boundaries clearly marked and indicated by buoys, posts or any
other  fixed  means,  and  used  exclusively  for  the  natural  purification  of  live
bivalve molluscs;

dispatch  centre:  any  approved  on-shore  or  off-shore  installation  for  the
reception, conditioning, washing, cleaning, grading and wrapping of live bivalve
molluscs fit for human consumption;

purification centre: an approved establishment with tanks fed by clean sea water
in  which  live  bivalve  molluscs  are  placed  for  the  time  necessary  to  remove
microbiological contamination, so making them fit for human consumption;

relaying: an operation whereby live bivalve molluscs are transferred to approved
sea, lagoon or estuarine areas under the supervision of the  competent  authority
for  the  time  necessary  to  remove  contamination.  This  does  not  include  the
specific  operation  of  transferring  bivalve  molluscs  to  areas  more  suitable  for
further growth or fattening;

2.10 faecal  coliform: 

facultative  aerobic,  gram-negative,  non-sporeforming,
cytochrome  oxidase  negative,  rod-shaped  bacteria  that  are  able  to  ferment
lactose with gas production in the presence of bile salts, or other surface active
agents  with  similar  growth-inhibiting  properties,  at  44°C  +  0.2°C  within
24 hours;

2.11 E.  coli:  faecal  coliform  which  also  forms  indole  from  tryptophan  at  44°C

+ 0.2°C within 24 hours;

2.12 clean  seawater: sea water,  brackish  water  or  seawater  preparations  made  from
fresh water, free from microbiological contamination, objectionable substances
and/or  toxic  marine  plankton  in  such  quantities  likely  to  adversely  affect  the
health  quality  of  bivalve  molluscs  and  fishery  products.  Where  supply
conditions  justify  it,  this water  shall  be  cleaned  by  means  of  appropriate
treatment.

3.

FISHERY PRODUCTS

3.1

fishery products: all seawater or freshwater animals, wild or farmed, other than
live  bivalve  molluscs,  aquatic  mammals  and  frogs,  or  parts  of  these  animals
including their roes and livers;

49

3.2

3.3

3.4

aquaculture  products:  all  fishery  products  born  and  raised  in  controlled
conditions  until  placed  on  the  market  as  a  foodstuff  as  well  as  seawater  or
freshwater fish or crustaceans caught in their natural environment when juvenile
and kept  until  they  reach  the  desired  commercial  size  for  human  consumption.
Fish and crustaceans of commercial size caught in their natural environment and
kept alive to be sold at a later date are not considered to be aquaculture products
if  they  are merely  kept  alive  without  any  attempt  being  made  to  increase  their
size or weight;

factory vessel: any vessel, fishing or not, on which fishery products undergo one
or  more  of  the  following  operations  followed  by  wrapping:  filleting,  slicing,
skinning, mincing, or processing; fishing vessels in which only crustaceans and
molluscs are cooked on board are not deemed to be factory-vessels;

freezer  vessel:  any  vessel,  fishing  or  not,  on  board  which  freezing  of  fishery
products  is  carried  out,  where  appropriate  after  preparatory  work  such  as
bleeding,  heading,  gutting  and  removal  of  fins.  Where  necessary,  these
operations are followed by wrapping and/or packaging;

3.5 mechanically  recovered  fish  flesh:  flesh  obtained  by  mechanical  means  from

gutted whole fish or bones after filleting;

3.6

clean seawater: see definition at point 2.12;

3.7

clean  river  or  lake  water:  river  or  lake  water  free  from  microbiological
contamination  or  any  objectionable  substances  in  quantities  likely  to  adversely
affect the health quality of fishery products.

4.

EGGS

4.1

eggs: eggs of birds in shell, fit for direct consumption or for the preparation of
egg products, other than broken, incubated or cooked eggs;

4.2

liquid egg: untreated egg contents after removal of the shell;

4.3

egg  production  farm:  farm  for  the  production  of  eggs  intended  to  human
consumption;

4.4

cracked eggs: eggs with a damaged but unbroken shell, with intact membranes.

5.

MILK

5.1 milk: the lactic secretion of the mammary gland free of colostrum;

5.2

raw milk: the unmodified secretion of the mammary glands of production
animals  which  has  not  been  heated  beyond  40°C  or  undergone  any
treatment having an equivalent effect;

raw  milk:  milk  which  has  not  been  heated  beyond  40°C;  treatments  such  as
homogenisation and standardisation which have an effect on the quality of the
milk may be carried out;

50

5.3 milk  production  holding:  holding  in  which  one  or  more  production  animals
cows,  ewes,  goats,  buffaloes  or  females  of  other  species  are  kept  to  supply
milk;

5.4

dairy  establishment:  an  establishment  for  the  processing  of  milk,  or  for  the
further processing of already processed milk.

6.

FROGS’ LEGS AND SNAILS

6.1

6.2

frogs'  legs:  posterior  part  of  the  body  divided  by  a  transverse  cut  behind  the
front limbs, eviscerated and skinned, of the species Rana (family Ranidae);

snails: terrestrial gastropods of the species Helix pomatia Linné, Helix aspersa
Muller, Helix lucorum and species of the family Achatinidae.

7.

PROCESSED PRODUCTS

7.1     processed  product:  foodstuff  resulting  from  the  application  to  unprocessed
products  of  a  treatment  such  as  heating,  smoking,  curing,  maturing,  drying,
marinating etc or a combination of these processes and/or products; substances
necessary  for  their  manufacture  or  for  giving  specific  characteristics  to  the
products may be added;

7.1 meat products: products resulting from the application of a treatment to meat;

7.2

processed fish products: fishery products to which a treatment has been applied;

7.3

egg products: products resulting from the application of a treatment to eggs or to
the  various  components  or  mixtures  thereof  after  removal  of  the  shell  and
membranes.  They  may  be  partially  supplemented  by  other  foodstuffs  or
additives.  They  may  be  liquid,  concentrated,  dried,  crystallised,  frozen,  quick-
frozen or coagulated.

7.4 milk  products:  products  resulting  from  the  application  to  raw  milk  of  a
treatment,  such  as  heat-treated  drinking  milk,  milk  powder,  whey,  butter,
cheese, yoghurt (whether or not with acid, salt, spices or fruits added) and re-
constituted drinking milk;

7.5

7.6

7.7

7.8

rendered  animal  fat:  fat  derived  from  rendering  meat,  including  bones,  and
intended for human consumption;

greaves:  the  protein-containing  residue  of  rendering,  after  partial  separation  of
fat and water;

gelatine: natural, soluble protein, gelling or non-gelling, obtained by the partial
hydrolysis  of  collagen  produced  from  bones,  hides  and  skins,  tendons  and
sinews of animals (including fish and poultry);

treated  stomachs,  bladders  and  intestines:  stomachs,  bladders  and  intestines
which  have  been  submitted  to  a  treatment  such  as  salting,  heating  or  drying
after they have been obtained and after cleaning.

51

8.

OTHER DEFINITIONS

8.1

8.2

composite  product:  a  foodstuff  containing  products,  whether  unprocessed  or
processed, of animal and plant origin;

re-wrapping:  the  removal  of  the  original  wrapping  from  the  product  for
replacing it by a new wrapping, possibly after having applied to the unwrapped
product physical operations such as cutting or slicing;

8.3 wholesale market: means a food business which includes several separate units
which  share  common  installations  and  sections  where  foodstuffs  are  sold  to
food businesses and not to the final consumer.

52

ANNEX II

SPECIFIC REQUIREMENTS

MARKING Preface

1.            This  Annex  applies  to  unprocessed  and  processed  products  of  animal  origin.
Composite  products  are  not  subject  to  the  requirements  of  the  present  Annex.
However,  it  must  be  ensured  that  possible  hazards  resulting  from  the  use  of
ingredients  of  animal  origin  are  identified  and  controlled,  and  where  necessary
eliminated or reduced to acceptable levels.

2.            Unless specified otherwise, the requirements laid down in this Annex shall not apply

to the point of retail trade.

1.

Where  approval  of  establishments  as  referred  to  in  Article  3  is  required  the  present
Annex, the following shall apply:

(a) 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.

(b) Member States shall maintain up-to-date lists of approved establishments with

their respective approval numbers.

In addition to the above, the approval is also required for wholesale markets where
unprocessed or processed products of animal origin are handled.

2.

Where  required  under  the  present  Annex,  products  of  animal  origin  shall  carry  an
oval health mark in accordance with the following rules:

(a)

The  health  mark  shall  be  applied  during  or  immediately  after  manufacture  in
the establishment in such a way that it cannot be re-used.

(b) The  health  mark  must  be  legible,  indelible  and  the  characters  must  be  easily
decipherable; it must be clearly displayed for the controlling authorities.

(c)

The health mark shall carry at least the following information:

– 

the name of the country of dispatch, which may be written out in full or
shown as an abbreviation as follows:

A, B, DK, D, EL, E, F, FIN, IRL, I, L, NL, P, S, UK,

– 

the approval number of the establishment,

53

(d) The  health  mark  may,  depending  on  the  presentation  of  different  products  of
animal  origin,  be  applied  directly  to  the  product,  the  wrapping  or  the
packaging, or be printed on a label affixed to the product, the wrapping or the
packaging. The health mark may also be an irremovable tag made of a resistant
material.

For products of animal origin which are placed in transport containers or large
packages and intended for further handling, processing or wrapping in another
establishment,  the  health  mark  may  be  applied  to  the  external  surface  of  the
container or packaging. In this event, the recipient food operator must maintain
a  record  of  the  quantities,  type,  origin  and  the  destination  of  the  products  of
animal origin;

(e)

The health marking of individual products of animal origin contained in a retail
sale unit is not necessary if the health mark is applied to the external surface of
that retail sales unit.

(f) When  the  health  mark  is  applied  directly  to  products  of  animal  origin,  the
colours  used  shall  be  authorised  in  accordance  with  Community  rules  on  the
use of colouring substances in foodstuffs.

(g)

If  products  of  animal  origin  are  unwrapped  and  subsequently  re-wrapped,
handled or further processed in another establishment, the latter establishment
must  be  approved  and  apply  its  own  health  mark  to  the  product.  The
accompanying  documents  must  specify  the  original  establishment  of
manufacture or the previous supplier establishment.

Products to which the above health mark must not be applied shall carry a mark
that allows the origin of the products to be traced and that is distinctly different
from the oval health mark.

5.            Any substance other than potable water applied to products for hazard reduction, as
well as their conditions for use, must be approved in accordance with the procedure
referred  to  in  Article  6,  after  the  opinion  of  the  Scientific  Committee.  The
implementation  of  this  paragraph  shall  be  without  prejudice  to  the  correct
implementation of the requirements of the present Regulation

6.            Where  necessary,  special  conditions  may  be  granted  by  the  competent  authority  in

particular in order to take account of traditional production methods.

7.            The present Annex shall apply without prejudice to the relevant animal health rules
and  without  prejudice  to  more  stringent  rules  laid  down  for  the  prevention  and
control of certain transmissible spongiform encephalopathies.

SECTION I: MEAT OF DOMESTIC UNGULATES

The animals, or where appropriate each batch of animals sent for slaughter must be identified
so that its origin can be traced.

Animals  may  not  come  from  a  holding  or  an  area  subject  to  a  movement  prohibition  for
reasons of animal health unless permitted by the competent authority.

54

CHAPTER I: CONDITIONS FOR SLAUGHTERHOUSES

Slaughterhouses  must  be  constructed  and  equipped  in  accordance  with  the  following
conditions:

1.

They  must  have  adequate  and  hygienic  lairage  facilities  or,  climate  permitting,
waiting pens which are easy to clean and disinfect. These facilities must be equipped
for  watering  the  animals  and  feeding  them  if  necessary.  The  drainage  of  the
wastewater must not compromise food safety.

Where  considered  necessary  by  the  competent  authority,  They  must  also  have
separate lockable lairage facilities premises or  climate  permitting,  pens  for  sick  or
suspect  animals  with  separate  draining  and  sited  in  such  a  way  as  to  avoid
contamination of other  animals  except  where  the  competent  authorities  consider
them to be unnecessary.

The size of the lairage facilities must enable to ensure the  respect of the welfare of
the  animals.  Their  lay-out  must  facilitate  ante-mortem  inspections  including  the
identification of the animals or groups of animals.

2.

Have  a  slaughter  room  and  where  appropriate  a  sufficient  number  of  rooms
appropriate to the operations being carried out and be constructed in such a way as to
avoid contamination of the meat as much as possible by ensuring that:

(a)

there is a distinctly separated area for stunning and bleeding;

(b)

(c)

in  the  case  of  pig  slaughtering,  there  is  a  separation  of  scalding,  depilation,
scraping and singeing operations of pigs from other operations;

there  are  installations  ensuring  that  there  is  no  contact  between  the  meat  and
the floors, walls or equipment;

in  the  case  of  small-scale  slaughter  and  single-place  slaughter,  these
installations must be designed in such a way that operations can, wherever
possible,  be  carried  out  on  the  hanging  animal;  there  shall  in  no  way  be
contact with the floor;

(d) where  slaughter  lines  are  operated,  these  are  designed  to  allow  a  constant
progress  of  the  slaughter  process  and  avoid  cross-contamination  between  the
different parts of the slaughter line;

where  more  than  one  slaughter  lines  is  are  operated  in  the  same  premises,
adequate  separation  of  these  lines  is  ensured  in  order  to  prevent  cross-
contamination;

55

(e)

the following operations are carried out separately from the operations during
which meat is obtained:

– 

– 

– 

emptying  stomachs  and  intestines;  in  slaughterhouses  with  a  limited
throughput  unless  the  competent  authority  may  allow  the  cleaning  of
stomachs  and  intestines  gives  permission  on  a  case-by-case  basis  for
these operations to be carried out in the slaughter room at times when
no  slaughtering  is  taking  place  different  times  from  the  slaughter
activity;

further  handling  of  guts  and  tripe,  if  this  is  carried  out  in  the
slaughterhouse;

preparation and cleaning of other offal; skinned heads must be handled at
a  sufficient  distance  from  meat  and  other  offal,  if  these  operations  are
carried  out  in  the  slaughterhouse  and  do  not  take  place  at  the  slaughter
line;

(f)

there  is  a  separate  place  for  packaging  offal  if  this  is  done  in  the
slaughterhouse;

(g)

there is an appropriate area, sufficiently protected, for dispatching meat.

They  must  have  facilities  for  disinfecting  tools  with  hot  water  supplied  at  not  less
than 82°, or an alternative system having an equivalent effect.

The  equipment  for  washing  hands  used  by  the  staff  engaged  in  handling  exposed
meat shall be provided with taps that are non-hand operable.

Lockable  premises  must  be  provided  for  the  refrigerated  storage  of  detained  meat
and for the storage of meat declared unfit for human consumption.

There  must  be  a  separate  place  with  appropriate  facilities  for  the  cleaning  and
disinfection  of  means  of  transport  of  livestock.  These  places  and  facilities  are  not
compulsory if officially authorised places and facilities exist nearby.

They  must  have  lockable  premises  reserved  for  the  slaughter  of  sick  and  suspect
animals.  This  is  not  essential  if  this  slaughter  takes  place  in  other  establishments
authorised  by  the competent  authority  for  this purpose, or  at  the  end  of  the  normal
slaughter  period.  The  premises  must  be  cleaned  and  disinfected  under  official
supervision before slaughter is resumed.

If manure and stomach or gut content is stored in the slaughterhouse precincts, they
must have a special area or place for that purpose.

They  must  have  suitably  equipped  lockable  facilities  or,  where  necessary,  a
room for the use of the veterinary service only.

3.

4.

5.

6.

7.

8.

9.

56

10.

All operations for the slaughter of reindeer destined for intra-Community trade
may be carried out in mobile slaughter units in accordance with the provisions
for meat of domestic ungulates. Once the European Food Safety Authority has
given  its  opinion,  the  conditions  under  which  mobile  slaughterhouses  can  be
used for the slaughter of other species shall be laid down.

CHAPTER II: CONDITIONS FOR CUTTING PLANTS

Cutting plants must:

1.

2.

3.

4.

5.

1.

2.

3.

Be  constructed  so  as  to  allow  constant  progress  of  the  operations  and  precautions
must be taken to avoid cross contamination of meat. or ensure separation between
the different production batches.

Have  rooms  for  the  separate  storage  of  packed  and  exposed  meat,  unless  stored  at
different times.

Have cutting rooms equipped to ensure that the cold chain is not interrupted during
cutting  operations  so  as  to  satisfy  the  temperature  requirements  laid  down  in
Chapter IV of this Section.

Have equipment for washing hands provided with taps that are non-hand operable to
be used by the staff engaged in handling exposed meat.

They  must  have  facilities  for  disinfecting  tools  with  hot  water  supplied  at  not  less
than 82°, or an alternative system having an equivalent effect.

CHAPTER III: SLAUGHTER HYGIENE

After arrival in the slaughterhouse, the slaughter of the animals shall not be unduly
delayed.  However,  where  required  for  welfare  reasons,  animals  must  be  given  a
resting  period  before  slaughter.  Only  live  animals  intended  for  slaughter  may  be
brought  into  the  slaughter  premises,  with  the  exception  of  animals  that  have
undergone emergency slaughter outside the slaughterhouse, farmed game slaughtered
at the place of production and wild game.

Animals which die have died during transport or before stunning or bleeding in the
lairages shall not be used for human consumption.

The animals must be clean. The state of cleanliness of the animals must be such as
not  to  present  an  unnecessary  risk  of  contaminating  the  meat  during  slaughter
operations.

Before slaughter, animals must, in accordance with the rules laid down in Regulation
(EC)  No  …/…  (laying  down  detailed  hygiene  rules  for  food  of  animal  origin),  be
presented  to  a  veterinarian  designated  by  the  competent  authority  in  order  to  be
submitted  to  an  ante-mortem  inspection.  Slaughterhouse  operators  shall  follow  the
instructions  of  the  competent  authority  in  order  to  ensure  that  the  ante-mortem
inspection is carried out under suitable conditions.

57

4.

5.

Slaughter animals brought into the slaughter hall must be slaughtered without undue
delay.

Stunning, bleeding, skinning, dressing  and evisceration must be carried out without
undue  delay  in  such  a  way  that  contamination  of  the  meat  is  avoided.  It  must  in
particular be ensured that,

– 

– 

– 

– 

the trachea and oesophagus remain intact during bleeding, except in the case of
ritual slaughter according to religious custom.

during the removal of hides and fleece, contact between the outside of the skin
and  the  carcase  is  prevented,  and  that  operators  and  equipment  coming  into
contact with the outer surface of hides and fleece do not touch the meat.

measures  are  taken  to  prevent  the  spillage  of  digestive  tract  contents  during
evisceration  and  that  evisceration  is  completed  as  soon  as  possible  after
stunning.

removal of the udder does not result in contamination of the carcase with milk
or colostrum.

6.

Skinning must be complete, except in the case of pigs; however, the skinning of the
head is not required

7.

8.

9.

– 

– 

in the case of heads of calves and ovines, provided that such heads are handled
so as to avoid contamination of meat

if  such  heads,  including  tongues  and  brains,  are  not  intended  for  human
consumption.

When  not  skinned,  pigs  must  have  their  bristles  removed  immediately.  The  risk  of
contamination  of  the  meat  with  scalding  water  must  minimised.  Only  approved
additives  may  be  used  for  this  operation  provided  that  pigs  are  thoroughly  rinsed
afterwards with potable water.

The  carcases  must  not  contain  visible  faecal  contamination.  Any  visible
contamination must be removed by trimming.

Carcases and offal shall not come into contact with floors, walls or work stands.

Slaughtered  animals  must  be  presented  to  the  competent  authority  in  order  to  be
submitted  to  a  post-mortem  inspection.  Slaughterhouse  operators  shall  follow  the
instructions  of  the  competent  authority  in  order  to  ensure  that  the  post-mortem
inspection is carried out under suitable conditions.

Parts  of  the  slaughtered  animals  that  have  been  removed  before  the  post  mortem
inspection  is  performed,  must  remain  identifiable  as  belonging  to  a  given  carcase.
However,  provided  it  shows  no  pathological  symptom  or  lesion,  the  penis  may  be
discarded immediately.

Both kidneys must be removed from their fatty covering and peri-renal capsule.

58

If  the  blood  or  offals  of  several  animals  are  collected  in  the  same  container  before
completion of the post mortem inspection, the entire contents must be declared unfit
for human consumption if the carcase of one or more of the animals concerned has
been declared unfit for human consumption.

Carcases  and offal  shall  not  come  into  contact  with  each  other  before  post-mortem
inspection is finalised.

10.

After post mortem inspection,

– 

– 

– 

– 

the tonsils of bovine animals under six weeks, and pigs and solipeds must be
removed hygienically,

the parts unfit for human consumption must be removed as soon as possible at
once from the clean sector of the establishment,

meat  detained  or  declared  unfit  for  human  consumption  and  inedible
by-products  must  not  come  into  contact  with  meat  declared  fit  for  human
consumption.

viscera or parts of viscera which have not been removed from the carcase before
post-mortem  inspection,  except  for  the  kidneys  or  unless  specified  elsewhere,
must be removed entirely if possible and as quickly as possible.

After completion of slaughter and post-mortem inspection procedures, the meat must
be stored in accordance with the requirements laid down in Chapter IX of the present
Section.

Where establishments are approved for the slaughter of different animal species or for
the handling of carcases of farmed game and wild game, precautions must be taken to
prevent cross-contamination by separation either in time or in space of the operations
carried out on the different species. Separate facilities for the reception and storage of
carcases of farmed game slaughtered at the farm and for wild game must be available.

CHAPTER IV: HYGIENE DURING CUTTING AND BONING

Carcases of domestic ungulates may be cut into half-carcases, and half-carcases into
quarters or a maximum of three pieces in approved slaughterhouses. Further cutting
and boning must be carried out in a cutting plant.

The  work  on  meat  must  be  organised  in  such  a  way  as  to  prevent  the  growth  of
pathogenic micro-organisms or the formation of toxins or other pathogenic substances,
and in particular:

(a) Meat intended for cutting must be brought into the work rooms progressively

as needed.

11.

12.

1.

2.

59

(b) During cutting, boning, slicing, dicing, wrapping and packaging, the cooling of

the meat must not be interrupted.

Where meat is boned and cut prior to reaching the temperatures for storage and
transport provided for in Chapter IX of the present Section, such meat must be
transferred directly from the slaughter premises to the cutting room, or after a
waiting  period  in  the  cold  store.  As  soon  as  it  is  cut  and  where  appropriate
packaged, the meat must be chilled to 7°C for carcase meat and 3°C offals

(c) Where the premises  are  approved  for  the  cutting  of  meat  of  different  species,
precautions  must  be  taken  to  avoid  cross-contamination,  where  necessary  by
separation of the operations of the different species in either space or time.

CHAPTER V: SPECIAL CONDITIONS

Member  States  may  adapt  the  requirements  laid  down  in  Chapters  I  and  II  with  a  view  to
accommodate  the  needs  of  establishments  situated  in  regions  suffering  from  special
geographical constraints or affected by supply difficulties, or those serving the local market.
Hygiene shall not be compromised. The Member States shall inform the Commission of the
details of such special conditions.

Establishments  serving  the  local  market  shall  mean  slaughterhouses  and  cutting  plants
marketing  their  meat  in  the  vicinity  of  the  place  where  such  slaughterhouses  and  cutting
plants are situated.

1.

2.

CHAPTER V: CASUALTY AND EMERGENCY SLAUGHTER

Meat  from  animals  that  have  undergone  emergency  slaughter  following  serious
physiological or functional problems is not authorised for human consumption.

the
Meat  from  animals 
slaughterhouse  following  an  accident  is  authorised  for  human  consumption  on  the
local market if the following requirements are fulfilled:

that  have  undergone  emergency  slaughter  outside 

– 

– 

– 

the animal is examined by a veterinarian before slaughter; however, the animal
may  be  slaughtered  before  examination  by  a  veterinarian  when  required  for
welfare reasons,

the animal is slaughtered after  stunning,  bled  and  possibly  eviscerated  on  the
spot; the veterinarian may authorise shooting in special cases,

the  slaughtered  and  bled  animal  is  transported  as  quickly  as  possible  after
slaughter  under  satisfactory  hygiene  conditions  to  a  slaughterhouse  approved
for  that  purpose.  Where  the  slaughtered  animal  cannot  be  brought  to  such  a
slaughterhouse within two hours an hour, it must be transported in a container
or means of transport in which the ambient temperature is maintained between
0°C  and  4°C.  Evisceration  must  be  carried  out  as  soon  as  possible.  If  an
excessively long period elapses between slaughter and evisceration, the official
veterinarian  may  require  that  special  checks  are  carried  out  at  post-mortem
inspection.  If  evisceration  is  carried  out  on  the  spot,  the  viscera  must
accompany the carcase to the slaughterhouse.

60

– 

– 

– 

during  transport  to  the  slaughterhouse,  the  slaughtered  animal  and  where
appropriate the viscera are transported hygienically and are accompanied by a
certificate issued by the veterinary surgeon who has ordered slaughter attesting
to  the  outcome  of  the  ante-mortem  inspection,  the  time  of  slaughter  and  the
nature  of  any  treatment  administered  to  the  animal  and,  if  appropriate,  the
result of the inspection of the viscera.

the slaughtered animal is declared wholly or partly fit for human consumption
after  having  been  submitted  to  a  detailed  post  mortem  examination,  where
necessary supplemented by a bacteriological and residue examination.

The meat is not provided with the health mark but with an identification mark
approved by the competent authority.

3.            Meat from animals that have undergone emergency slaughter following an accident
in  a  slaughterhouse  may  be  marketed  if  the  animals  have  been  submitted  to  an
examination before slaughter, if no other serious lesions than  those  which occurred
immediately before slaughter have been found and if it has been declared wholly or
partly  fit  for  human  consumption  after  having  been  submitted  to  a  detailed  post
mortem examination.

CHAPTER VII: APPROVAL AND REGISTRATION OF ESTABLISHMENTS

Slaughterhouses, cutting plants and cold stores must be approved by the competent authority
and  be  given  an  approval  number.  However,  low  capacity  establishments  distributing  their
products on the local market only may be registered. Such establishments shall not apply the
health mark referred to in Chapter VIII.

1.

2.

3.

4.

CHAPTER VI: HEALTH MARKING

Marking  of  meat  must  be  carried  out  under  the  responsibility  of  an  official
veterinarian,  who  for  this  purpose,  must  supervise  the  marking  and  keep  under  his
control  the  health  stamp  to  be  applied  to  the  meat  which  must  be  handed  over  to
auxiliaries or designated plant employees at the time of marking and for the length of
time required for this purpose.

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  that
establishment’s own number.

After completion of the post mortem inspection, carcases, half carcases, quarters and
carcases cut into three pieces must be stamped in ink or hot-branded on their external
surface so as to ensure that the slaughterhouse of origin is easily identifiable.

Livers must be hot-branded, unless wrapped or packaged.

In the case of cut meat and packaged  cut offal obtained in a cutting plant the mark
must  be  applied  to  a  label  fixed  to  the  packaging,  or  printed  on  the  packaging.
However,  when  cut  meat  or  offal  is  wrapped,  the  label  may  be  affixed  to  the
wrapping in such a way that the label is destroyed when the wrapping is opened.

61

5.

1.

2.

3.

4.

5.

6.

The  health  mark  may  include  an  indication  of  the  official  veterinarian  who  carried
out the health inspection of the meat.

CHAPTER VII: STORAGE, TRANSPORT AND MATURATION

Except  where  warm  cutting  and  boning  is  practiced,  meat  must  be  chilled  after
post-mortem inspection to an internal temperature of not more than 7°C for carcase
meat and 3°C for offal along a chilling curve which ensures  a constant decrease of
the temperature. During the chilling operations, there must be adequate ventilation in
order to prevent condensation on the surface of the meat.

For technical reasons relating to maturation of the meat, a derogation may be granted
on  a  case-by-case  basis  for  the  transportation  of  meat  to  cutting  plants  or  butcher
shops  located  in  the  immediate  vicinity  of  a  slaughterhouse,  provided  that  such
transport takes not more than two hours one hour.

Meat intended for freezing must be frozen without undue delay, taking into account
where necessary a stabilisation period before freezing.

Exposed meat must be stored in a separate room from packaged meat, unless stored
at different times.

Carcases, half-carcases, half-carcases cut into no more than three wholesale cuts, and
quarters may be transported at temperatures higher than those referred to in point 1,
under  conditions  to  be  set  after  consultation  of  the  European  Food  Safety
Authority Scientific Committee.

Meat  must  not  come  into  contact  with  the  floor.  Containers  must  not  be  placed
directly on the floor.

Packaged meat must not be transported with unpacked meat unless adequate physical
separation is provided. Stomachs may not be transported unless scalded or cleaned,
nor may heads and feet unless they are skinned or scalded and depilated.

CHAPTER X: ADDITIONAL GUARANTEES

In  respect  of  salmonella,  the  following  rules  shall  apply  to  beef  and  veal  meat  and  meat  of
porcine animals intended for Sweden and Finland:

(a)          The consignments must have been subjected to a microbiological test by sampling in

the establishment of origin.

(b)          With regard to meat of bovine and porcine animals, the test provided for in (a) must
not be carried out for consignments intended for an establishment for the purposes of
pasteurisation, sterilisation or treatment having a similar effect.

(c)          The  test  provided  for  in  (a)  must  not  be  carried  out  for  meat  originating  in  an
establishment  which  is  subject  to  an  operational  programme  recognised  by  the
Commission, in accordance with the procedure referred to in Article 6, as equivalent
to that approved for Sweden and Finland.

The  operational  programmes  of  the  Member  States  may  be  amended  and  updated  by  the
Commission in accordance with the procedure referred to in Article 6.

62

SECTION II: MEAT OF POULTRY AND LAGOMORPHS

The requirements of this section apply, by analogy, to meat from lagomorphs.

Ratites  must  be  handled  in  accordance  with  the  requirements  set  out  below  but  with
appropriate  accommodation  adapted  to  the  size  of  the  animals  to  ensure  the  respect  of
hygiene.

1.

2.

3.

CHAPTER I: TRANSPORT OF BIRDS TO THE SLAUGHTERHOUSE

During the collection of birds at the farm and during transport, birds must be handled
carefully  without  causing  unnecessary  distress.  Only  birds  which  do  not  show
symptoms  of  disease  or  other  deficiencies  may  be  transported.  Where  appropriate,
birds  showing  symptoms  of  disease  or  originating  in  flocks  that  are  known  to  be
contaminated with agents of public health importance must be transported under the
control of the competent authority.

Equipment used for collecting live birds must be cleaned and disinfected before re-
use.  Crates  for  delivering  poultry  to  the  slaughterhouse  must  be  made  of
non-corrodible material and be easy to clean and disinfect.

Upon arrival at the slaughterhouse, birds must be rested before slaughter.

CHAPTER II: CONDITIONS FOR SLAUGHTERHOUSES

Slaughterhouses must:

1.

2.

Have a room or covered space for the reception if the animals and for their inspection
before slaughter;

Be constructed in such a way as to avoid the contamination of the meat, ensuring in
particular that:

– 

– 

– 

There  is  a  slaughter  room  for  stunning  and  bleeding  on  the  one  hand,  and
plucking and any scalding on the other, to be carried out in separate places.

There is a room for evisceration and further dressing which is large enough for
evisceration  to  be  carried  out  in  a  place  sufficiently  far  from  the  other  work
stations, or separated from them by a partition, to prevent contamination.

Slaughter  lines  are  designed  to  allow  a  constant  progress  of  the  slaughter
process  and  to  avoid  cross  contamination  between  different  parts  of  the
slaughter line as well as contact between carcasses and walls, equipment etc.

– 

There is an appropriate area, sufficiently protected, for dispatching meat.

3.            Have  refrigeration  facilities  of  sufficient  capacity  in  relation  to  the  volume  of

production.

3.

Have lockable premises for the refrigerated storage of detained meat and products
unfit for consumption.

63

4.

5.

6.

7.

Have facilities for disinfecting tools with hot water supplied at not less than 82°, or
an alternative system having an equivalent effect.

Have  equipment  for  washing  hands  used  by  the  staff  engaged  in  handling  exposed
meat provided with taps that are non-hand operable.

Have a separate place with appropriate facilities for the cleaning and disinfection of
means of transport and, where appropriate, transport equipment such as crates. These
places and facilities are not compulsory  if  officially  authorised places and facilities
exist nearby.

Have  suitably  equipped  lockable  facilities  or,  where  necessary,  a  room  for  the
use of the veterinary service only.

CHAPTER III: CONDITIONS FOR CUTTING PLANTS

Cutting plants must:

1.

2.

3.

4.

5.

6.

Be constructed so as to allow constant progress of the operations or ensure separation
between the different batches.

Have  rooms  for  the  separate  storage  of  packed  and  exposed  meat,  unless  stored  at
different times.

Have cutting rooms equipped to ensure that the cold chain is not interrupted during
cutting operations.

The  equipment  for  washing  hands  used  by  staff  handling  exposed  meat  shall  be
provided with taps that are non-hand operable.

Have facilities for disinfecting tools with hot water supplied at not less than 82°, or
an alternative system having an equivalent effect.

If the following operations are undertaken in a cutting plant:

– 

the  evisceration  of  geese  and  ducks  reared  for  the  production  of  "foie  gras",
which have been stunned, bled and plucked on the fattening farm;

– 

the evisceration of "New York dressed" poultry,

separate  rooms  must  be  available  for  that  purpose  unless  these  operations  are
separated  in  time  from  the  cutting  operations  and  proper  cleaning  and  disinfection
procedures are in place.

CHAPTER IV: SLAUGHTER HYGIENE

1.            Crates for delivering live poultry must be cleaned and disinfected each time they are

emptied.

64

1.

2.

3.

4.

5.

6.

7.

8.

Only live animals intended for slaughter may be brought into the slaughter premises
with  the  exemption  of  farmed  ratites  slaughtered  at  the  place  of  production,  “New
York Dressed” poultry slaughtered at the farm, small wild game and geese and ducks
reared for the production of "foie gras" which have been stunned, bled and plucked
on the fattening farm.

Animals  that  have  died  during  transport  or  before  slaughter  shall  not  be  used  for
human consumption.

Where  provided  for  in  Community  legislation,  animals  must  before  slaughter  be
presented  to  the  competent  authority  in  order  to  be  submitted  to  an  ante-mortem
inspection.  Slaughterhouse  operators  shall  follow  the  instructions  of  the  competent
authority  in  order  to  ensure  that  the  ante-mortem  inspection  is  carried  out  under
suitable conditions.

Where  establishments  are  approved  for  the  slaughter  of  different  animal  species  or
for the handling of farmed ratites and small wild game, precautions must be taken to
prevent cross contamination by separation either in time or in space of the operations
carried out on the different species. Separate facilities for the reception and storage
of carcases of farmed ratites slaughtered at the farm and for small wild game must be
available.

Animals  brought  into  the  slaughter  room  must  be  immediately  slaughtered  after
stunning, save in case of slaughter according to religious custom;

Stunning, bleeding, skinning or plucking, dressing and evisceration must be carried
out without delay in such a way that contamination of the meat is avoided. It must in
particular be ensured that measures are taken to prevent the spillage of digestive tract
contents during evisceration

Slaughtered  animals  must  be  submitted  to  a  post-mortem  inspection  under  the
supervision  of  the  competent  authority.  Slaughterhouse  operators  shall  follow  the
instructions  of  the  competent  authority  in  order  to  ensure  that  the  post-mortem
inspection  is  carried  out  under  suitable  conditions  ensuring  in  particular  that
slaughtered poultry can be inspected properly.

Viscera  or  parts  of  viscera  which  have  not  been  removed  from  the  carcase  before
post-mortem  inspection  must,  except  for  the  kidneys,  be  removed  entirely,  if
possible,  and  as  quick  as  possible  after  inspection  has  been  completed,  unless  the
competent authority permits some other arrangement.

After inspection and evisceration, slaughtered birds must be cleaned and chilled to a
temperature of not more than 4°C as soon as possible, unless the  meat  is cut while
warm. The cut meat must immediately be chilled to 4°C.

"New York dressed poultry" obtained at the farm of production may be kept for up to
15 days at a temperature which must not exceed 4°C; they must, at the latest at the
end  of  this  period,  be  eviscerated  in  a  slaughterhouse  or  in  a  cutting  plant.  Such
poultry  must  be  accompanied  by  a  certificate  signed  by  the  competent  authority
stating  that  the  uneviscerated  carcases  are  of  birds  which  were  examined  before
slaughter  on  the  farm  of  origin  and  were  found  to  be  healthy  at  the  time  of
examination.

65

9.

When poultry carcases are subjected to an immersion chilling process, account must
be taken of the following:

(a)

Every  precaution  must  be  taken  to  avoid  cross-contamination  of  carcases
taking  into  account  parameters  such  as  carcase  weight,  water  temperature,
volume and direction of water flow and chilling time.

(b) Equipment  must  be  entirely  emptied,  cleaned  and  disinfected  whenever  this  is

necessary but at least once a day.

(c) Calibrated control equipment must continuously record the following:

– 

– 

– 

– 

the water consumption during spray-washing before immersion,

the temperature of the water of the tank or tanks at the points of entry and
exit of the carcases,

the water consumption during immersion,

the total weight of the immersed carcases.

10.

Sick  or  suspect  birds  or  birds  slaughtered  in  application  of  disease  eradication  or
control  programmes  must  not  be  slaughtered  in  the  establishment  except  when
permitted  by  the  competent  authority.  In  that  event,  slaughter  must  be  performed
under  official  supervision  and  steps  taken  to  prevent  contamination;  the  premises
must be cleaned and disinfected before being used again.

CHAPTER V: HYGIENE DURING CUTTING AND BONING

The work on meat must be organised in such a way as to prevent contamination, the growth
of pathogenic micro-organisms or the formation of toxins or other pathogenic substances, and
in particular:

1.

2.

3.

4.

Meat  intended  for  cutting  must  be  brought  into  the  work  rooms  progressively  as
needed.

During  cutting,  boning, slicing,  dicing, wrapping  and packaging, the cooling of  the
meat must not be interrupted.

Where  meat is  boned and  cut prior to reaching 4°C, such meat must be transferred
directly from the slaughter premises to the cutting room in a single operation, or after
a  waiting  period  in  the  cold  store.  Cutting  must  be  carried  out  immediately  after
transfer.

As soon as it is cut, and where appropriate wrapped and packaged, the meat must be
chilled to 4°C.

Where the premises are approved  for the  cutting of meat of different species or  for
handling  “New  York  Dressed”  poultry  and  small  wild  game,  precautions  must  be
taken to avoid cross-contamination, where necessary by separation of the operations
of the different species in either space or time.

66

CHAPTER VI: SLAUGHTER AT THE FARM

1.            Subject  to  the  conditions  below,  the  competent  authority  may  permit  the
poultry referred to in Chapter IV, point 1, to be slaughtered at the farm:

(a)     The  farm  must  undergo  regular  veterinary  inspection  and  not  be  placed

under any animal or public health restriction.

(b)     The  competent  authority  must  be  informed  in  advance  of  the  date  on

which birds are to be slaughtered.

(c)      The  farm  must  have  a  collection  point  where  the  group  of  birds  to  be

slaughtered can undergo an ante-mortem inspection.

(d)     The  farm  must  have  the  premises  required  to  enable  birds  to  be

slaughtered hygienically and handled further.

(e)      Animal welfare requirements must be observed.

(f)      Birds must be accompanied by  relevant  information  from  the  records  or
documentation referred to in Annex I, Chapter II,  point  2, of  Regulation
(EC) No .../... [on the hygiene of foodstuffs], and by a certificate signed by
the competent authority stating that they were examined before slaughter
on the farm of origin and found to be healthy at the time of examination.

2.            Where  poultry  is  reared  for  the  production  of  "foie  gras",  the  uneviscerated
carcases must be transported immediately, while maintaining a continuous cold
chain,  to  a  slaughterhouse  or  cutting  plant.  They  must  be  eviscerated  within
24 hours of slaughter under the supervision of the competent authority.

3.            Poultry  carcases  whose  evisceration  has  been  deferred  and  which  have  been
slaughtered  at  the  farm  of  production  may  be  kept  for  up  to  15  days  at  a
temperature  of  not  more  than  4°C.  At  the  end  of  that  period  they  must  be
eviscerated in a slaughterhouse or cutting plant.

CHAPTER VII: SPECIAL CONDITIONS

1.

Member States may adapt the requirements laid down in Chapters II and III  with a
view to accommodate the needs of establishments situated in regions suffering from
special  geographical  constraints  or  affected  by  supply  difficulties,  or  those  serving
the  local  market.  Hygiene  shall  not  be  compromised.  The  Member  States  shall
inform the Commission of the details of such special conditions.

Establishments serving the local market shall mean farms with an annual production
of  under  10.000  birds  supplying  fresh  poultry  meat  coming  from  their  holdings  in
small quantities:

– 

– 

either directly to the final consumer at the holding or at the weekly markets in
the vicinity of their holdings or,

to retailers with a view to direct sale to the final consumer, provided that such
retailers pursue their activities in the same or neighbouring locality as  that of
the producer.

67

2.

Member States may

– 

– 

allow  the  further  handling  in  establishments  approved  for  that  purpose  of
farmed game birds and small farmed game animals which are slaughtered and
bled at the farm;

grant a derogation from the slaughter and evisceration provisions in the case of
the production of partially eviscerated or non-eviscerated farmed game birds.

3.

Slaughter, bleeding and plucking of poultry reared and slaughtered for the production
of "foie gras" may be carried out at the  farm,  provided  these operations are  carried
out  in  a  separate  room  fully  complying  with  hygiene  rules.  The  uneviscerated
carcases must be transported immediately, under respect of the cold chain principles,
to a slaughterhouse or cutting plant with a special room where the carcases must be
eviscerated within 24 hours under the supervision of the competent authority. During
transport, such poultry carcases must be accompanied by a certificate signed by the
official veterinarian giving information about the health status of the flock of origin
and the hygiene at the farm of production.

4.

Where  the  competent  authority  authorises  the  slaughter  of  animals  at  the  farm  in
accordance with point 3, the following conditions shall apply:

– 

– 

– 

– 

– 

the  farm  must  undergo  regular  veterinary  inspection  and  not  be  placed  under
any animal- or public-health restriction;

the competent authority must be informed in advance of the date of slaughter
of birds;

the  holding  must  have  facilities  for  concentrating  the  birds  to  allow  an
ante-mortem inspection of the group to be made;

the holding must have premises suitable for the hygienic slaughter and further
handling of the birds;

animal welfare requirements must be complied with.

CHAPTER VII: APPROVAL AND REGISTRATION OF ESTABMISHMENTS

Slaughterhouses, cutting plants and cold stores must be approved by the competent authority
and  be  given  an  approval  number.  However,  low  capacity  establishments  referred  to  in
Chapter VI distributing their products on the local market only may be registered.

CHAPTER VIII: ADDITIONAL GUARANTEES

In  respect  of  salmonella,  the  following  rules  shall  apply  to  meat  of  domestic  fowl,  turkey,
guinea fowl, ducks and geese intended for Sweden and Finland:

(a)          The consignments must have been subjected to a microbiological test by sampling in

the establishment of origin.

68

(b)          The  test  provided  for  in  (a)  must  not  be  carried  out  for  meat  originating  in  an
establishment  which  is  subject  to  an  operational  programme  recognised  by  the
Commission, in accordance with the procedure referred to in Article 6, as equivalent
to that approved for Sweden and Finland.

The  operational  programmes  of  the  Member  States  may  be  amended  and  updated  by  the
Commission in accordance with the procedure referred to in Article 6.

SECTION III: MEAT OF FARMED GAME

1.

2.

3.

The  provisions  for  meat  of  domestic  ungulates  shall  apply  to  the  production  and
placing  on  the  market  marketing  of  meat  of  farmed  even-toed  game  mammals
(Cervidae and Suidae).

The  provisions  for  poultry  meat  shall  apply  to  the  production  and  placing  on  the
market marketing of meat from ratites. Appropriate facilities must be provided to
accommodate the size of the animals.

Notwithstanding  paragraphs  1  and  2,  the  competent  authority  may  authorise  the
slaughter  of  farmed  game  at  the  place  of  origin  where  it  cannot  be  transported,  in
order to avoid any risk for the handler or to protect the welfare of the animals. This
authorisation may be granted if:

– 

– 

– 

– 

– 

– 

– 

– 

the  animals  cannot  be  transported,  because  a  risk  would  otherwise  be
posed to the handler or the welfare of the animals would be endangered;

the herd undergoes regular veterinary inspection and is not under any animal-
or public-health restriction;

a request is submitted by the owner of the animals;

the competent authority is informed in advance of the date of slaughter of the
animals;

the holding has facilities for concentrating the animals to allow an ante-mortem
inspection of the group to be made;

the holding has premises suitable for the slaughter, sticking and bleeding, and
where ratites are to be plucked, plucking of the animals;

slaughter by sticking and bleeding is preceded by stunning in accordance with
Directive 93/119/EC; slaughter by shooting may be allowed;

slaughtered  and  bled  animals  are  transported  suspended,  under  satisfactory
conditions  of  hygiene,  to  an  approved establishment as soon as  possible  after
slaughter. Where animals slaughtered at the place of rearing cannot be brought
within  one  hour  to  an  approved  establishment,  they  must  be  transported  in  a
container or means of transport in which the ambient temperature is maintained
at between 0°C and 4°C. Evisceration must be carried out as soon as possible
after stunning and bleeding.

69

– 

during  transport  to  the  approved  establishment,  slaughtered  animals  are
accompanied  by  a  certificate  issued  and  signed  by  the  official  veterinarian
attesting to a favourable result of the ante-mortem inspection, correct slaughter
and bleeding and the time of slaughter.

4.            All operations for the slaughter of reindeer destined for intra-Community trade may
be carried out in mobile slaughter units in accordance with the provisions for meat of
domestic  ungulates.  In  accordance  with  the  procedure  referred  to  in  Article  6,  and
after  the  opinion  of  the  Scientific  Committee,  the  conditions  under  which  mobile
slaughterhouses can be used for the slaughter of other species shall be laid down.

SECTION IV: WILD GAME MEAT

This Section does not apply to:

1.            The private use or the preparation of game meat for private use

2.            The direct supplies of small quantities of wild game and game meat to the final
consumer or the local retail trade. These operations shall be subject to national
rules.

trophies or killed wild game transported by travellers, insofar as this involves a small
quantity of small wild game or only one whole item of large wild game  and where
the  circumstances  indicate  that  the  game  is  not  intended  for  commercial  purposes,
and provided that it does not  come from  an area or  region  subject to animal  health
restrictions or restrictions because of the presence of residues.

CHAPTER I: TRAINING OF HUNTERS IN HEALTH AND HYGIENE

1.

Persons  who  place  killed  wild  game  and  game  meat  responsible  for  hunting  wild
game and for placing it on the market for human consumption must have sufficient
knowledge  of  wild  game  hygiene  and  pathology  in  order  to  undertake  an  initial
examination of wild game on the spot.

For that purpose,  Member  States shall ensure that  there are organise training  and
education  schemes  for  hunters,  game  managers,  gamekeepers,  etc.  which  should
must cover at least the following subjects:

– 

– 

– 

– 

normal anatomy, physiology and behaviour of wild game animals;

abnormal  behaviour  and  pathological  changes  in  wild  game  due  to  diseases,
environmental contamination or other factors which  may  affect  human  health
after consumption;

the  hygiene  rules  and  proper 
evisceration, etc. of wild game animals after killing;

techniques  for  handling, 

transportation,

legislation, regulations and administrative provisions on the health and hygiene
conditions governing the placing on the market of wild game.

70

Such  schemes  shall  if  possible  be  set  up  and  run  in  collaboration  with  officially
recognised  hunters’  organisations  in  order  to  guarantee  that  there  is  a  permanent
effort of instructing  and educating hunters about possible public-health risks  due to
meat from wild game.

2.

Hunters, or in a hunting team at least one person shall have the qualifications referred
to above for performing a health check on hunted animals

CHAPTER II: KILLING, EVISCERATION AND TRANSPORT OF WILD GAME TO
AN APPROVED ESTABLISHMENT

1.

2.

After killing, large wild game must be drawn and have their stomachs and intestines
removed; small wild game may be totally or partially eviscerated on the spot or in a
game processing establishment.

Persons  responsible  for  the  placing  on  the  market  of  the  game  must  ensure  that
hunted animals to be sold or placed on the market are submitted to an inspection
by  the  competent  authority  as  soon  as  possible  after  killing  and  in  any  event
before  their  meat  is  placed  on  the  market.  For  that  purpose,  the  following
procedures shall apply:

(a) Carcases and remaining viscera must be moved within a reasonable period of
time 12 hours after killing to a game processing establishment or a collection
centre,  where  they  must  be  chilled  to  the  required  temperature.  In  a  game
collection  centre,  any  intervention  on  the  game  is  forbidden.  If  the  game  is
brought to a collection centre first, it must be transported within 12 hours after
arrival in the collection centre to a game processing establishment or in remote
regions where climatological conditions so permit, within a period to be fixed
by the competent authority. During transport to the game collection centre and
the  game  processing  establishment,  heaping  and  stacking  shall  be  prohibited.
Game collection centres and game processing establishments belonging to
hunting teams in remote regions  may, where  climatological  conditions  so
permit, be exempt from the requirement to have chilling facilities.

(b)     If the game carcase is accompanied by a declaration from the person who
is responsible for the placing on the  market of the game, stating that the
game did not show abnormal characteristics and that there is no suspicion
of environmental contamination, viscera for private  consumption  such as
liver  and  spleen  may  have  been  removed  prior  to  the  transport  to  the
game  processing  establishment;  the  head  may  have  been  removed  as  a
trophy.

(b)     If any abnormal behaviour before killing or pathological changes are detected
during the examination or when environmental contamination is suspected, the
carcase  together  with  the  viscera  must  be  transported  to  the  game  handling
establishment  to  be  submitted  to  a  complete  post-mortem  inspection  and  the
competent  authority  must  ensure  that  the  hunter  informs  the  official
veterinarian  thereof.  The  official  veterinarian  must  submit  the  carcase  to  the
tests  necessary  in  order  to  make  a  diagnosis  about  the  nature  of  the  defect.
After making a diagnosis, the official veterinarian determines if the carcase is
fit for human consumption.

71

It must be ensured that species that may be contaminated by trichinella spiralis
are submitted in an officially recognised laboratory to an examination to detect
the  possible  presence  of 
for  human
consumption.Hunters  or  the  qualified  person  referred  to  in  Chapter  I  point  2
shall  be  held  responsible  for  any  decision  taken  by  them  with  regard  to  the
examination of wild game for the possible presence of a health risk.

that  parasite  before 

release 

Where a hunter is not qualified or when in a hunting team there is no qualified
person as referred to in Chapter I point 2, the hunted animal together with its
viscera shall be presented for inspection by the competent authority in a game
handling establishment.

(c)      If  any  abnormal  behaviour  before  killing  or  pathological  changes  are
detected during the examination or when environmental contamination is
suspected, the carcase together with the viscera (apart from the stomachs
and  intestines),  which  must  remain  identifiable  as  belonging  to  a  given
carcase,  must  be  transported  to  the  game  processing  establishment  to  be
submitted  to  a  complete  post-mortem  inspection  and  the  competent
authority  must  ensure  that  the  hunter  informs  the  official  veterinarian
thereof. The official veterinarian must submit the carcase to the necessary
tests  in  order  to  make  a  diagnosis  about  the  nature  of  the  defect.  After
making a diagnosis, the official veterinarian shall determine if the carcase
is fit for human consumption.

3.            It must be ensured that species that may be contaminated by trichinella spiralis
are submitted in an officially recognised laboratory to an examination to detect
the possible presence of that parasite before release for human consumption.

4.

5.

Wild game carcases must be chilled to a temperature of not more than 7°C for large
game and not more than 4°C for small game and offal.

Where unskinned large game is marketed,

(a)

(b)

their  viscera  must  have  undergone  post  mortem  inspection  in  a  wild  game
processint establishment,

it  must  be  accompanied  by  a  health  certificate  signed  by  the  official
veterinarian  to  certify  that  the  result  of  the  post  mortem  inspection  was
satisfactory,

(c)

it must have been cooled to a temperature not exceeding :

– 

– 

+7°C  and  be  kept  below  this  temperature  for  a  maximum  period  of
7 days from the post mortem inspection, or

+1°C and kept below this temperature for a maximum period of 15 days
from the post mortem inspection,

72

(d)

it must be stored and handled separately from other food.

Meat  from  such  unskinned  wild  game  cannot  bear  the  health  mark  unless,  after
skinning in a game handling establishment, it has undergone post-mortem inspection
and has been declared fit for human consumption.

CHAPTER III: PROCEDURE FOR SMALL WILD GAME

1.            Game  must  be  examined  as  soon  as  possible  after  killing  in  order  to  detect
characteristics  which  may  indicate  that  the  meat  presents  a  health  risk.  The
examination shall be carried out by a qualified person or, where appropriate, a
veterinarian.

2.            Where  no  unusual  characteristics  are  found  in  the  examination  and  no
abnormal  behaviour  was  observed  before  killing  and,  in  addition,  there  is  no
suspicion  of  environmental  contamination,  the  game  may  be  released
immediately  for  direct  private  consumption  or,  subject  to  the  conditions
specified by the competent authority, for retail trade.

3.            If small wild game is transported to a game handling establishment, it must be
chilled to a temperature of not more than 4°C within 24 hours of being killed.
After arrival at the game handling establishment, game carcases must be totally
or partially eviscerated without undue delay.

CHAPTER IV:HYGIENE PROVISIONS IN GAME PROCESSING
ESTABLISHMENTS

This chapter shall not apply to game processing establishments used for the collection or
handling of game meat for private consumption.

1.

2.

3.

Wild game meat must be prepared in an approved game processing establishment.

Evisceration must be carried out without undue delay, upon arrival at the wild game
processing establishment, if it has not been carried out on the spot. The lungs, heart,
kidneys,  mediastinum  and  where  appropriate  the  liver  and  spleen  may  either  be
detached or left attached to the carcase by their natural connections.

During cutting, boning, wrapping and packaging the internal temperature of the wild
game must be kept at a temperature of +7°C or lower in the case of large wild game,
or 4°C or lower in the case of small wild game.

CHAPTER IV: REGISTRATION AND APPROVAL OF ESTABLISHMENTS

1.            Game collection centres shall be registered.

2.            Game handling establishments shall be approved.

73

SECTION V: MINCED MEAT, MEAT PREPARATIONS AND MECHANICALLY
SEPARATED/RECOVERED MEAT

This  Section  does  not  apply  to  the  production  and  placing  on  the  market  marketing  of
minced  meat  intended  for  the  processing  industry;  such  meat  remains  subject  to  the
requirements for fresh meat.

CHAPTER I: ESTABLISHMENTS OF PRODUCTION

1.

Establishments  producing  minced  meat,  meat  preparations,  and  mechanically
separated meat must:

(a)     Be  so  designed  as  to  enable  production  operations 

to  proceed

uninterruptedly and different production batches to be separated.

(b)     Have  separate  rooms  in  which  to  store  packed  and  unwrapped  meat,

unless the products are stored at different times.

(c)      Have rooms equipped to  comply  with  the  temperature  requirements  laid

down in Chapter III.

(d)     Have  hand-washing  facilities  for  staff  handling  unwrapped  meat  so
designed  as  to  prevent  the  spread  of  contamination.  Other  technical
equipment must be so designed as to prevent the spread of contamination.

(e)      Have  facilities  for  disinfecting  tools  using  water  heated  to  not  less  than

82°C or an equivalent alternative system.

1.            Production rooms must be equipped to ensure that the cold  chain is  not interrupted

during the operations.

2.

It must be ensured that the products are microbiologically safe.

3.            Establishments shall be approved by the competent authority.

CHAPTER II: MINCED MEAT REQUIREMENTS FOR RAW MATERIALS

1.

Raw  materials  used  to  produce  minced  meat  must  satisfy  the  following
requirements:

1.            Requirements for the raw materials:

(a) minced  meat  must  have  been  prepared  from  skeletal  muscle  (including  the

adherent fatty tissues);

(b)

frozen or deep-frozen meat used for the preparation of minced meat must have
been  boned  before  freezing  and  have  been  stored  for  a  limited  period  after
boning;

(c)      the  competent  authority  may  authorise  the  boning  of  meat  on  the  spot
immediately before mincing where this operation is carried out in satisfactory
conditions of hygiene and quality;

74

(c)      where it has been prepared from chilled meat, such meat must be used:

– 

– 

within no more than 6 days after slaughter of the animals, or

within no more than 15 days after slaughter of the animals in the case
of boned, vacuum-packed beef and veal;

(d)

in  all  cases,  meat  with  organoleptic  deficiencies  may  not  be  used;  shall  be
excluded from the production of minced meat;

(e) minced meat shall not be obtained from

– 

– 

scrap cuttings and scrap trimmings (other than whole muscle cuttings) or
from mechanically separated meat or meat containing bone fragments
or skin;

meat  from  the  following  parts  of  bovine  animals,  pigs,  sheep  or  goats:
meat of the head  with the  exception of the masseters,  the  non-muscular
part of the  linea  alba,  the  region  of  the  carpus  and  the  tarsus,  and  bone
scrapings. The muscles of the diaphragm - after removal of the serosa -
and  of  the  masseters  may  be  used  only  after  being  examined  for
cysticercosis;

– 

meat containing bone fragments or skin.

Pig meat or horse meat used for minced meat production must have been obtained in
accordance with the requirements regarding trichina examination.

2.

Raw  materials  used  to  produce  mechanically  separated  meat  must  satisfy  the
following requirements:

(a)     They must comply with the requirements for fresh meat.

(b)     The  following  raw  materials  may  not  be  used  to  produce  mechanically

separated meat:

(i)      in poultry: feet, neck-skin, neck-bones, and the head;

(ii)     in  other  animals:  head  bones,  feet,  tails,  the  neck  of  the  femur,  the

tibia, the fibula, the humerus, the radius, and the ulna.

CHAPTER III: HYGIENE DURING AND AFTER PRODUCTION

1.            Meat  must  be  processed  in  such  a  way  as  to  prevent  contamination  as  far  as

possible. Food business operators must accordingly ensure in particular that:

(a)     the  temperature  of  the  meat  used  is  not  more  than  4°C  in  the  case  of
poultry, not more than 3°C in the case of offal, and not more than 7°C in
the case of other meat;

(b)     meat is gradually brought into the work rooms, only as and when needed.

75

2.            The following rules shall apply to the production of minced meat:

(a)

The  mincing  operations  must  be  performed  within  one  hour  from  the  time
when the meat enters the preparation room. A longer time limit may be granted
in individual cases where the addition of salt justifies this on technical grounds,
or  where  hazard  analysis  demonstrates  that  there  is  no  increased  hazard  to
human health.

When the duration of these operations exceeds the time limit referred to above,
the fresh meat may not be used until the internal temperature of the meat has
been reduced to a maximum of 4°C.

(b)

Immediately  after  production,  minced  meat  must  be  hygienically  wrapped
and/or  packaged  and  after  that  be  cooled  to  and  stored  at  a  temperature  not
exceeding 2°C.

(c) Minced meat may be deep-frozen only once.

(d) Minced meat to which not more than 1% of salt has been added shall be subject
to  the  same  requirements.  If  more  than  1%  salt  is  added,  the  product  is
considered to be a meat preparation.

(e)

In order to take account of particular habits of consumption, and on condition
that  the  products  of  animal  origin  do  not  present  a  hazard  to  human  health,
Member  States  may  grant  derogations  from  points  1  to  5.  In  this  case,  the
minced meat must not be given the Community health mark.

(f)      If frozen or deep-frozen meat is used to produce minced meat, it must be
boned  before  freezing,  unless  the  competent  authority  allows  boning
immediately before mincing. The meat may be stored for a limited period
only.

(g)     Minced  meat  made  from  chilled  meat  must  be  produced  within  the

following time-limits:

– 

– 

within not more than six days of the slaughter of the animals or

in the case of vacuum-packed boned beef and veal, within not more
than 15 days of the slaughter of the animals.

(h)     Minced meat must be wrapped or packaged immediately after production

and

(i)      chilled to a core temperature not exceeding 2°C or

(ii)     frozen to a core temperature not exceeding -18°C.

The above temperatures must also be maintained during storage and transport.

76

3.            The  following  requirements  shall  apply  to  the  production  of  mechanically

separated meat:

(a)     Unboned raw materials from an on- site slaughterhouse must be not more
than seven days old. Other raw materials must be not more than five days
old.

(b)     If  mechanical  separation  does  not  take  place  immediately  after  boning,
flesh-bearing bones must be stored and transported at a temperature not
exceeding 2°C or -18°C in the case of frozen products.

(c)      The flesh-bearing bones of frozen carcases may not be refrozen.

(d)     If mechanically separated meat is not used within an hour of production, it

must be chilled immediately to a temperature not exceeding 2°C.

(e)      After  chilling,  mechanically  separated  meat  may  be  processed  within  24
hours  or  must  otherwise  be  frozen  within  12  hours  of  production.  The
freezing layers must reach a core temperature not exceeding -18°C within
six hours.

(f)      Frozen mechanically separated meat must be wrapped or packaged before
storage or transport and may not be stored for longer than three months;
a temperature not exceeding -18°C  must be  maintained  during  transport
and storage.

(g)     Mechanically separated meat may be used only in meat preparations that
are  heated  to  +70°C  for  30  minutes  or  according  to  another  time  and
temperature combination offering the same security.

4.            Minced meat, meat preparations, and mechanically separated meat may not be

refrozen after thawing.

CHAPTER IV: MEAT PREPARATIONS

1.

2.

3.

4.

5.

Meat  preparations obtained from  minced  meat  must  fulfil  the  conditions  laid  down
for minced meat.

The addition of seasonings to whole poultry carcases may be authorised in a specific
room that is clearly separate from the slaughter room.

Where the meat has been frozen or deep-frozen, it must be used within a time period
sufficiently short after slaughter.

Boning  of  meat  on  the  spot  immediately  before  preparation  may  be  authorised,
provided this operation is carried out in satisfactory conditions of hygiene.

Meat preparations may be deep-frozen only once.

77

6.

After their production, wrapping and packaging, meat preparations must be cooled as
quickly as possible to an internal temperature of maximum 4°C.

In  the  deep-frozen  form,  an  internal  temperature  below  -18°C  must  be  reached,  in
accordance with Article1(2) of Directive 89/108/EEC.

CHAPTER IV: MECHANICALLY SEPARATED MEAT (MSM)

MSM must have been obtained under the following conditions:

1.            Raw materials

(a)      The  raw  materials  used  for  the  production  of  MSM  must  comply  with  the

requirements for fresh meat.

(b)     The use of the following is not allowed for the production of MSM:

– 

– 

for poultry: feet, neckskin, neckbones and head;

for other animals: the bones of the head, feet, tails (except bovine tails),
femur,  tibia,  fibula,  humerus,  radius  and  ulna,  the  vertebral  column  of
bovine, ovine and caprine animals.

(c)      Chilled raw material for deboning from an on-site slaughterhouse must not be

older than 7 days.

Chilled  raw  material  for  deboning  from  another  slaughterhouse  must  not  be
older than 5 days.

Flesh bearing bones from frozen carcases may be used.

2.            Conditions for the production of MSM:

(a)      Mechanical  separation  must  take  place  without  undue  delay  after  deboning.

Otherwise, the flesh-bearing bones obtained after boning must

– 

– 

either be chilled at 2°C and stored at a room temperature not exceeding
2°C

or be frozen after boning so as to reach a temperature of -18°C within 24
hours.  Such  bones  must  be  used  within  three  months  after  freezing.
However,  refreezing  of  flesh-bearing  bones  obtained  from  frozen
carcases is not allowed.

(b)     During mechanical separation, the room temperature may not exceed 12°C.

(c)      If not used within one hour after it has been obtained, the MSM must be chilled

immediately to a temperature of not more than 2°C.

After  chilling,  it  can  be  processed  within  24  hours,  or  else  it  must  be  frozen
within 12 hours after production.

78

If  the  MSM  is  frozen,  the  freezing  layers  must  reach  a  core  temperature  of  -
18°C or less within six hours. Frozen MSM shall not be stored for more than
three  months.  Frozen  MSM  must  be  kept  below  -18°C  during  transport  and
storage.

MSM  may  be  transported  from 
to  a  processing
establishment.  The  cold  chain  may  not  be  interrupted  during  transport,  the
product remaining at 2°C or below.

the  separation  unit 

3.

Use of MSM

MSM  may  only  be  used  in  heat-treated  meat  products  in  which  the  temperature
increases  to  +70°C  during  30  minutes  or  any  other  time/temperature  combination
providing the same security.

SECTION VI: MEAT PRODUCTS

CHAPTER I: REQUIREMENTS FOR RAW MATERIALS

The following items may not be used in the preparation of processed meat products:

(a)

(b)

(c)

(d)

(e)

(f)

(g)

genital organs of both female and male animals, except testicles;

urinary organs, except the kidneys and the bladder;

the cartilage of the larynx, the trachea and the extra-lobular bronchi;

eyes and eyelids;

the external auditory meatus;

corneal tissue;

in poultry, the head - except the comb  and the ears, the  wattles  and  caruncles  - the
oesophagus, the crop, the intestines and the genital organs.

CHAPTER II: APPROVAL OF ESTABLISHMENTS

Establishments  for  the  manufacture  of  meat  products  must  be  approved  by  the  competent
authority.  However,  low  capacity  establishments  distributing  their  products  on  the  local
market only may be registered.

SECTION VII: LIVE BIVALVE MOLLUSCS

The  provisions  on  purification  shall  not  apply  to  echinoderms,  tunicates  and  marine
gasteropods.

It shall be ensured that live bivalve molluscs harvested from the wild and destined for direct
human consumption, comply with the standards set out in Chapter IV of this Section.

79

CHAPTER I: SPECIAL HYGIENE CONDITIONS FOR THE PRODUCTION AND
HARVESTING OF LIVE BIVALVE MOLLUSCS

A.

CONDITIONS FOR PRODUCTION AREAS

1.

Live  bivalve  molluscs  shall  only  be  harvested  from  areas  the  location  and
boundaries  of  which  are  fixed  and  classified  by  the  competent  authority  as
follows:

(a) Class A areas: areas from which live bivalve molluscs may be collected
for  direct  human  consumption.  Live  bivalve  molluscs  taken  from  these
areas must meet the requirements of Chapter IV of this Section.

(b) Class B areas: areas from which live bivalve molluscs may be collected,
but only placed on the market for human consumption after treatment in
a purification centre or after relaying.

(c) Class C areas: areas from which live bivalve molluscs may be collected
but placed on the market only after relaying over a long period (at least
two months).

The criteria for the classification of class B or C areas will be laid down
after  obtaining  the  opinion  of  the  European  Food  Safety  Authority.
appropriate Scientific Committee.

After purification or relaying, molluscs from class B or C areas must meet
all of the requirements of Chapter IV of this Section.

However,  live  bivalve  molluscs  from  such  areas  which  have  not  been
submitted  to  purification  or  relaying  may  be  sent  to  a  processing
establishment  where  they  must  be  subjected  to  a  treatment  intended  to
inhibit  the  development  of  pathogenic  micro-organisms.  Such  treatment
must  be  approved  after  obtaining  the  opinion  of  the  European  Food
Safety Authority appropriate Scientific Committee.

2.

3.

Any  production  and  harvesting  of  bivalve  molluscs  in  areas  considered
unsuitable for these activities for health reasons or in areas not classified in one
of  the  categories  referred  to  in  point  3  shall  be  prohibited.  Operators  shall
inform  themselves  with  the  competent  authority  about  the  areas  that  are
suitable for production and harvesting.

The  provisions  laid  down  in  point  1  apply,  with  regard  to  pectinids,  only  to
products  of  farming  aquaculture,  or,  where  data  are  available  permitting  the
classification  of  fishing  grounds, 
if  no
classification  of  fishing  grounds  is  possible,  the  requirements  of  Chapter  IV
apply to pectinids harvested from the wild.

to  wild  pectinids.  However, 

80

B.

CONDITIONS FOR HARVESTING AND TRANSPORTING LIVE BIVALVE
MOLLUSCS  TO  A  DISPATCH  OR  PURIFICATION  CENTRE,  RELAYING
AREA OR PROCESSING PLANT

1.

2.

3.

Harvesting  techniques  and  further  handling  must  not  cause  additional
contamination  and  excessive  damage  to  the  shells  or  tissues  of  live  bivalve
molluscs and must not result in changes significantly affecting their suitability
for treatment by purification, processing or relaying. They must in particular:

– 

– 

– 

be adequately protected from crushing, abrasion or vibration,

not be exposed to extremes of hot or cold temperatures,

not be re-immersed in water which could cause additional contamination.

The means of transport  must  permit  adequate  drainage,  be  equipped  to  ensure
the  best  survival  conditions  possible  and  provide  efficient  protection  against
contamination.

A  registration  document  for  the  identification  of  batches  of  live  bivalve
molluscs  during  transport  from  the  production  area  to  a  dispatch  centre,
purification centre, relaying area or processing establishment is to be issued by
the  competent  authority  at  the  request  of  the  gatherer.  For  each  batch,  the
gatherer  must  complete  legibly  and  indelibly  the  relevant  sections  of  the
registration document. This document must be produced in at least one of the
languages of the country of destination.

The  registration  documents  must  be  sequentially  numbered.  The  competent
authority  must  keep  a  register  containing  the  numbers  of  registration
documents  together  with  the  names  of  the  persons  collecting  live  bivalve
molluscs to whom the documents have been issued. The registration document
for each batch of live bivalve molluscs must be date-stamped upon delivery of
a  batch  to  a  dispatch  centre,  purification  centre,  relaying  area  or  processing
establishment.  It  must  be  kept  by  operators  of  such  centres,  areas  or
establishments  for  at  least  twelve  months,  or,  upon  request  of  the  competent
authority, for a longer period. In addition, the gatherer is also obliged to keep it
for the same period.

However,  if  gathering  is  carried  out  by  the  same  staff  operating  the  dispatch
centre,  purification  centre,  relaying  area  or  processing  establishment  of
destination, the registration document may be replaced by a standing transport
authorisation granted by the competent authority.

4.

If a production or relaying area is closed temporarily, the competent authority
must refrain from issuing registration documents for that area and immediately
suspend the validity of all registration documents already issued.

81

C.

CONDITIONS FOR RELAYING LIVE BIVALVE MOLLUSCS

For relaying live bivalve molluscs, the following conditions must be met:

1.

Food operators may only use Only areas approved by the competent authority
for the relaying of live bivalve molluscs. The boundaries of the sites must be
clearly  identified  by  buoys,  poles  or  other  fixed  means;  there  must  be  a
minimum distance between relaying areas, and also between relaying areas and
production areas, so as to reduce the risk of spread of contamination. ensure
that the quality of the waters is not adversely affected.

2.

Conditions for relaying must ensure optimal conditions for purification. It must
in particular be ensured that:

– 

– 

– 

– 

– 

Techniques  for  handling  live  bivalve  molluscs  intended  for  relaying
permit the resumption of filter-feeding activity after immersion in natural
waters,

Live  bivalve  molluscs  are  not  be  relayed  at  a  density  which  prevents
purification,

Live bivalve molluscs are immersed in sea water at the relaying area for
an appropriate period which is fixed depending on the water temperature.
This  period  must  exceed  the  time  taken  for  levels  of  faecal  bacteria  to
become reduced to the levels permitted under Chapter IV of this Section,

The  minimum  water  temperature  for  effective  relaying  is,  where
necessary, determined and publicised by the competent authority for each
species of live bivalve molluscs and each approved relaying area,

To  prevent  mixing  of  batches,  sites  within  a  relaying  area  are  well
separated.

3.

4.

Permanent  records  of  the  source  of  live  bivalve  molluscs,  relaying  periods,
relaying areas and subsequent destination of the batch after relaying must be kept
by the operators of relaying areas for inspection by the competent authority.

After  harvesting  from  a  relaying  area,  batches  must  be  accompanied  by  a
registration  document  during  transport  from  the  relaying  area  to  the  approved
dispatch centre, purification centre or processing establishment except where the
same  staff  operates  both  the  relaying  area  and  the  dispatch  centre,  purification
centre or processing establishment. This document must be produced in at least
one of the languages of the country of destination.

82

CHAPTER II: DISPATCH AND PURIFICATION CENTRES

A.

PREMISES

1.

2.

The location of premises must not be subject to flooding by ordinary high tides
or run-off from surrounding areas.

All purification or dispatch centres must be equipped with When seawater
is used, facilities for the supply of clean sea water must be available.

B.

SPECIAL CONDITIONS FOR PURIFICATION CENTRES

In addition to the conditions laid down under A, purification centres must meet the
following conditions:

– 

– 

– 

– 

the internal surfaces of the purification tanks and any water storage containers
must  be  smooth, durable and impermeable, easy to  clean  by  scrubbing  or  the
use of pressurised water;

the purification tanks must be constructed so as to allow complete draining of
water;

the purification tanks must be supplied with a sufficient flow of clean sea water
and sufficient water outlet capacity for the volume of products to be purified;

if the purification centre does not have a directly pumped clean water supply, it
must have equipment making it possible to purify the sea water.

CHAPTER III: HYGIENE CONDITIONS IN DISPATCH AND PURIFICATION
CENTRES

A.

HYGIENE CONDITIONS TO BE MET IN PURIFICATION CENTRES

1.

2.

3.

4.

Before purification commences, live bivalve molluscs must be washed free of
mud  and  accumulated  debris  using  pressurised  clean  sea  water  or  potable
water.

The purification tanks must be supplied with  a sufficient  flow of sea water per
hour and per tonne of live bivalve molluscs treated; the distance between the sea
water  intake  point  and  the  waste  water  outlets  must  be  sufficient  to  avoid
contamination.

Operation of the purification system must allow live bivalve molluscs to rapidly
resume  filter-feeding  activity,  eliminate  sewage  contamination,  not  become  re-
contaminated and be able to remain alive in a suitable condition after purification
for wrapping, storage and transport before being placed on the market.

The quantity of live bivalve molluscs to be purified must not exceed the capacity
of  the  purification  centre;  the  live  bivalve  molluscs  must  be  continuously
purified  for  a  period  sufficient  to  allow  the  microbiological  standards  of
Chapter IV of this Section to be met.

83

5.

6.

7.

8.

9.

Should a purification tank contain several species of bivalve molluscs, the length
of the treatment must be based on the time required by the species needing the
longest period of purification.

Containers used to hold live bivalve molluscs in purification systems must have
a construction which allows sea water to flow through; the depth of layers of live
bivalve molluscs must not impede the opening of shells during purification.

After  completion  of  purification,  the  shells  of  live  bivalve  molluscs  must  be
washed thoroughly by hosing with potable water or clean sea water.

No crustaceans, fish or other marine species may be kept in a purification tank in
which live bivalve molluscs are undergoing purification.

Purification  centres  must  accept  only  batches  of  live  bivalve  molluscs  which
are accompanied by a registration document.

10.

Purification  centres  sending  batches  of  live  bivalve  molluscs  to  dispatch
centres must provide a registration document.

11. Every package containing purified live bivalve molluscs sent to a dispatch centre
must be provided with a label certifying that all molluscs have been purified.

B.

HYGIENE CONDITIONS TO BE MET IN DISPATCH CENTRES

1.

2.

3.

Handling of molluscs such as packing or calibration procedures must not cause
contamination of the product or affect the viability of the molluscs.

Any  washing  or  cleaning  of  live  bivalve  molluscs  must  be  carried  out  using
pressurised  clean  sea  water  or  potable  water;  cleaning  water  may  not  be
recycled.

Dispatch  centres  must  accept  only  batches  of  live  bivalve  molluscs  which  are
accompanied  by  the  registration  document  referred  to  under  point I.B(4)  and
come from an approved production area (class A), relaying area or purification
centre.

4. Molluscs must be kept away from places to which domestic animals have access.

5.

Dispatch centres situated aboard vessels are subject to the conditions laid down
in points 1, 2 and 4. The molluscs must come from an approved production area
(class A). The conditions laid down in Chapter II(A) apply mutatis mutandis to
such dispatch centres, although special conditions may be laid down.

84

CHAPTER IV: HEALTH STANDARDS FOR LIVE BIVALVE MOLLUSCS

Live  bivalve  molluscs  placed  on  the  market  for  human  consumption  must  comply  with  the
following requirements:

1.

2.

3.

4.

5.

They must have organoleptic characteristics associated with freshness and viability,
including  shells  free  of  dirt,  an  adequate  response  to  percussion,  and,  except  for
Pectinidae, normal amounts of intravalvar liquid.

They  must  respect  microbiological  criteria  or  be  produced  in  conformity  with
microbiological guidelines to be established.

They  must  not  contain  toxic  or  objectionable  compounds  occurring  naturally  or
added to the environment in such quantities that the calculated dietary intake exceeds
the permissible daily intake (PDI).

The upper limits for radionuclide levels must not exceed the limits for foodstuffs as
laid down by the Community.

Limits for marine biotoxines:

(a)

The  total  Paralytic  Shellfish  Poison  (PSP)  content  in  the  edible  parts  of  the
molluscs  (the  whole  body  or  any  part  edible  separately)  must  not  exceed
80 micrograms  per  100  g  of  mollusc  flesh  in  accordance  with  a  method
recognised by the Commission.

(b) The total Amnesic Shellfish Poison (ASP) content in edible parts of molluscs
(the  entire  body  or  any  edible  part  edible  separately)  must  not  exceed
20 micrograms of domoic acid per gram using the HPLC method.

(c)

The customary biological testing methods must not give a positive result to the
presence of Diarrheic Shellfish Poison (DSP) in the edible parts of the molluscs
(the whole body or any part edible separately).

The  following  shall  be  laid  down,  in  cooperation  with  the  relevant  Community  Reference
Laboratory, and after obtaining the opinion of the European Food Safety Authority:

– 

– 

– 

– 

limit values and analysis methods for other marine biotoxins, where the need occurs,

virus testing procedures and virological standards,

sampling plans as well as the methods and analytical tolerances to be applied in order
to check compliance with the health standards. Pending decisions thereon, methods
for checking compliance with the health standards must be scientifically recognised.

other  health  standards  or  checks  are  to  be  introduced  where  there  is  scientific
evidence indicating that this should be done in order to protect public health.

85

1.

2.

CHAPTER V: WRAPPING OF LIVE BIVALVE MOLLUSCS

Oysters must be wrapped with the concave shell downwards.

All  wrappings  of  live  molluscs,  including  vacuum  wrapping  in  sea  water,  must  be
closed and remain closed from the dispatch centre until delivery to the consumer or
retailer.  However,  wrappings  may  be  opened  at  a  dispatch  centre  to  re-wrap  the
molluscs  or  at  a  purification  centre  to  purify  them.  and  the  molluscs  be  re-
wrapped in an approved dispatch or purification centre.

CHAPTER VI: APPROVAL OF ESTABLISHMENTS

Dispatch and purification centres shall be approved by the competent authority.

CHAPTER VII: HEALTH MARKING AND LABELING

1.

2.

3.

The health marking must be waterproof.

In  addition  to  the  health  marking  requirements,  the  following  information  must  be
present on the label:

– 

– 

the species of bivalve mollusc (common name and scientific name),

the date of wrapping, comprising at least the day and the month.

By way of derogation from European Parliament and Council Directive 2000/13/EC
of 20 March 2000 on the approximation of the laws of the Member States relating to
the labelling, presentation and advertising of foodstuffs42, the date of durability may
be replaced by the entry 'these animals must be alive when sold'.

The label attached to the wrapping of live bivalve molluscs which are not wrapped in
individual consumer-size parcels must be kept for at least 60 days by the retailer after
splitting up the contents.

CHAPTER VIII: STORAGE AND TRANSPORT OF LIVE BIVALVE MOLLUSCS

1.

2.

In storage rooms, live bivalve molluscs must be kept at a temperature which does not
adversely affect their safety and viability.

Notwithstanding the provisions Chapter V, point 2, of this section, re-immersion
in or spraying with water of live bivalve molluscs must not take place after they have
been wrapped and have left the dispatch centre, except in the case of retail sale at the
dispatch centre or under particular conditions to be laid down.

42

OJ L 109, 6.5.2000, p.29.

86

                                                
SECTION VIII: FISHERY PRODUCTS

CHAPTER I: CONDITIONS FOR FISHERIES VESSELS

Fishery  products  caught  in  their  natural  environment  must  have  been  caught  and,  where
appropriate, handled for bleeding, heading, gutting and the removal of fins, chilled, frozen or
processed and/or wrapped/packaged on board vessels in accordance with the rules laid down
in this Chapter.

I.

CONDITIONS FOR THE EQUIPMENT OF FISHERIES VESSELS

A. CONDITIONS APPLICABLE TO ALL VESSELS

1.

2.

3.

Fisheries  vessels  must  be  designed  and  constructed  so  as  not  to  cause
contamination of the products with bilge-water, sewage, smoke, fuel, oil,
grease or other objectionable substances.

Surfaces  with  which  the  fish  comes  into  contact  must  be  of  suitable
corrosion-resistant  material  which  is  smooth  and  easy  to  clean.  Surface
coatings must be durable and non-toxic.

Equipment  and  material  used  for  working  on  fish  must  be  made  of
corrosion-resistant material which is easy to clean.

B.

FACTORY VESSELS

1.

Factory vessels must have at least:

(a)

a  receiving  area  reserved  for  taking  fishery  products  on  board,
designed to allow each successive catch to be separated. This area
must  be  easy  to  clean  and  designed  so  as  to  protect  the  products
the  elements  and  from  any  source  of
from 
contamination;

the  sun  or 

(b)

a  hygienic  system  for  conveying  fishery  products  from  the
receiving area to the work area;

(c) work areas that are  large  enough  for  the  hygienic  preparation  and
processing  of  fishery  products,  easy  to  clean  and  designed  and
arranged  in  such  a  way  as  to  prevent  any  contamination  of  the
products;

(d)

storage  areas  for  the  finished  products  that  are  large  enough  and
designed so that they are easy to  clean; if a  waste-processing unit
operates  on  board,  a  separate  hold  must  be  designated  for  the
storage of such waste;

(e)

a  place  for  storing  packaging  materials  that  is  separate  from  the
product preparation and processing areas;

87

(f)

(g)

special  equipment  for  pumping  waste  or  fishery  products  that  are
unfit  for  human  consumption  directly  into  the  sea  or,  where
circumstances  so  require,  into  a  watertight  tank  reserved  for  that
purpose; if waste is stored and processed on board with a view to
its sanitation, separate areas must be allocated for that purpose;

equipment providing a supply of potable water within the meaning
of Council Directive 98/83/EC of 3 November 1998 on the quality
of  water  intended  for  human  consumption43,  or  pressurised  clean
sea water or clean river or lake water. The sea water intake must be
situated  in  a  position  where  it  is  not  possible  for  the  water  being
taken  in  to  be  affected  by  discharges  into  the  sea  of  waste  water,
waste and engine coolant;

(h)

appliances for cleaning and disinfecting hands with taps that must
not be manually operated unless a procedure of equal guarantee can
be demonstrated, and hygienic means of drying hands.

2.

Factory vessels which freeze fishery products must have:

(a)

(b)

freezing  equipment  with  sufficient  capacity 
the
temperature rapidly so as to achieve a core temperature of -18°C or
lower;

lower 

to 

refrigeration equipment with sufficient capacity to maintain fishery
products in the storage holds at -18°C or lower. Storage holds must
be equipped with a temperature-recording device in a place where
it can be easily read. The temperature sensor of the reader must be
situated in the area where the temperature in the hold is the highest.

Whole frozen fish in brine intended for the manufacture of  canned food
may be kept at a temperature of -9°C or lower.

C.

FREEZER VESSELS AND VESSELS DESIGNED AND EQUIPPED TO
PRESERVE  FISHERY  PRODUCTS  FOR  MORE  THAN  TWENTY-
FOUR HOURS

1.

Such  vessels  must  be  equipped  with  holds,  tanks  or  containers  for  the
storage of refrigerated or frozen fishery products at the temperatures laid
down  in  this  Section.  The  holds  must  be  separated  from  the  engine
compartments  and  from  the  crew  quarters  by  partitions  which  are
sufficient  to  prevent  any  contamination  of  the  stored  fishery  products.
The  freezing  and  refrigeration  equipment  is  subject  to  the  same
conditions as laid down for factory vessels under B(3).

2.

The  holds  shall  be  designed  to  ensure  that  melt  water  cannot  remain  in
contact with fishery products.

43

OJ L 330, 5.12.1998, p. 32.

88

                                                
3.

4.

their
Containers  used  for 
preservation  under  satisfactory  conditions  of  hygiene  and,  in  particular,
be clean and allow the drainage of melt water.

the  storage  of  products  must  ensure 

In vessels equipped for chilling fishery products in cooled sea water, tanks
must incorporate devices for achieving a uniform temperature throughout
the tanks; a chilling rate must be achieved which ensures that the mix of
fish and sea water reaches 3°C at the most 6 hours after loading and 0°C
at the most after 16 hours.

II.

HYGIENE ON BOARD FISHING VESSELS

The following hygiene conditions apply to fishery products on board fishing vessels:

1. When in use, the parts of fishing vessels or containers set aside for the storage
of  fishery  products  must  be  clean  and,  in  particular,  must  not  be  capable  of
being contaminated by fuel or bilge water.

2.

3.

4.

As  soon  as  possible  after  they  are  taken  on  board,  fishery  products  must  be
protected from contamination and from the effects of the sun or any other source
of  heat.  When  they  are  washed,  the  water  used  must  be  either  fresh  water
complying  with  the  parameters  set  out  in  Directive  98/83/EC,  or  where
appropriate, clean sea water or clean river or lake water.

Fishery products must be handled and stored so as to prevent bruising. The use
of spiked instruments is allowed for moving large fish or fish which might injure
the handler, provided the flesh of these products is not damaged.

Fishery products other than those kept alive must undergo cold treatment as soon
as  possible  after  loading.  However,  when  cooling  is  not  possible,  fishery
products must be landed as soon as possible.

5. When ice is used  for  chilling  products, it must be made  from  potable  water or
clean sea water or clean river or lake water. Before use, it must be stored under
conditions which prevent its contamination.

6. Where fish are headed and/or gutted on board, such operations must be carried
out  hygienically  as  soon  as  possible  after  capture,  and  the  products  must  be
washed immediately and thoroughly with potable water, clean sea water or clean
river or lake water.  In  that  event, the  viscera  and parts  which may  constitute  a
danger to public health must be removed as soon as possible and kept apart from
products intended for human consumption. Livers and roes intended for human
consumption must be preserved under ice, at the temperature of melting ice or be
frozen.

7. Where  freezing  in  brine  of  whole  fish  intended  for  canning  is  practised,  a
temperature of -9°C must be achieved for the product. The brine must not be a
source of contamination for the fish.

8.

The cooking of crustaceans and molluscs on board must be carried out under the
conditions laid down in Chapter III point V.

89

CHAPTER II: CONDITIONS OF HYGIENE DURING AND AFTER LANDING

1.

2.

Unloading and landing equipment must be constructed of material which is easy to
clean and disinfect and must be maintained in a good state of repair and cleanliness.

During unloading and landing, contamination of fishery products must be avoided. It
must in particular be ensured that:

– 

– 

– 

unloading and landing operations proceed rapidly,

fishery  products  are  placed  without  delay  in  a  protected  environment  at  the
temperature required,

equipment and practices that cause unnecessary damage to the edible parts of
the fishery products are not authorised.

3.

Auction and wholesale markets or parts thereof where fishery products are displayed
for sale must:

(a)

at  the  time  of  display  or  storage  of  fishery  products,  not  be  used  for  other
purposes.  Vehicles  emitting  exhaust  fumes  likely  to  impair  the  quality  of  the
fishery products must not be admitted to markets. Persons having access to the
premises are not allowed to introduce animals therein.

(b) when seawater is used, have facilities for the supply of clean sea water.

4.

After landing or, where appropriate, after first sale, fishery products must be conveyed
without delay to their place of destination, or else stored in  cold rooms  before being
displayed  for  sale  or  after  being  sold  and  pending  transport  to  their  place  of
destination.  In  such  cases,  fishery  products  must  be  stored  at  the  temperature
approaching that of melting ice.

CHAPTER III: SPECIAL CONDITIONS

I.

CONDITIONS FOR FRESH PRODUCTS

1. Where chilled, unpacked products are not distributed, dispatched, prepared or
processed  immediately  after  reaching  an  establishment,  they  must  be  stored
under ice in a  cold  room. Re-icing  must  be carried out  as  often  as necessary;
the ice used, with  or  without  salt,  must  be  made  from  potable  water  or  clean
sea, river or lake water  and be stored hygienically in receptacles provided for
the  purpose.  Wrapped  fresh  products  must  be  chilled  with  ice  or  with  a
mechanical refrigeration appliance giving similar temperature conditions.

2.

Operations  such  as  heading  and  gutting  must  be  carried  out  hygienically;  the
products  must  be  washed  thoroughly  with  potable  water  or  clean  sea,  river  or
lake water immediately after these operations.

90

3.

Operations  such  as  filleting  and  cutting  must  be  carried  out  so  as  to  avoid
contamination or spoilage of fillets and slices, and in a place other than used for
heading  and  gutting.  Fillets  and  slices  must  not  remain  on  the  work  tables
beyond  the  time  necessary  for  their  preparation  and  must  be  protected  from
contamination by suitable wrapping. Fillets and slices must be chilled as quickly
as possible after their preparation.

4.

Containers  used  for  the  dispatch  or  storage  of  fresh  fishery  products  must
provide adequate drainage of melt water.

II.

CONDITIONS FOR FROZEN PRODUCTS

Establishments  where  fishery  products  are  frozen  must  have  equipment  which
satisfies the same requirements for freezing and storage as set out for factory vessels
which freeze fishery products.

III.

CONDITIONS FOR MECHANICALLY SEPARATED FISH FLESH

1. Mechanical separation of gutted fish must take place without undue delay after
filleting, using raw materials free from guts. If whole fish are used, they must be
gutted and washed beforehand.

2.

After  production,  mechanically  recovered  flesh  must  be  frozen  as  quickly  as
possible  or  incorporated  in  a  product  intended  for  freezing  or  a  stabilising
treatment.

IV.

CONDITIONS CONCERNING ENDO-PARASITES HARMFUL TO HUMAN
HEALTH

1.

The following fishery products must be frozen at a temperature of not more than
-20°C in all parts of the product for not less than 24 hours; this treatment must be
applied to the raw product or the finished product.

(a)

Fish to be consumed raw or almost raw, e.g. raw herring (maatjes).

(b) The following species  if they  are  to  undergo  a  cold  smoking process in

which the internal temperature of the fish is less than 60°C:

– 

– 

– 

– 

herring,

mackerel,

sprat,

(wild) Atlantic and Pacific salmon;

(c) Marinated  and/or  salted  herring  where  this  process  is  insufficient  to

destroy nematode larvae.

91

2. Where epidemiological data are available indicating that the fishing grounds of
origin do not present a health hazard with regard to the presence of parasites, a
derogation  from  the  above  treatment  may  be  granted  by  the  Member  States.
Member States implementing this derogation must inform the Commission and
the other Member States thereof.

3. When  placed  on  the  market,  the  fishery  products  referred  to  above  must  be
accompanied by a document from the manufacturer stating the type of process
they have undergone.

4.

Before being placed on the market marketing, fish and fish products must be
given a visual examination for the purpose of detecting endo-parasites that are
visible. Fish  or parts  of  fish which  are obviously contaminated with  parasites
must be removed and not be used for human consumption.

V.

COOKED CRUSTACEANS AND MOLLUSCS

Crustaceans and molluscs must be cooked as follows:

(a)

(b)

(c)

any  cooking  must  be  followed  by  rapid  cooling.  Water  used  for  this  purpose
must be potable water within the meaning of Directive 98/83/EC or clean sea,
river  or  lake  water.  If  no  other  method  of  preservation  is  used,  cooling  must
continue until a temperature approaching that of melting ice is reached;

shelling or shucking must be carried out hygienically, avoiding contamination
of  the  product.  Where  such  operations  are  done  by  hand,  workers  must  pay
particular  attention  to  washing  their  hands  and  all  working  surfaces  must  be
cleaned  thoroughly.  If  machines  are  used,  they  must  be  cleaned  at  frequent
intervals and disinfected according to a schedule drawn up under the HACCP
procedures;

after  shelling  or  shucking,  cooked  products  must  be  frozen  immediately,  or
kept chilled at a temperature which will preclude the growth of pathogens and
be  stored  in  appropriate  rooms  allowing  maintenance  of  the  temperatures
required.

CHAPTER IV: HEALTH STANDARDS FOR FISHERY PRODUCTS

1.

Organoleptic properties of fishery products

Organoleptic  examinations  of  fishery  products  must  be  carried  out  so  as  to  ensure
their  hygienic  quality.  Where  necessary,  freshness  criteria  are  to  be  issued  after
obtaining  the  opinion  of  the  European  Food  Safety  Authority  Scientific
Committee.

2.

Histamine

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

– 

the mean value must not exceed 100 ppm,

92

– 

– 

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

no sample may have a value exceeding 200 ppm.

These  limits  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, such as high performance liquid chromatography (HPLC).

3.

Total Volatile Nitrogen (TVB-N)

Unprocessed fishery products shall be regarded as unfit for human consumption where,
organoleptic  assessment  having  raised  doubts  as  to  their  freshness,  chemical  tests
reveal that the limits to be fixed with regard to TVB-N have been exceeded.

4.

Toxins harmful to human health

The placing on the market of the following products is prohibited:

– 

– 

poisonous 
Diodontidae, Canthigasteridae,

fish  of 

the 

following 

families:  Tetraodontidae,  Molidae,

fishery products containing biotoxins such as ciguatoxin or muscle-paralysing
toxins

CHAPTER V: WRAPPING AND PACKAGING OF FISHERY PRODUCTS

Containers  in  which  fresh  fishery  products  are  kept  under  ice  must  be  water-resistant  and
provide adequate drainage for melt water.

Frozen  blocks  prepared  on  board  fisheries  vessels  must  be  adequately  wrapped  before
landing.

1.

2.

1.

CHAPTER VI: STORAGE OF FISHERY PRODUCTS

Fresh or thawed fishery products, and cooked and chilled products from crustaceans
and molluscs must be maintained at the temperature of melting ice.

Frozen fishery products must be kept at a temperature of -18°C or below in all parts of
the  product;  however,  whole  frozen  fish  in  brine  intended  for  the  manufacture  of
canned food may be kept at a temperature of -9°C or less.

CHAPTER VII: TRANSPORT OF FISHERY PRODUCTS

During transport, fishery products must be maintained at the required temperature. In
particular:

(a)

fresh  or  thawed  fishery  products,  and  cooked  and  chilled  products  from
crustaceans  and  molluscs,  must  be  maintained  at  the  temperature  of  melting
ice;

93

(b)

frozen fishery products, with the exception of frozen fish in brine intended for
the  manufacture  of  canned  food,  must  be  maintained  during  transport  at  an
even temperature of  -18°C  or  below  in  all parts of the product, with possibly
short upward fluctuations of not more than 3°C.

When  frozen  fishery  products  are  transported  from  a  cold  store  to  an  approved
establishment  to  be  thawed  on  arrival  for  the  purposes  of  preparation  and/or
processing,  and  where  the  journey  is  short,  the  competent  authority  may  grant  a
derogation from the conditions laid down in point 1 (b).

If  ice  is  used  to  chill  the  products,  adequate  drainage  must  be  provided  in  order  to
ensure that melting water does not remain in contact with the products.

Fishery products to be placed on the market live must be transported in such a way that
the hygiene of the product is preserved.

2.

3.

4.

CHAPTER VIII: APPROVAL AND REGISTRATION OF ESTABLISHMENTS

Factory  vessels,  freezer  vessels  and  establishments  on  land  shall  be  approved  by  the
competent authority. However, establishments on land placing marketing their products on
the local market only may be registered.

Wholesale  markets  where  fishery  products  are  not  worked  upon  but  are  only  displayed  for
sale and auction halls shall be registered.

SECTION IX: RAW MILK AND PROCESSED MILK PRODUCTS

CHAPTER I: RAW MILK-PRIMARY PRODUCTION

I.

HEALTH CONDITIONS FOR MILK PRODUCTION

1.

Raw milk must come:

(a)

from cows or buffaloes:

(i)

belonging  to  a  herd  which,  under  points  I  and  II  of  Annex  A  of
Directive 64/432/EEC, is officially free of tuberculosis and free or
officially free of brucellosis;

(ii) which  do  not  show  any  symptoms  of 
communicable to humans through milk;

infectious  diseases

(iii)

in a good general state of health and presenting no obvious sign of
disease that might result in contamination of the milk;

(iv) which are not suffering from any infection of the genital tract with
discharge,  enteritis  with  diarrhoea  and  fever,  or  a  recognisable
inflammation of the udder;

(v) which do not have any udder wound likely to affect the milk;

94

(vi) which have not been treated with substances dangerous or likely to
be dangerous to human health that are transmissible to milk, unless
the  milking  has  complied  with  an  official  withdrawal  period  laid
down in Community rules or, if absent, in national rules;

(b)

from sheep or goats:

(i)

belonging  to  a  holding  officially  free  or  free  of  brucellosis
(Brucella melitensis) within the meaning of Article 2(4) and (5) of
Directive 91/68/EEC,

(ii)

satisfying the requirements of point (a), except point (a)(i).

(c)

from females of other species:

(i)

belonging, for species susceptible to brucellosis or tuberculosis, to
herds  regularly  checked  for  these  diseases  under  a  control  plan
approved by the competent authorities,

(ii)

satisfying the requirements of point (a) except point (a)(i).

2.

Raw milk:

(a)

from  animals  which  do  not  show  a  positive  reaction  to  tests  for
tuberculosis  or  brucellosis  nor  any  symptoms  of  these  diseases,  but
belong  to  a  herd  which  does  not  meet  the  requirements  of  point  1  a)  i)
must  only  be  used  after  having  undergone  a  heat  treatment  such  as  to
show a negative reaction to the phosphatase test under the supervision of
the competent authority;

(b)

from  animals  which  do  not  show  a  positive  reaction  to  tests  for
brucellosis nor any symptom of that disease, but belong to a herd which
does not meet the requirements of point 1 b) i) must be used:

(i)

(ii)

only for  the  manufacture of cheese with a  maturation period of  at
least two months, or

after having undergone a heat treatment on the spot such as to show
a negative reaction to the phosphatase test under the supervision of
the competent authority;

(c)

(d)

from  animals  which  do  not  show  a  positive  reaction  to  tests  for
tuberculosis  or  brucellosis  nor  any  symptoms  of  these  diseases,  but
belong to a herd where brucellosis or tuberculosis has been detected after
the  checks  required  in  point  1  c)  i)  must  be  treated  to  ensure  its  safety
under the supervision of the competent authority;

from animals showing individually a positive reaction to the prophylactic
tests  vis-à-vis  tuberculosis  or  brucellosis  as  laid  down  in  Directive
64/432/EEC  and  Directive  91/68/EEC  cannot  be  used  for  human
consumption.

95

3.

4.

If  goats  are  kept  together  with  cows,  they  must  be  inspected  and  tested  for
tuberculosis.

The isolation of animals which are infected, or suspected of being infected, with
any of the diseases referred to in point 1 must be effective to avoid any adverse
effect on the other animals’ milk.

II.

HYGIENE ON MILK-PRODUCTION HOLDINGS

A. Hygiene on milk-production holdings

1. Movable milking equipment, and premises where milk is stored, handled
or  cooled  must  be  so  located  and  constructed  as  to  limit  the  risk  of
contamination of milk.

2. Where  appropriate,  premises  for  the  storage  of  milk  must  have  suitable
refrigeration  equipment,  be  protected  against  vermin  and  have  adequate
separation from premises where animals are housed.

B. Hygiene during milking, collection of raw milk and its transport

1. Milking must be carried out hygienically, ensuring in particular that:

– 

– 

– 

– 

– 

before milking is started, the teats, udder and if necessary adjacent
parts are clean,

the milk is checked; abnormal milk must be withheld,

milk  from  animals  showing  clinical  signs  of  udder  disease  is
withheld,

animals which have been submitted to a treatment likely to transfer
residues  of  medicinal  products  to  the  milk  can  be  identified  and
their milk is withheld,

components  in  teat  dips  or  sprays  do  not  produce  residues  in  the
milk.

2.

3.

4.

Immediately after milking, milk must be held in a clean place designed to
avoid  adverse  effects  on  the  milk.  If  the  milk  is  not  processed  or
collected within 2 hours of milking, it must be cooled to a temperature of
8°C or lower in the case of daily collection, or 6°C or lower if collection
is not daily;

During  transport  to  a  dairy  establishment,  the  cold  chain  must  be
maintained and at arrival in the dairy establishment the temperature of the
milk must not exceed +10°C, unless  the  milk  has been  collected  within
2 hours of milking.

For  technological  reasons  concerning  the  manufacture  of  certain  milk
products,  Member  States  may  grant  derogations  from  the  temperatures
laid down in points 2 and 3 provided the end-product meets the standards
provided for in this Regulation.

96

C. Hygiene of premises, equipment and tools

1.

2.

Equipment and instruments or their surfaces which are intended to come
into  contact  with  milk  (utensils,  containers,  tanks,  etc.  intended  for
milking, collection or transport) must be easy to clean and disinfect and
be maintained in a sound condition. This will require the use of smooth,
washable and non toxic materials.

After use, utensils used for milking, mechanical  milking equipment and
containers  which  have  been  in  contact  with  milk  must  be  cleaned  and
disinfected. After each journey, or after each series of journeys when the
period of time between unloading and the following loading is very short,
but in all cases at least once per day, the containers and tanks used for the
transport  of  raw  milk  to  a  dairy  establishment  must  be  cleaned  and
disinfected before re-use.

D.

Staff hygiene

1.

2.

Persons performing milking and/or handling raw milk must wear suitable
clean clothes.

Persons  performing  milking  must  wash  their  hands  immediately  before
milking and keep them as clean as possible throughout milking. For this
purpose,  suitable  facilities  must  be  available  near  or  adjacent  to  the
place of milking to enable persons performing milking and handling raw
milk to wash their hands and arms.

III.

STANDARDS FOR RAW COW’S MILK

Awaiting the establishment of standards in the context of a more specific legislation
on  the  quality  of  milk  and  milk  products,  the  following  standards  shall  apply  and
their  compliance  checked  on  a  representative  number  of  samples  taken  by  random
sampling:

Plate count and somatic cell count.

Raw cow's milk must meet the following standards:

Plate count 30°C (per ml)

≤ 100 000(*)

Somatic cell count (per ml)

≤ 400 000(**)

(*)

Rolling geometric average over  a two-month period, with at least one  sample
per month.

(**) Rolling geometric average over a three-month period, with at least one sample
per  month. Where production levels  vary  considerably  according  to  season,  a
Member  State  may  be  authorised  to  apply  another  method  of  calculating  the
results for a low lactation period.

Other scientifically validated methods may be used

97

For the manufacture of cheese with a period of ageing or ripening of at least 60 days,
Member States may grant individual or general derogations.

When the standards to be met by raw milk are exceeded, measures must be taken to
correct the situation. When these  standards  are  repeatedly  or  excessively  exceeded,
the  competent  authority  must  be  informed  and  it  shall  ensure  that  appropriate
measures are taken.

IV.

MICROBIOLOGICAL CRITERIA FOR RAW MILK

Member States shall ensure that raw milk intended for direct consumption or for the
manufacture  of  products  whose  manufacturing  process  does  not  include  any
treatment  capable  of  eliminating  pathogenic  micro-organisms,  is  tested  in  order  to
ensure the microbiological safety of the products.

CHAPTER II: MILK PRODUCTS

I.

CONDITIONS FOR ESTABLISHMENTS

1. Where  necessary,  special  conditions  may  be  granted  by  the  competent
authority  in  particular  in  order  to  take  account  of  traditional  production
methods.

2.       Food  business  operators  manufacturing  processed  milk  products  must

ensure that, before processing:

(a)     raw  cow’s  milk  to  be  used  for  the  production  of  processed  milk
products  has  a  plate  count  not  exceeding  300  000  per  ml  at  a
temperature of 30°C, and

(b)     processed cow’s milk to be used for the production of processed milk
products  has  a  plate  count  not  exceeding  100  000  per  ml  at  a
temperature of 30°C.

II.

REQUIREMENTS FOR HEAT-TREATED DRINKING MILK

1.

2.

Upon  acceptance  at  a  dairy  establishment,  milk  must  be  cooled  to  and/or
maintained  at  a  temperature  not  higher  than  +6°C  until  heat-treated,  unless
treated within 4 hours of acceptance.

Awaiting  the  establishment  of  standards  in  the  context  of  a  more  specific
legislation  on  the  quality  of  milk  and  milk  products,  the  following  standards
shall apply:

(a)

Pasteurised milk must:

– 

have been prepared by a treatment involving a high temperature for
a  short  time  (at  least  71.7°C  for  fifteen  seconds)  or  by  a
pasteurisation  process  using  different 
temperature
combinations to obtain an equivalent effect;

time  and 

– 

show a negative reaction to the phosphatase test;

98

– 

– 

be  cooled  immediately  after  pasteurisation  to  a  temperature  not
exceeding 6°C as soon as possible;

be  prepared  from  raw  milk  which,  prior  to  heat  treatment,  has  a
plate  count  at  30°C  below  300  000  per  ml,  where  cow's  milk  is
concerned;  or  from  thermised  milk  as  referred  to  under  III(2)(a)
which,  prior  to  heat  treatment,  has  a  plate  count  at  30°C  below
100 000 per ml, where cow's milk is concerned.

(b) Ultra High Temperature (UHT) milk must:

– 

– 

– 

be prepared by applying to the raw milk a continuous flow of heat
entailing the application of a high temperature for a short time (at
least 135°C for at least one second or a process using different time
and temperature combinations to obtain an equivalent effect ) - the
aim  being  to  destroy  all  residual  spoilage  micro-organisms  and
their  spores  -  and  be  wrapped  using  aseptic  wrapping  in  opaque
containers or containers made opaque by their packaging, of a type
such that chemical, physical and sensoric changes are reduced to a
minimum;

be preserved such that no deterioration can be observed after it has
spent  fifteen  days  in  a  closed  container  at  a  temperature  of  30°C;
where necessary, provision can also be made for a period of seven
days in a closed container at a temperature of 55°C;

be  prepared  from  raw  milk  which,  prior  to  heat  treatment,  has  a
plate  count  at  30°C  below  300  000  per  ml,  where  cow's  milk  is
concerned,  or  from  thermised  or  pasteurised  milk  which,  prior  to
heat  treatment,  has  a  plate  count  at  30°C  below  100 000  per  ml,
where cow's milk is concerned.

Where the UHT milk treatment is applied by direct contact between milk
and steam, the steam must be obtained from potable water and must not
leave deposits of foreign substances in the milk or affect it adversely.

(c)

Sterilised milk must:

– 

– 

– 

be heated and sterilised in hermetically sealed containers, the seals
of which must remain intact;

be preserved such that no deterioration can be observed after it has
spent  fifteen  days  in  a  closed  container  at  a  temperature  of  30°C;
where necessary, provision can also be made for a period of seven
days in a closed container at a temperature of 55°C;

be  prepared  from  raw  milk  which,  prior  to  heat  treatment,  has  a
plate  count  at  30°C  below  300  000  per  ml,  where  cow's  milk  is
concerned,  or  from  thermised  or  pasteurised  milk  which,  prior  to
heat  treatment,  has  a  plate  count  at  30°C  below  100  000  per  ml,
where cow's milk is concerned;

99

III.

REQUIREMENTS FOR OTHER MILK PRODUCTS

1.

2.

Upon  acceptance  at  a  dairy  establishment,  milk  must  be  cooled  to  and/or
maintained  at  a  temperature  not  higher  than  +6°C  until  processed.  For  the
manufacture  of  milk  products  with  raw  milk,  the  operator  or  manager  of  the
dairy establishment must take all necessary measures to ensure that raw milk is
kept  at  a  temperature  below  +6°C  awaiting  its  processing,  or  is  processed
immediately  after  milking  is  finished.  However,  for  technological  reasons
concerning the manufacture of  certain milk products,  the competent  authority
may authorise the above temperature to be exceeded.

Awaiting  the  establishment  of  standards  in  the  context  of  a  more  specific
legislation on the quality of milk and milk products, milk subject to a treatment
involving heating and intended for the manufacture of milk products must satisfy
the following conditions:

(a)

Thermised milk must:

– 

– 

– 

be  obtained  from  raw  milk  which,  prior  to  heat  treatment,  has  a
plate  count  at  30°C  below  300  000  per  ml,  where  cow's  milk  is
concerned;

be  prepared  from  raw  milk  which  has  been  heated  for  at  least
15 seconds at a temperature between 57°C and 68°C such that after
treatment  the  milk  shows  a  positive  reaction  to  the  phosphatase
test;

if  it  is  used  for  the  production  of  pasteurised,  UHT  or  sterilised
milk intended for the manufacture of milk products, comply before
treatment with the following standards: plate count at 30°C below
100 000 per ml;

(b)

Pasteurised milk must:

– 

be prepared by means of a treatment involving a high temperature
for  a  short  time  (at  least  71.7°C  for  fifteen  seconds)  or  by  a
pasteurisation  process  using  different 
temperature
combinations to obtain an equivalent effect;

time  and 

– 

show a negative reaction to the phosphatase test;

(c) UHT  milk  must  be  prepared  by  applying  to  the  raw  milk  a  continuous
flow  of  heat  entailing  the  application  of  a  high  temperature  for  a  short
time  (at  least  135°C  for  at  least  one  second  or  by  a  process  using
different time/temperature combinations to obtain an equivalent effect) -
the  aim  being  to  destroy  all  micro-organisms  and  their  spores  -  be
wrapped using aseptic wrapping in opaque containers or containers made
opaque  by  their  packaging,  of  a  type  such  that  chemical,  physical  and
organoleptic changes are reduced to a minimum.

100

CHAPTER III: WRAPPING AND PACKAGING

Sealing must be carried out immediately after filling in the establishment where the last heat
treatment  of  the  drinking  milk  and/or  liquid-milk  products  has  taken  place,  by  means  of
sealing  devices  which  ensure  the  protection  of  milk  against  any  harmful  effects  of  external
origin  on  its  characteristics.  The  sealing  system  must  be  designed  in  such  a  way  that  after
opening, the evidence of its opening remains clear and easy to check.

CHAPTER IV: LABELLING

Without prejudice to the provisions of Directive 79/112/EEC, labelling must clearly show for
inspection purposes:

1.

2.

The words "raw milk" for raw milk intended for direct human consumption.

In the case of heat-treated milk and heat treated liquid milk products:

– 

– 

– 

the  nature  of  the  heat  treatment  to  which  the  milk  has  been  submitted,  e.g.
thermised, pasteurised, UHT or sterilised,

any indication, whether coded or not, making it possible to identify the date of
the last heat treatment,

for pasteurised milk, the temperature at which the product must be stored.

3.

In the case of milk products:

– 

– 

– 

the  words  "made  with  raw  milk"  or  "made  with  thermised  milk"  on  milk
products manufactured from non-heat-treated milk or from thermised milk and
where the manufacturing process does not include any heat treatment,

on  milk  products  heat-treated  at  the  end  of  the  manufacturing  process,  the
nature of this treatment,

on pasteurised liquid-milk products, the temperature at which the product must
be stored.

CHAPTER V: HEALTH MARKING

By way of derogation from the health marking requirements laid down in the preface to the
present  Annex,  the  approval  number  in  the  health  mark  may  be  replaced  by  a  reference  to
where the approval number of the establishment is shown.

CHAPTER VI: APPROVAL AND REGISTRATION OF ESTABLISHMENTS

Dairy  establishments  shall  be  approved  by  the  competent  authority  in  accordance  with  the
preface to the present Annex.

Dairy establishments serving the local market may be registered.

101

1.

2.

3.

SECTION X: EGGS AND EGG PRODUCTS

CHAPTER I: EGGS

At the producer's premises and until sale to the consumer, eggs must be kept clean,
dry,  free  of  extraneous  odour,  effectively  protected  from  shocks  and  out  of  direct
sunshine. They must be stored and transported at a temperature which is best suited
to assure optimal conservation of their hygiene properties.

Eggs must be delivered to the consumer within a maximum time limit of 21 days of
laying.

In  respect  of  salmonella,  the  following  rules  shall  apply  for  eggs  intended  for
Sweden and Finland:

(a)      consignments of eggs must originate from flocks which have been subjected to
microbiological sampling defined in accordance with the procedure referred to
in Article 9;

(b)     the  test  provided for in (a) is  not  required  for  consignments  of  eggs  intended

for the manufacture of egg products in an egg product establishment;

(c)      the  guarantees  provided  in  (a)  are  not  required  for  eggs  originating  in  an
establishment  subject  to  an  operational  programme  recognised  by  the
Commission  in  accordance  with  the  procedure  referred  to  in  Article  9  as
equivalent  to  that  approved  for  Sweden  and  Finland.  The  operational
programmes  of  the  Member  States  may  be  amended  and  updated  by  the
Commission in accordance with the same procedure.

CHAPTER II: EGG PRODUCTS

I.

CONDITIONS FOR ESTABLISHMENTS

Establishments for the manufacture of egg products must have at least:

1.

suitable rooms with appropriate equipment for

(a) washing and disinfecting dirty eggs, if necessary;

(b)

breaking  eggs  and  collecting  their  contents  and  removing  the  parts  of
shells and membranes;

2.

a separate room for operations other than those referred to in point 1.

Where  egg  products  are  pasteurised,  this  may  be  done  in  the  room  referred  to  in
point 1(b), when the establishment has a closed pasteurisation system. All measures
must be taken to prevent contamination of egg products after their pasteurisation.

102

II.

RAW MATERIALS FOR THE MANUFACTURE OF EGG PRODUCTS

Only non-incubated eggs fit for human consumption may be used in the manufacture
of egg products; their shells must be fully developed and contain no breaks. However,
cracked  eggs  may  be  used  for  the  manufacture  of  egg  products  provided  they  are
delivered  directly  by  the  packaging  centre  or  production  farm  to  an  approved
establishment, where they must be broken as soon as possible.

Liquid  egg obtained in  an establishment approved for that  purpose  may  be  used  as
raw material. Liquid egg must be obtained under the following conditions:

1.

2.

3.

The conditions referred to under III points 1 to 4 must be observed.

Immediately after production, the products must have been either deep-frozen
or chilled to a temperature of not more than 4°C; in the latter case they must be
treated  at  their  place  of  destination  within  the  48  hours  from  the  time  of
breaking  of  the  eggs  from  which  they  were  obtained,  except  in  the  case  of
ingredients to be de-sugared;

The  nature  of  the  goods  must  be  indicated  as  follows:  "non-pasteurised  egg
products - to be treated at place of destination - date and hour of breaking -";

III.

SPECIAL  HYGIENE  REQUIREMENTS  FOR  THE  MANUFACTURE  OF
EGG PRODUCTS

All  operations  must  be  carried  out  in  such  a  way  as  to  avoid  any  contamination
during production, handling and storage of egg products, and in particular:

1.

2.

3.

4.

5.

Dirty eggs must be washed before breaking.

Eggs must be broken in the room provided for that purpose; cracked eggs must
be processed without delay.

Eggs  other  than  those  of  hens,  turkeys  or  guinea  fowl  must  be  handled  and
processed  separately.  All  equipment  must  be  cleaned  and  disinfected  when
processing of hens', turkeys' and guinea fowls' eggs is resumed.

Egg contents may  not be obtained by the centrifuging or crushing of  eggs, nor
may centrifuging be used to obtain the remains of egg whites from empty shells
for human consumption.

After  breaking,  each  particle  of  egg  product  must  undergo  a  treatment  as
quickly as  possible to eliminate microbiological hazards  or  to reduce  them to
an  acceptable  level.  A  batch  which  has  been  insufficiently  treated  may
immediately undergo treatment again in the same establishment, provided that
this treatment renders it fit for human consumption; where a batch is found to
be unfit for human consumption, it must be denatured.

A treatment is not required for egg white intended for the manufacture of dried
or crystallised albumin intended to undergo a later pasteurisation treatment;

103

6.

7.

If  treatment  is  not  carried  out  immediately  after  breaking,  the  egg  contents
must be stored either frozen or at a temperature not exceeding 4°C; the storage
period  at  4°C  must  not  exceed  48  hours,  except  for  stabilised  products  (e.g.
with salt or sugar) and egg products to be de-sugared;

Products  which  have  not  been  stabilised  so  as  to  be  kept  at  room  temperature
must be cooled to a temperature not exceeding 4°C ; products for freezing must
be frozen immediately after treatment;

IV.

ANALYTICAL SPECIFICATIONS

1.

2.

3.

The concentration of 3 OH-butyric acid must not exceed 10 mg/kg in the dry
matter of the unmodified egg product.

The lactic acid content must not exceed 1 000 mg/kg of egg product dry matter
(applicable only to the untreated product).

However, for fermented products, this value should be the one recorded before
the fermentation process.

The quantity of eggshell remains, egg membranes and any other particles in the
egg product must not exceed 100 mg/kg of egg product.

V.

LABELING OF EGG PRODUCTS

Every consignment of egg products leaving an establishment must carry, in addition
to  the  general  requirements  for  health  marking,  a  label  giving  the  temperature  at
which the egg products must be maintained and the period during which conservation
may thus be assured.

VI.

APPROVAL AND REGISTRATION OF ESTABLISHMENTS

The  premises  of  collectors  and  egg  packaging  centres  shall  be  registered.
Establishments manufacturing egg products shall be approved and  given an approval
number in accordance with the preface to this Annex.

SECTION XI: FROGS' LEGS

1.

2.

3.

Frogs  may  only  be  killed  using  humane  slaughter  techniques  in  an  establishment
approved for that purpose. Frogs which are found to be dead prior to slaughter must
not be prepared for human consumption.

A special room must be reserved for the storage and washing of live frogs, and for
their  slaughter  and  bleeding.  This  room  must  be  physically  separate  from  the
preparation room.

Immediately following preparation, the frogs' legs must be washed fully with running
potable  water  within  the  meaning  of  Council  Directive  98/83/EC,  and  immediately
chilled to the temperature of melting ice or frozen to a temperature of at least -18°C
or processed.

104

4.

1.

2.

3.

The  frogs'  legs  must  not  contain,  in  their  edible  parts,  contaminants  such  as  heavy
metals or organo-halogen substances at such a level that the calculated dietary intake
exceeds the acceptable daily or weekly human intake.

SECTION XII: SNAILS

Snails  may only be killed using humane  methods  in  an  establishment  approved  for
that purpose. Snails that are found to be dead before being killed must not be used for
human consumption.

The hepato-pancreas must be removed and must not be used for human consumption.

Snails must not contain, in their edible parts, contaminants such as heavy metals or
organo-halogen substances at such a level that the calculated dietary intake exceeds
the acceptable daily or weekly human intake.

SECTION XIII: RENDERED ANIMAL FATS AND GREAVES

A.

Standards applicable to establishments collecting or processing raw materials

1.

Centres  for  collection  of  raw  materials  and  further  transport  to  processing
establishments  must  be  equipped  with  a  cold  store  for  the  storage  of  raw
materials  at  a  temperature  of  7°C  or  below,  unless  the  raw  materials  are
collected and rendered within 12 hours after they were obtained.

2.

The processing establishment must be approved and have at least:

(a)

(b)

(c)

a cold  store,  unless  the  raw  materials  are  collected  and  rendered  within
12 hours after they were obtained;

a dispatch room, unless the establishment dispatches rendered animal fat
only in tankers;

if  appropriate,  suitable  equipment  for  the  preparation  of  products
consisting  of  rendered  animal  fats  mixed  with  other  foodstuffs  and/or
seasonings;

B.

Hygiene for rendered animal fat, greaves and by-products

1.

2.

Raw materials must come from animals which, following ante-mortem and post-
mortem inspection, have been found fit for human consumption.

The raw materials must consist of adipose tissues or bones which are reasonably
free from blood and impurities.

105

3.

(a)

For the preparation of rendered animal fat, only adipose tissues or bones
collected  at  slaughterhouses,  cutting  premises  or  meat  processing
establishments  may  be  used.  Raw  materials  must  be  transported  and
stored  until  rendering  in  hygienic  conditions  and  at  an  internal
temperature of 7°C or below;(b)

by way of derogation from (a),

– 

– 

raw  materials  may  be  stored  and  transported  unrefrigerated
provided that they are rendered within twelve hours after they were
obtained;

raw  materials  collected  in  retail  shops  or  in  premises  adjacent  to
points of  sale  where  the  cutting  and  storage  of  meat  is  performed
for the sole purpose  of supplying the  final consumer  directly  may
be  used  for  the  preparation  of  rendered  animal  fat,  provided  they
are in satisfactory hygiene condition and properly packaged. When
the  raw  materials  are  not  collected  daily,  they  must  be  chilled
immediately after collection.

4.

5.

Raw materials must be rendered by heat, pressure or other appropriate method,
followed by separation of the fat by decantation, centrifuging, filtration or other
appropriate method. The use of solvents is prohibited.

Rendered  animal  fat  prepared  in  accordance  with  points  1,  2,  3  and  4  may  be
refined  in  the  same  establishment  or  in  another  establishment  with  a  view  to
improving  its  physico-chemical  quality  when  the  fat  for  refining  meets  the
standards laid down in point 6.

106

6.

Rendered animal fat, depending on type, must meet the following standards:

Ruminants

Pigs

Other animal fat

Edible tallow

Tallow
for
refining

Edible pig fat

Lard and
other pig
fat for
refining

Edible

For
refining

Premier
jus(1)

Other

Lard(2)

Other

0.75

1.25

3.0

0.75

1.25

2.0

1.25

3.0

4 meq/kg 4 meq/kg 6 meq/kg 4 meq/kg 4 meq/kg 6 meq/kg 4 meq/kg

10
meq/kg

Maximum 0.15%

Maximum 0.5%

Normal

FFA
(m/m%
oleic
acid)
maximum

Peroxide
maximum

Total
insoluble
impurities

Odour,
taste,
colour

(1)

(2)

Rendered  animal  fat  obtained  by  low-temperature  rendering  of  fresh  fat  from  the  heart,  caul,
kidneys and mesentery of bovine animals, and fat from cutting rooms.

Fresh fat obtained from rendering the adipose tissues of swine.

7.

Greaves intended for human consumption must be stored:

(i) when rendered at a temperature of 70°C or less: at a temperature of less
than 7°C for a period not exceeding 24 hours, or at -18° C or below;

(ii) when rendered at a temperature of more than 70°C and having a moisture

content of 10% (m/m) or more:

– 

at  a  temperature  of  less  than  7°C  for  a  period  not  exceeding  48
hours or a time/temperature ratio giving an equivalent guarantee,

– 

at -18°C or below;

(iii) when rendered at a temperature of more than 70°C and having a moisture

content of less than 10% (m/m): no specific requirement.

SECTION XIV: TREATED STOMACHS, BLADDERS AND INTESTINES

I.

In establishments treating stomachs,  bladders  and intestines  it  must  be ensured that
products which cannot be kept at ambient temperature are stored until their dispatch
in  rooms  intended  for  that  purpose.  In  particular,  products  which  are  not  salted  or
dried must be kept at a temperature not exceeding 3°C.

107

II.

Animal intestines, bladders and stomachs may only be placed on the market if:

(a)

(b)

(c)

(d)

the  intestines,  bladders  or  stomachs  come  from  animals  that  have  been
slaughtered  in  a  slaughterhouse  under  the  supervision  of  the  competent
authority and have undergone ante- and post-mortem inspection;

the intestines, bladders or stomachs come from establishments approved by the
competent authority;

the intestines, bladders or stomachs have been cleaned and scraped, then salted,
heated or dried;

after  the  treatment  referred  to  in  (c),  effective  measures  have  been  taken  to
prevent re-contamination of the intestines, stomachs or bladders.

Animal intestines, bladders and stomachs may only be imported from third countries
upon  presentation  of  a  certificate  issued  and  signed  by  an  official  veterinarian
attesting the above.

SECTION XV: GELATINE

CHAPTER I: REQUIREMENTS FOR RAW MATERIALS

1.

For  the  production  of  gelatine  intended  for  human  consumption,  the  following  raw
materials may be used:

– 

– 

– 

– 

– 

– 

– 

bones

hides and skins of farmed ruminant animals

pig skins

poultry skin,

tendons and sinews,

wild game hides and skins,

fish skin and bones.

2.

3.

4.

The  use  of  bones  obtained  from  ruminant  animals  born,  reared  or  slaughtered  in
countries  or  regions  classified  as  high  BSE  risk  in  accordance  with  Community
legislation is prohibited.

The use of hides and skins submitted to tanning processes is prohibited.

Raw  materials  listed  in  the  first  five  indents  of  paragraph  1  shall  be  derived  from
animals which have been slaughtered in a slaughterhouse and  whose  carcases  have
been  found  fit  for  human  consumption  following  ante-and  post-mortem  inspection,
or  in  the  case  of  wild  game  hides  and  skins  from  wild  game  found  fit  for  human
consumption.

108

5.

Raw  materials  must  come  from  food  premises  approved  or  registered  under  the
present Regulation.

Collection  centres  and  tanneries  which  intend  to  supply  raw  material  for  the
production  of  gelatine  intended  for  human  consumption  must  be  specifically
authorised  or registered  for  this purpose  by  the  competent  authorities  and  fulfil  the
following requirements:

(a)

(b)

(c)

they  must  have  storage  rooms  with  hard  floors  and  smooth  walls  which  are
easy  to clean  and disinfect  and  where  appropriate  provided  with  refrigeration
facilities;

the storage rooms must be kept in a satisfactory state of cleanliness and repair,
so that they do not constitute a source of contamination for the raw materials;

if raw material not in conformity to this part is stored and/or processed in these
premises, it must be segregated from raw material in conformity with this part
throughout the period of receipt, storage, processing and dispatch.

6.

Imports  into  the  Community  of  raw  materials  for  the  production  of  gelatine  for
human consumption are subject to the following provisions:

–  Member  States  may  authorise  the  importation  of  this  raw  material  only  from

third countries which appear on a the list drawn-up for that purpose;

– 

each  consignment  must  be  accompanied  by  a  certificate  that  conforms  to  the
model to be laid down.

CHAPTER II: TRANSPORT AND STORAGE OF RAW MATERIALS

1.

2.

During  transportation,  at  the  time  of  delivery  to  a  collection  centre,  tannery  and
gelatine-processing  establishment,  raw  materials  must  be  accompanied  by  a
document stating the origin of the raw materials.

Raw  materials  must  be  transported  and  stored  chilled  or  frozen  unless  they  are
processed within 24 hours after their departure.

However,  degreased  and  dried  bones  or  ossein,  salted,  dried  and  limed  hides  and
hides and skins treated with alkali or acid may be transported and stored at ambient
temperature.

109

CHAPTER III: CONDITIONS TO BE COMPLIED WITH IN THE MANUFACTURE
OF GELATINE

1.

Gelatine must be produced by a process which ensures that:

– 

– 

all  ruminant  bone  material  which  is  derived  from  animals  born,  reared  and
slaughtered  in  countries  or  regions  classified  as  low  BSE  risk  in  accordance
with  Community  legislation  is  subjected  to  a  process  which  ensures  that  all
bone material is finely crushed and degreased with hot water and treated with
dilute hydrochloric acid (at minimum concentration of 4% and pH < 1.5) over
a  period  of  at  least  two  days,  followed  by  an  alkaline  treatment  of  saturated
lime solution (pH>12.5) for a period of at least 20 days with a sterilisation step
of 138-140 °C during four seconds or by an equivalent process approved by the
Commission after consultation of the European Food Safety Authority,

other raw materials is subjected to a treatment with acid or alkali, followed by
one  or more rinses.  The pH must be  adjusted subsequently.  Gelatine  must  be
extracted  by  heating  one  or  several  times  in  succession,  followed  by
purification by means of filtration and sterilisation.

2.

3.

The  use  of  preservatives,  other  than  sulphur  dioxide  and  hydrogen  peroxide,  is
prohibited.

Provided  the  requirements  for  gelatine  not  intended  for  human  consumption  are
exactly  the  same  as  for  gelatine  intended  for  human  consumption,  production  and
storage may be undertaken in the same establishment.

CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS

Limits for residues

Limit

1 ppm

5 ppm

0.5 ppm

0.15 ppm

10 ppm

30 ppm

50 ppm

15%

2%

50 ppm

10 ppm

Elements

As

Pb

Cd

Hg

Cr

Cu

Zn

Moisture (105°C)

Ash (550°C)

SO² ( Reith Williams)

H²O² (European
Pharmacopia 1986
(V²O²))

110

ANNEX III

IMPORTATION OF PRODUCTS OF ANIMAL ORIGIN FROM THIRD
COUNTRIES

I.

PROVISIONS  FOR  DRAWING  UP  LISTS  OF  THIRD  COUNTRIES  FROM
WHICH 
IMPORTS  OF  PRODUCTS  OF  ANIMAL  ORIGIN  ARE
PERMITTED

In order to ensure compliance with the general provisions referred to in Article 11 of
Regulation (EC) No 178/2002, the following shall apply:

(a)

Lists  of  the  third  countries  or  parts  of  third  countries  from  which  imports  of
products  of  animal  origin  are  permitted  shall  be  drawn  up,  where  necessary
after a Community inspection visit.

When drawing up these lists, particular account must be taken of:

(i)

the legislation of the third country;

(ii)

(iii)

(iv)

(v)

(vi)

the organisation of the competent authority of the third country and of its
inspection services, of the powers of these services and the supervision to
which they are subject, as well as the authority that these services have to
monitor effectively the application of their legislation;

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

assurances  which  the  third  country  can  give  regarding  compliance  or
equivalence with the relevant health conditions;

experience of placing marketing of the product from the third country on
the market and the results of import controls carried out;

the results of Community inspection and/or audits carried out in the third
country,  in  particular  the  results  of  the  assessment  of  the  competent
authorities;

(vii) the state of health of the livestock, other domestic animals and wildlife in
the  third  country  and  the  general  health  situation  in  the  country,  which
might endanger public health in the Community;

(viii) the regularity and rapidity of the information supplied by the third country
relating  to  the  presence  of  biological  hazards,  including  the  presence  of
marine biotoxins in fishing or aquaculture zones;

111

(ix)

(x)

the  existence,  implementation  and  communication  of  a  zoonoses  control
programme.

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

(xi)

the  existence,  implementation  and  communication  of  a  residue  control
programme;

(xii) the  legislation  of  the  third  country  on  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)

For  each  product  or  group  of  products,  special  import  conditions  shall  be  laid
down for each third country or for groups of third countries, having regard to the
health situation of the third country or countries concerned.

The special import conditions shall include:

(i)

(ii)

identification of the competent authority responsible for official controls
on the products concerned and for signing health certificates,

details  of  the  health  certification  which  must  accompany  consignments
destined for the Community; these certificates must:

– 

– 

– 

– 

be  drawn  up  in  at  least  one  of  the  languages  of  the  country  of
dispatch and of destination and one of those of the Member State in
which the inspections at the border inspection post are carried out,

accompany the products in their original version,

consist of a single sheet of paper,

be made out for a single consignee;

Certificates must be issued on the day on which the products are loaded
with a view to dispatch to the country of destination.

(iii)

affixing  of  a  health  mark  identifying  products  of  animal  origin,  in
particular by identification of the third country of dispatch (the country’s
full  name  or  its  ISO  abbreviation)  and  the  approval  number,  name  and
address of the establishment of origin;

(c) where  considered  appropriate,  general  import  conditions  for  a  given  product

may be laid down.

112

II.

CONDITIONS  FOR  DRAWING  UP  AND  UP-DATING  LISTS  OF
ESTABLISHMENTS,  INCLUDING  FACTORY  VESSELS  AND  FREEZER
VESSELS

Establishments,  factory  vessels  or  freezer  vessels  and,  with  regard  to  live  bivalve
molluscs,  production  and  harvesting  areas,  shall  only  dispatch  products  of  animal
origin to the Community when they figure on the lists to be established and kept up-
to-date in accordance with the following procedures:

1.

Equivalence agreements.

The lists of establishments must be drawn up and updated in accordance with
the provisions of the relevant equivalence agreement.

2.

By the Community.

In  the  case  of  a  favourable  outcome  of  the  Commission  controls  referred  to
under I,:

(a)

Lists  must  be  adopted  on  the  basis  of  a  communication  from  the
competent authorities of the third country to the Commission.

(i) An  establishment  may  be  placed  on  a  list  only  if  it  is  officially
approved by the competent authority of the third country exporting
to the Community. Such approval is subject to

– 

– 

compliance with Community requirements;

supervision  by  an  official  inspection  service  in  the  third
country.

(ii) A  production  or  harvesting  area  for  live  bivalve  molluscs  must
the

legislation  applicable  within 

the  relevant 

comply  with 
Community.

(iii) The approval of factory vessels and freezer vessels must be carried

out:

– 

– 

by the competent authority of the third country of which the
vessel is flying the flag,

or  by  the  competent  authority  of  another  third  country,  on
condition  that  such  third  country  figures  on  the  Community
list  of  third  countries  authorised  to  import  fishery  products
into the Community and that the fishery products are landed
regularly  on  its  territory  and  inspected  by  its  competent
authority, which must also apply health marks to the products
and issue the health certificates,

– 

or by a Member State.

113

(b) Approved lists shall be amended as follows:

– 

– 

– 

– 

the  Commission  shall 
the
modifications proposed by the third  country concerned to  the  lists
of  establishments  within  five  working  days  of  the  receipt  of  the
proposed modifications;

the  Member  States  of 

inform 

the Member States shall have ten woking days, from receipt of the
modifications  to  the  lists  of  establishments  referred  to  above  to
send any written comments to the Commission;

where  no  comments  are  received  from  the  Member  States  within
the time limit laid down in the above indent, the amendments to the
lists  shall  be  considered  to  have  been  accepted  by  the  Member
States  and  imports  shall  be  authorised  from  such  establishments
when  the  Commission  notifies  the  competent  authorities  of  the
Member  States  and  third  country  concerned  that  the  amendments
are published on the website of the Commission.

where  written  comments  are  made  by  at  least  one  Member  State,
the  Commission  shall  inform  the  Member  States  and  include  the
point on the next meeting of the Standing Veterinary Committee on
the Food Chain and Animal Health for decision;

3.

Community  authorisation  to  a  third  country  to  draw  up  and  up-date  lists  of
establishments.

Following  a  Commission  on-the-spot  inspection  and/or  audit  for  the  criteria
listed in point I, the competent authority of a third country may be granted the
possibility to draw up and up-date lists, on the following conditions:

(a) An establishment may be placed on a list only if it is officially approved
by  the  competent  authority  of  the  third  country  exporting  to  the
Community. Such approval is subject to:

– 

– 

compliance with Community requirements;

effective  supervision  by  an  official  inspection  service  in  the  third
country.

Each establishment must be given an approval number.

114

(b) The approval of factory vessels and freezer vessels is to be carried out by
the competent authority of the third country of which the vessel is flying
the flag,

(c)

The  approval  of  production  and  harvesting  areas  for  live  bivalve
molluscs  is  subject  to  compliance  with  the  rules  applicable  for  that
purpose within the Community.

(d)

In  the  event  of  non-compliance  with  the  Community  requirements,  the
competent authority must have real powers

– 

– 

to ensure correction of deficiencies within an appropriate time-limit
and

to ensure suspension of the activities for export to the Community
or  withdrawal  of  approved  establishments,  factory  and  freezer
vessels,  and  production  and  harvesting  areas  of  live  bivalve
molluscs under its responsibility, where it is not possible to correct
deficiencies  within  an  appropriate  time-limit  or  where  a  risk  to
public health has been identified.

(e) An  up-to-date  list  is  to  be  transmitted  by  the  competent  authority  in  a
third  country  to  the  Commission,  which  makes  it  available  to  any
interested third party on a dedicated site on the Internet.

Only  establishments  appearing  on  this  list  may  dispatch  products  of  animal
origin to the Community.

4.

Case-by-case decisions.

To  deal  with  specific  situations,  imports  may  be  authorised  directly  from  an
establishment  of  a  third  country  where  the  latter  is  unable  to  provide  the
guarantees referred to under I. In this event, the establishment in question must
receive  special  approval  following  a  Commission  inspection.  The  approval
decision  must  fix  the  specific  import  conditions  to  be  followed  for  products
coming from that establishment.

III.

OTHER PROVISIONS

1.

Only products from a third country which

– 

are  prepared  in  the  third  country  of  dispatch  or,  with  regard  to  fishery
products,  on  factory  vessels  or  freezer  vessels  of  the  third  country  of
dispatch;

115

– 

– 

are obtained or prepared in another third country than the third country of
dispatch, provided the product comes from an approved establishment in
a third country appearing on a Community list;

where  appropriate,  are  prepared  in  the  Community  or  manufactured
therein,

may be imported into the Community.

2.

If  necessary,  special  conditions  for  the  importation  of  products  intended  for
specific purposes may be adopted as necessary.

116