Common Position (EC) No 2/2004 of 27 October 2003 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a regulation of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin
Date: 2003-10-27
Institutions: Council of the European Union
Subjects: EC Regulation, animal product, common position, food hygiene, food safety, foodstuff, foodstuffs legislation

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C 48 E/23

COMMON POSITION (EC) No 2/2004

adopted by the Council on 27 October 2003

with a view to the adoption of a Regulation (EC) No . . ./2004 of the European Parliament and of
the Council of . . . laying down specific hygiene rules for food of animal origin

(2004/C 48 E/02)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

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

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

establishments,
procedures
requirements for storage and transport and health marks.

approval

the

for

of

(5) These principles constitute a common basis

the
hygienic production of food of animal origin, permitting
the simplification of the existing Directives.

for

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

(6)

It is desirable to achieve further simplification by applying
the same rules wherever appropriate to all products of
animal origin.

After consulting the Committee of the Regions,

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

Whereas:

(1) By Regulation (EC) No . . ./2004 (4),

Parliament and the Council
food business operators on the hygiene of foodstuffs.

the European
laid down general rules for

(2) Certain foodstuffs may present specific hazards to human
health, requiring the setting of specific hygiene rules. This
is particularly the case for food of animal origin, in which
microbiological and chemical hazards have frequently
been reported.

(3)

In the context of the common agricultural policy, many
Directives have been adopted to establish specific health
rules for the production and placing on the market of the
products listed in Annex I to the Treaty. These health rules
have reduced trade barriers for the products concerned,
contributing to the creation of the internal market while
ensuring a high level of protection of public health.

(4) With regard to public health, these rules contain common
principles, in particular in relation to the manufacturers'
structural,
and competent
operational and hygiene requirements for establishments,

responsibilities,

authorities'

(1) OJ C 365 E, 19.12.2000, p. 58.
(2) OJ C 155, 29.5.2001, p. 39.
(3) Opinion of the European Parliament of 15 May 2002 (OJ C 180 E,
31.7.2003, p. 288), Council Common Position of 27 October 2003
and Position of the European Parliament of . . . (not yet published in
the Official Journal).

(4) See page 1 of this Official Journal.

carrying out

(7) The requirement in Regulation (EC) No . . ./2004 whereby
any stage of
food business operators
production, processing and distribution of
food after
primary production and associated operations must put
in place,
implement and maintain procedures based on
hazard analysis and critical control point (HACCP) prin-
ciples also permits simplification.

(8) Taken together, these elements justify a recasting of the
specific hygiene rules contained in existing Directives.

(9) The principal objectives of the recasting are to secure a
high level of consumer protection with regard to food
in particular by making food business operators
safety,
to the same rules,
throughout
and to ensure the proper functioning of
the internal
market in products of animal origin, thus contributing
to the achievement of the objectives of the common agri-
cultural policy.

the Community subject

(10) It is necessary to maintain and, where required to ensure
consumer protection, to tighten detailed hygiene rules for
products of animal origin.

storage of

(11) Community rules should not apply either to primary
production for private domestic use or to the domestic
preparation, handling or
food for private
domestic consumption. Moreover, where small quantities
of primary products or of certain types of meat are
supplied
operator
producing them to the final consumer or to a local
retail establishment,
is appropriate to protect public
health through national law, in particular because of the
close relationship between the producer and the consumer.

business

directly

food

the

by

it

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(12) The requirements of Regulation (EC) No . . ./2004 are
generally sufficient to ensure food safety in establishments
carrying out retail activities involving the direct sale or
supply of food of animal origin to the final consumer.
This Regulation should generally apply to wholesale
activities (that is, when a retail establishment carries out
operations with a view to supplying food of animal origin
to another establishment). Nevertheless, with the exception
of the specific temperature requirements laid down in this
(EC)
the
Regulation,
No . . ./2004 should suffice
activities
consisting only of storage or transport.

for wholesale

requirements

Regulation

of

they consider

(13) Member States should have some discretion to extend or
to limit the application of the requirements of this Regu-
law. However, they may
lation to retail under national
limit
the
their application only if
requirements of Regulation (EC) No . . ./2004 are sufficient
to achieve food hygiene objectives and when the supply of
food of animal origin from a retail establishment
to
another
localised and
is
restricted activity. Such supply should therefore be only
a small part of the establishment's business; the estab-
lishments supplied should be situated in its immediate
vicinity; and the supply should concern only certain
types of products or establishments.

establishment

a marginal,

that

(14) In accordance with Article 10 of

the Treaty, Member
States are to take all appropriate measures to ensure that
food business operators comply with the obligations laid
down in this Regulation.

(15) The traceability of food is an essential element in ensuring
food safety.
In addition to complying with the general
rules of Regulation (EC) No 178/2002 (1), food business
operators responsible for establishments that are subject to
approval in accordance with this Regulation should ensure
that all products of animal origin that they place on the
market bear either a health mark or an identification
mark.

requirements

(16) Food imported into the Community is to comply with the
general
laid down in Regulation (EC)
No 178/2002 or to satisfy rules that are equivalent to
specific
Community
hygiene requirements for food of animal origin imported
into the Community.

rules. This Regulation defines

Community and confirmed by Decisions 94/968/EC (2),
95/50/EC (3), 95/160/EC (4), 95/161/EC (5), 95/168/EC (6),
95/409/EC (7), 95/410/EC (8) and 95/411/EC (9). It should
establish a procedure for the granting, for a transitional
period, of guarantees to any Member State that has an
approved national control programme which,
the
food of animal origin concerned,
is equivalent to those
approved for
Finland and Sweden. Regulation (EC)
No 2160/2003 of the European Parliament and of the
Council of 17 November 2003 on the control of
salmonella
specified food-borne zoonotic
agents (10) provides for a similar procedure in respect of
live animals and hatching eggs.

and other

for

(18) It

is

for

appropriate

and hygiene
the
requirements laid down in this Regulation to apply to all
types of establishments,
including small businesses and
mobile slaughterhouses.

structural

for regions that are subject

referred to in Article 299(2) of
should

(19) Flexibility is appropriate to enable the continued use of
traditional methods at any of the stages of production,
processing or distribution of
food and in relation to
structural requirements for establishments. Flexibility is
particularly important
to
special geographical constraints, including the outermost
the Treaty.
regions
However,
food
hygiene objectives. Moreover, since all food produced in
accordance with the hygiene rules will normally be in free
the procedure
circulation throughout
allowing Member States to exercise flexibility should be
fully transparent. It should provide, where necessary to
resolve disagreements, for discussion within the Standing
Committee on the Food Chain and Animal Health estab-
lished by Regulation (EC) No 178/2002.

the Community,

compromise

flexibility

not

(20) The definition of mechanically separated meat

(MSM)
covering all methods of
should be a generic one
mechanical separation. Rapid technological developments
in this area mean that a flexible definition is appropriate.
The
for MSM should differ,
however, depending on a risk assessment of the product
resulting from different methods.

requirements

technical

(21) There are interactions between food business operators,
including
and connections
between animal health, animal welfare and public health
considerations at all stages of production, processing and

feed sector,

animal

the

(17) The adoption of this Regulation should not reduce the
level of protection provided by the additional guarantees
agreed for Finland and Sweden on their accession to the

(1) Regulation (EC) No 178/2002 of the European Parliament and of
the Council of 28 January 2002 laying down the general principles
and requirements of
food law, establishing the European Food
Safety Authority and laying down procedures in matters of food
safety (OJ L 31, 1.2.2002, p. 1).

(2) OJ L 371, 31.12.1994, p. 36.
(3) OJ L 53, 9.3.1995, p. 31.
(4) OJ L 105, 9.5.1995, p. 40.
(5) OJ L 105, 9.5.1995, p. 44.
(6) OJ L 109, 16.5.1995, p. 44.
(7) OJ L 243, 11.10.1995, p. 21.
(8) OJ L 243, 11.10.1995, p. 25.
(9) OJ L 243, 11.10.1995, p. 29.
(10) OJ L 325, 12.12.2003, p. 1.

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communication
distribution. This
between the different stakeholders along the food chain
from primary production to retail.

adequate

requires

(22) In order to ensure proper inspection of hunted wild game
placed on the Community market, bodies of hunted
animals and their viscera should be presented for official
post-mortem inspection at a game-handling establishment.
However, to preserve certain hunting traditions without
prejudicing food safety,
it is appropriate to provide for
training for hunters who place wild game on the market
for human consumption. This should enable hunters to
undertake an initial examination of wild game on the
spot.
is not necessary to
require trained hunters to deliver all viscera to the game-
handling establishment for post-mortem examination,
if
they carry out this initial examination and identify no
anomalies or hazards. However, Member States should
be allowed to establish stricter rules within their territories
to take account of specific risks.

In these circumstances,

it

for

implying that,

adoption of new requirements

(23) This Regulation should establish criteria for raw milk
pending the
its
placing on the market. These criteria should be trigger
values,
in the event of any overshooting,
food business operators are to take corrective action and
to notify the competent authority. The criteria should not
be maximum figures beyond which raw milk cannot be
placed on the market. This implies that, in certain circum-
stances, raw milk not fully meeting the criteria can safely
be used for human consumption, if appropriate measures
are taken. As regards raw milk and raw cream intended for
it is appropriate to enable
direct human consumption,
each Member State to maintain or establish appropriate
health measures
the
objectives of this Regulation on its territory.

the achievement of

to ensure

(24) It is appropriate for the criterion for raw milk used to
manufacture dairy products to be three times as high as
the criterion for raw milk collected from the farm. The
criterion for milk used to manufacture processed dairy
products is an absolute value, whereas for raw milk
collected from the farm it
is an average. Compliance
with the temperature requirements laid down in this Regu-
lation will not halt all bacterial growth during transport
and storage.

(26) In addition, the rules of this Regulation on eggs replace
those of Council Decision 94/371/EC of 20 June 1994
laying down specific public health conditions for the
putting on the market of certain types of eggs (2), which
the repeal of Annex II to Council Directive 92/118/EEC (3)
renders void.

(27) Scientific advice should underpin Community legislation
on food hygiene. To this end, the European Food Safety
Authority should be consulted whenever necessary.

(28) To take account of technical and scientific progress, close
and effective cooperation should be ensured between the
Commission and the Member States within the Standing
Committee on the Food Chain and Animal Health.

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

the new rules,

(30) The measures necessary for the implementation of this
Regulation should be
adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (4),

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1.
This Regulation lays down specific rules on the hygiene
of food of animal origin for food business operators. These
laid down by Regulation (EC)
rules
No . . ./2004 (5). They shall
apply to unprocessed and
processed products of animal origin.

supplement

those

(25) The present recasting means that the existing hygiene rules
can be repealed. Directive 2004/. . ./EC of the European
Parliament and of the Council of . . . repealing certain
Directives on food hygiene and health conditions for the
production and placing on the market of certain products
of animal origin intended for human consumption (1)
achieves this.

(1) See page 131 of this Official Journal.

(2) OJ L 168, 2.7.1994, p. 34.
(3) 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/EEC (OJ L 62, 15.3.1993, p. 49). Directive as last
amended by Commission Decision 2003/42/EC (OJ L 13,
18.1.2003, p. 24).

(4) OJ L 184, 17.7.1999, p. 23.
(5) See page 1 of this Official Journal.

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Unless expressly indicated to the contrary, this Regulation
2.
shall not apply to food containing both products of plant
origin and processed products of animal origin. However,
processed products of animal origin used to prepare such
food shall be obtained and handled in accordance with the
requirements of this Regulation.

6.

This Regulation shall apply without prejudice to:

(a) relevant animal and public health rules,

including more
stringent rules laid down for the prevention, control and
eradication of certain transmissible spongiform encepha-
lopathies;

3.

This Regulation shall not apply in relation to:

(a) primary production for private domestic use;

(b) the domestic preparation, handling or storage of food for

private domestic consumption;

(c) the direct supply, by the producer, of small quantities of
primary products to the final consumer or to local retail
establishments directly supplying the final consumer;

(b) animal welfare requirements; and

(c) requirements concerning the identification of animals and

the traceability of products of animal origin.

Article 2

Definitions

The following definitions shall apply for the purposes of this
Regulation:

(d) the direct supply, by the producer, of small quantities of
meat
from poultry and lagomorphs slaughtered on the
farm to the final consumer or to local retail establishments
directly supplying such meat to the final consumer as fresh
meat;

1) the definitions laid down in Regulation (EC) No 178/2002;

2) the definitions laid down in Regulation (EC) No . . ./2004;

(e) hunters who supply small quantities of wild game or wild
game meat directly to the final consumer or to local retail
establishments directly supplying the final consumer.

3) the definitions laid down in Annex I; and

4) any technical definitions contained in Annexes II and III.

4. Member States shall establish, under national law, rules
governing the activities and persons referred to in paragraph
the
shall
3(c),
achievement of the objectives of this Regulation.

(d) and (e). Such national

ensure

rules

5. (a) Unless expressly indicated to the contrary, this Regu-

lation shall not apply to retail.

(b) However,

this Regulation shall apply to retail when
operations are carried out with a view to the supply
of
food of animal origin to another establishment,
unless:

(i) the operations consist only of storage or transport,
in which case the specific temperature requirements
laid down in Annex III shall nevertheless apply; or

(ii) the supply of food of animal origin from the retail
establishment is to other retail establishments only
and, in accordance with national law, is a marginal,
localised and restricted activity.

CHAPTER II

FOOD BUSINESS OPERATORS' OBLIGATIONS

Article 3

General obligations

Food business operators shall comply with the relevant

1.
provisions of Annexes II and III.

Food business operators shall not use any substance other
2.
than potable water — or, when Regulation (EC) No . . ./2004
or this Regulation permits its use, clean water — to remove
surface contamination from products of animal origin, unless
use of the substance has been approved in accordance with the
procedure referred to in Article 12(2). Food business operators
shall also comply with any conditions for use that may be
adopted under the same procedure. The use of an approved
substance shall not affect the food business operator's duty to
comply with the requirements of this Regulation.

Article 4

Registration and approval of establishments

(c) Member States may adopt national measures to apply
the requirements of
this Regulation to retail estab-
lishments situated on their territory to which it would
not apply pursuant to subparagraphs (a) or (b).

1.
Food business operators shall place products of animal
origin manufactured in the Community on the market only if
they have been prepared and handled exclusively in estab-
lishments:

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(a) that meet

the relevant requirements of Regulation (EC)
No . . ./2004, those of Annexes II and III of this Regulation
and other relevant requirements of food law; and

Article 5

Health and identification marking

(b) that

the competent authority has registered or, where

required in accordance with paragraph 2, approved.

1.
Food business operators shall not place on the market a
product of animal origin handled in an establishment subject to
approval in accordance with Article 4(2) unless it has either:

2. Without prejudice to Article 6(3) of Regulation (EC)
No . . ./2004, establishments handling those products of
animal origin for which Annex III
to this Regulation lays
down requirements shall not operate unless the competent
authority has approved them in accordance with paragraph 3
of this Article, with the exception of establishments carrying
out only:

(a) primary production;

(b) transport operations;

(c) the

storage of products not
controlled storage conditions; or

requiring

temperature-

(d) retail operations other than those to which this Regulation

applies pursuant to Article 1(5)(b).

3.
An establishment subject to approval in accordance with
paragraph 2 shall not operate unless the competent authority
has, in accordance with Regulation (EC) No . . ./2004 of the
European Parliament and of the Council of . . .
laying down
the organisation of official controls on
specific rules for
products of animal origin intended for human consumption (1):

(a) granted the establishment approval to operate following an

on-site visit; or

(b) provided the establishment with conditional approval.

shall

Food business operators

cooperate with the
4.
in accordance with Regulation (EC)
competent authorities
No . . ./2004 (1).
food business operators shall
ensure
the
to operate
competent authority withdraws its approval or, in the case of
conditional approval,
full
approval.

In particular,
an establishment

fails to prolong it or

to grant

ceases

that

if

from
This Article shall not prevent an establishment
5.
placing food on the market between the date of application
of this Regulation and the first subsequent inspection by the
competent authority, if the establishment:

(a)

is subject to approval in accordance with paragraph 2 and
placed products of animal origin on the market
in
accordance with Community legislation immediately prior
to the application of this Regulation; or

(b) is of a type in respect of which there was no requirement
for approval before the application of this Regulation.

(1) See page 82 of this Official Journal.

(a) a health mark applied in accordance with Regulation (EC)

No . . ./2004 (1); or

(b) when that Regulation does not provide for the application
of a health mark, an identification mark applied in
accordance with Annex II, Section I, of this Regulation.

Food business operators may apply an identification mark
2.
to a product of animal origin only if the product has been
manufactured in accordance with this Regulation in estab-
lishments meeting the requirements of Article 4.

3.
Food business operators may not remove a health mark
applied in accordance with Regulation (EC) No . . ./2004 (1)
from meat unless they cut or process it or work upon it in
another manner.

Article 6

Products of animal origin from outside the Community

Food business operators importing products of animal
importation

1.
origin from third countries shall ensure that
takes place only if:

(a) the third country of dispatch appears on a list, drawn up in
accordance with Article
(EC)
No . . ./2004 (1), of third countries from which imports of
that product are permitted;

Regulation

11

of

(b)

(i) the

establishment

from which that product was
and in which it was obtained or
dispatched,
prepared, appears on a list, drawn up in accordance
with Article 12 of Regulation (EC) No . . ./2004 (1), of
establishments from which imports of that product are
permitted, when applicable,

(ii) in the case of fresh meat, minced meat, meat pre-
parations, meat products and MSM, the product was
manufactured from meat obtained in slaughterhouses
and cutting plants appearing on lists drawn up and
updated in accordance with Article 12 of Regulation
(EC) No . . ./2004 (1) or in approved Community estab-
lishments, and

(iii) in the case of

live bivalve molluscs, echinoderms,
tunicates and marine gastropods, the production area
appears on a list drawn up in accordance with Article
13 of that Regulation, when applicable;

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(c) the product satisfies:

(i) the requirements of

including the
requirements of Article 5 on health and identification
marking;

this Regulation,

CHAPTER III

TRADE

Article 7

Documents

(ii) the requirements of Regulation (EC) No . . ./2004 (1);

and

1. When required in accordance with Annex II or III, food
business operators
shall ensure that certificates or other
documents accompany consignments of products of animal
origin.

(iii) any import conditions laid down in accordance with
Community legislation governing import controls for
products of animal origin, and

In accordance with the procedure referred to in Article

2.
12(2):

(d) the

requirements of Article 14 of Regulation (EC)
No . . ./2004 (2) concerning certificates and documents are
satisfied, when applicable.

(a) model documents may be established; and

(b) provision may be made

for

the use of

electronic

documents.

By way of derogation from paragraph 1, the importation
2.
of fishery products may also take place in accordance with the
special provisions laid down in Article 15 of Regulation (EC)
No . . ./2004 (2).

Food business operators importing products of animal

3.
origin shall ensure that:

(a) products are made available for control upon importation

in accordance with Directive 97/78/EC (3);

(b) importation complies with the requirements of Directive

2002/99/EC (4); and

(c) operations under
importation are
requirements of Annex III.

their

carried out

control

that

take place after
in accordance with the

4.
Food business operators importing food containing both
products of plant origin and processed products of animal
origin shall ensure that
the processed products of animal
origin contained in such food satisfy the requirements of
paragraphs 1 to 3. They must be able to demonstrate that
they have done so [for example, through appropriate docu-
mentation or certification, which need not be in the format
specified in paragraph 1(d)].

(1) See page 1 of this Official Journal.
(2) See page 82 of this Official Journal.
(3) Directive 97/78/EC of 18 December 1997 laying down the prin-
ciples governing the organisation of veterinary checks on products
entering the Community from third countries (OJ L 24, 30.1.1998,
p. 9).

(4) Council Directive 2002/99/EC of 16 December 2002 laying down
the animal health rules governing the production, processing,
distribution and introduction of products of animal origin for
human consumption (OJ L 18, 23.1.2003, p. 11).

Article 8

Special guarantees

1.
Food business operators intending to place the following
food of animal origin on the market in Sweden or Finland shall
comply with the rules set out in paragraph 2 in respect of
salmonella:

(a) meat from bovine and porcine animals, including minced

meat but excluding meat preparations and MSM;

(b) meat from poultry of the following species: domestic fowl,
including minced

turkeys, guinea-fowl, ducks and geese,
meat but excluding meat preparations and MSM; and

(c) eggs.

2. (a) In the case of meat from bovine and porcine animals
and meat from poultry, samples of consignments shall
have been taken in the dispatching establishment and
been subjected to a microbiological test with negative
results in accordance with Community legislation.

(b) In the case of eggs, packing centres shall provide a
guarantee that consignments originate from flocks that
have been subjected to a microbiological
test with
negative results in accordance with Community legis-
lation.

(c) In the case of meat from bovine and porcine animals,
the test provided for in subparagraph (a) need not be
carried out
for consignments intended for an estab-
lishment for the purposes of pasteurisation, sterilisation
or treatment having a similar effect. In the case of eggs,
the test provided for in subparagraph (b) need not be
carried out for consignments intended for the manu-
facture of processed products by a process that guaran-
tees the elimination of salmonella.

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that

(d) The tests provided for in subparagraphs (a) and (b) need
not be carried out for foodstuffs originating in an estab-
to a control programme
lishment
recognised,
the food of animal origin
concerned and in accordance with the procedure
referred to in Article 12(2), as equivalent
to that
approved for Sweden and Finland.

subject
in respect of

is

(e) In the case of meat from bovine and porcine animals
and meat from poultry, a trade document or certificate
conforming to a model
laid down by Community
legislation shall accompany the food and state that:

(i) the checks referred to in subparagraph (a) have been

carried out with negative results; or

(ii) the meat

is intended for one of

the purposes

referred to in subparagraph (c); or

(iii) the meat comes from an establishment covered by

subparagraph (d).

(f)

In the case of eggs, a certificate stating that the tests
referred to in subparagraph (b) have been carried out
with negative results, or that the eggs are destined to be
used in the manner referred to in subparagraph (c), must
accompany consignments.

In accordance with the procedure referred to in Article

3.
12(2):

(a) the requirements of paragraphs 1 and 2 may be updated to
take account in particular of changes to Member States'
control programmes or the adoption of microbiological
(EC)
criteria
No . . ./2004 (1); and

accordance

Regulation

with

in

CHAPTER IV

FINAL PROVISIONS

Article 9

Implementing measures and transitional measures

Implementing measures and transitional arrangements may be
laid down in accordance with the procedure referred to in
Article 12(2).

Article 10

Amendment and adaptation of Annexes II and III

1.
Annexes II and III may be repealed, amended, adapted or
supplemented, in accordance with the procedure referred to in
Article 12(2), to take account of:

(a) the development of guides to good practice;

(b) the

experience

implementation of
HACCP-based systems pursuant to Article 5 of Regulation
(EC) No . . ./2004 (1);

gained from the

(c)

technological developments;

(d) changes in patterns of consumption;

(e) scientific advice, particularly new risk assessments;

(f)

the setting of food safety targets.

2.
Exemptions from Annex II and III may be granted in
accordance with the procedure referred to in Article 12(2),
provided that
the
objectives of this Regulation.

the achievement of

they do not affect

3. Member States may, without compromising achievement
of the objectives of this Regulation, adopt, in accordance with
paragraphs
the
4 to 8,
requirements laid down in Annex III.

national measures

adapting

(b) the rules laid down in paragraph 2 in respect of any of the
foodstuffs referred to in paragraph 1 may be extended, in
whole or in part, to any Member State, or any region of a
Member State, that has a control programme recognised as
equivalent to that approved for Sweden and Finland in
respect of the food of animal origin concerned.

4. (a) The national measures referred to in paragraph 3 shall

have the aim of:

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

any of
distribution of food; or

For the purposes of

4.
‘control programme’
means a control programme approved in accordance with
Regulation (EC) No . . ./2004 (2).

this Article,

(ii) accommodating

the needs of

that are subject

food businesses
to special

situated in regions
geographic constraints.

(1) See page 1 of this Official Journal.
(2) Regulation on food-borne zoonotic agents (see recital 17).

(b) In other cases, they shall apply only to the construction,

layout and equipment of establishments.

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

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

(b) describe the foodstuffs and establishments concerned;

(c) explain the reasons for the adaptation,

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

(d) give any other relevant information.

6.
The other Member States shall have three months from
the receipt of a notification referred to in paragraph 5 to send
written comments to the Commission. In the case of adap-
tations arising from paragraph 4(b), this period shall, at the
request of any Member State, be extended to four months. The
Commission may, and when it receives written comments from
one or more Member States shall, consult Member States
within the committee referred to in Article 12(1). The
Commission may decide,
in accordance with the procedure
referred to in Article 12(2), whether the envisaged measures
may be implemented, subject,
to appropriate
the Commission may
appropriate,
amendments. Where
propose general measures in accordance with paragraph 1 or
2 of this Article.

if necessary,

A Member State may adopt national measures adapting

7.
the requirements of Annex III only:

(a)

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

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

adoption of

to propose

the

(c)

in accordance with paragraph 8.

Annex III, Section IX, as regards plate count and somatic
cell count of the manufacture of cheeses with an ageing or
ripening period of at least 60 days, and dairy products
obtained in connection with the manufacture of such
the
cheeses, provided that
achievement of the objectives of this Regulation.

this does not prejudice

Article 11

Specific decisions

implementing measures may be

Without prejudice to the generality of Article 9 and Article
10(1),
laid down, or
amendments to Annex II or III adopted, in accordance with
the procedure referred to in Article 12(2):

1) to lay down rules for the transport of meat while it is

warm;

2) to specify, in respect of MSM, which calcium content is

not significantly higher than that of minced meat;

3) to lay down other treatments that may be applied in a
to live bivalve molluscs from
that have not been

processing establishment
class B or C production areas
submitted to purification or relaying;

4) to specify
biotoxins;

recognised

testing methods

for marine

5) to lay down additional health standards for live bivalve
molluscs in cooperation with the relevant Community
Reference Laboratory, including:

(a)

limit values and analysis methods for other marine
biotoxins;

(b) virus testing procedures and virological standards; and

(c) sampling plans

and analytical
and the methods
tolerances to be applied to check compliance with
the health standards;

6) to lay down health standards or checks, where there is
scientific evidence indicating that they are necessary to
protect public health;

A Member State may, of its own initiative and subject to
the Treaty, maintain or establish

8.
the general provisions of
national rules:

7) to extend Annex III, Section VII, Chapter IX, to live bivalve

molluscs other than pectinidae;

(a) prohibiting or restricting the placing on the market within
its territory of raw milk or raw cream intended for direct
human consumption; or

(b) permitting the use, with the authorisation of the competent
authority, of raw milk not meeting the criteria laid down in

8) to specify criteria for determining when epidemiological
data indicate that a fishing ground does not present a
health hazard with regard to the presence of parasites
and, consequently, for determining when the competent
authority may authorise food business operators not to
freeze fishery products in accordance with Annex III,
Section VIII, Chapter III, Part D;

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9) to lay down freshness criteria and limits with regard to
histamine and total volatile nitrogen for fisheries products;

10) to permit the use for the manufacture of certain dairy
products of raw milk not meeting the criteria laid down
in Annex III, Section IX, as regards its plate count and
somatic cell count;

11) without prejudice to Directive 96/23/EC (1),

to fix a
maximum permitted value for the combined total of
residues of antibiotic substances in raw milk; and

12) to approve equivalent processes for the production of

gelatine or collagen.

Article 12

Committee procedure

The Commission shall be assisted by the Standing

1.
Committee on the Food Chain and Animal Health.

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

The period provided for
1999/468/EC shall be set at three months.

in Article 5(6) of Decision

3.

The Committee shall adopt its rules of procedure.

Article 13

lation that could have a significant impact on public health
and,
in particular, before proposing to extend Annex III,
Section III, to other animal species.

Article 14

Report to the European Parliament and to the Council

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

The Commission shall,

2.
report with relevant proposals.

if appropriate, accompany the

Article 15

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

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

(a) Regulation (EC) No . . ./2004 (2);

(b) Regulation (EC) No . . ./2004 (3); and

Consultation of the European Food Safety Authority

(c) Directive 2004/. . ./EC (4).

The Commission shall consult
the European Food Safety
Authority on any matter falling within the scope of this Regu-

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

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

Done at . . .

For the European Parliament

The President

For the Council

The President

(1) Council Directive 96/23/EC of 29 April 1996 on measures to
monitor certain substances and residues thereof
in live animals
and animal products (OJ L 125, 23.5.1996, p. 10). Directive as
amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003,
p. 1).

(*) Five years after the entry into force of this Regulation.
(2) See page 1 of this Official Journal.
(3) Regulation referred to in Article 4(3).
(4) Directive referred to in recital 25.

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ANNEX I

DEFINITIONS

For the purpose of this Regulation:

1.

MEAT

1.1.

‘Meat’ means edible parts of the animals referred to in points 1.2 to 1.8, including blood.

1.2.

‘Domestic ungulates’ means domestic bovine (including Bubalus and Bison species), porcine, ovine and caprine
animals, and domestic solipeds.

1.3.

‘Poultry’ means farmed birds,
domestic animals, with the exception of ratites.

including birds that are not considered as domestic but which are farmed as

1.4.

‘Lagomorphs’ means rabbits, hares and rodents.

1.5.

‘Wild game’ means:

— wild ungulates and lagomorphs, as well as other land mammals that are hunted for human consumption and
are considered to be wild game under the applicable law in the Member State concerned, including mammals
living in enclosed territory under conditions of freedom similar to those of wild game; and

— wild birds that are hunted for human consumption.

1.6.

‘Farmed game’ means farmed ratites and farmed land mammals other than those referred to in point 1.2.

1.7.

‘Small wild game’ means wild game birds and lagomorphs living freely in the wild.

1.8.

‘Large wild game’ means wild land mammals living freely in the wild that do not fall within the definition of small
wild game.

1.9.

‘Carcase’ means the body of an animal after slaughter and dressing.

1.10.

‘Fresh meat’ means meat that has not undergone any preserving process other than chilling, freezing or quick-
freezing, including meat that is vacuum-wrapped or wrapped in a controlled atmosphere.

1.11.

‘Offal’ means fresh meat other than that of the carcase, including viscera and blood.

1.12.

‘Viscera’ means the organs of the thoracic, abdominal and pelvic cavities, as well as the trachea and oesophagus
and, in birds, the crop.

1.13.

‘Minced meat’ means boned meat that has been minced into fragments and contains less than 1 % salt.

1.14.

‘Mechanically separated meat’ or ‘MSM’ means the product obtained by removing meat from flesh-bearing bones
after boning or from poultry carcases, using mechanical means resulting in the loss or modification of the muscle
fibre structure.

1.15.

‘Meat preparations’ means fresh meat,
including meat that has been reduced to fragments, which has had
foodstuffs, seasonings or additives added to it or which has undergone processes insufficient to modify the
internal muscle fibre structure of the meat and thus to eliminate the characteristics of fresh meat.

1.16.

‘Slaughterhouse’ means an establishment used for slaughtering and dressing animals, the meat of which is
intended for human consumption.

1.17.

‘Cutting plant’ means an establishment used for boning and/or cutting up meat.

1.18.

‘Game-handling establishment’ means any establishment in which game and game meat obtained after hunting are
prepared for placing on the market.

2.

LIVE BIVALVE MOLLUSCS

2.1.

‘Bivalve molluscs’ means filter-feeding lamellibranch molluscs.

2.2.

‘Marine biotoxins’ means poisonous substances accumulated by bivalve molluscs,
feeding on plankton containing toxins.

in particular as a result of

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2.3.

‘Conditioning’ means the storage of live bivalve molluscs coming from class A production areas, purification
centres or dispatch centres in tanks or any other installation containing clean seawater, or in natural sites, to
remove sand, mud or slime, to preserve or to improve organoleptic qualities and to ensure that they are in a good
state of vitality before wrapping or packaging.

2.4.

‘Gatherer’ means 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.

2.5.

‘Production area’ means any sea, estuarine or lagoon area, containing either natural beds of bivalve molluscs or
sites used for the cultivation of bivalve molluscs, and from which live bivalve molluscs are taken.

2.6.

‘Relaying area’ means any sea, estuarine or lagoon area 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.

2.7.

‘Dispatch centre’ means any on-shore or off-shore establishment for the reception, conditioning, washing, cleaning,
grading, wrapping and packaging of live bivalve molluscs fit for human consumption.

2.8.

‘Purification centre’ means an establishment with tanks fed by clean seawater in which live bivalve molluscs are
placed for the time necessary to reduce contamination to make them fit for human consumption.

2.9.

‘Relaying’ means the transfer of live bivalve molluscs to sea, lagoon or estuarine areas for the time necessary to
reduce contamination to make them fit for human consumption. This does not include the specific operation of
transferring bivalve molluscs to areas more suitable for further growth or fattening.

3.

FISHERY PRODUCTS

3.1.

‘Fishery products’ means all seawater or freshwater animals (except for live bivalve molluscs, live echinoderms, live
tunicates and live marine gastropods, and all mammals, reptiles and frogs) whether wild or farmed and including
all edible forms, parts and products of such animals.

3.2.

‘Factory vessel’ means any vessel on board which fishery products undergo one or more of the following
operations followed by wrapping or packaging and, if necessary, chilling or freezing: filleting, slicing, skinning,
shelling, shucking, mincing or processing.

3.3.

‘Freezer vessel’ means any vessel on board which freezing of fishery products is carried out, where appropriate
after preparatory work such as bleeding, heading, gutting and removal of fins and, where necessary, followed by
wrapping or packaging.

3.4.

‘Mechanically separated fishery product’ means any product obtained by removing flesh from fishery products
using mechanical means resulting in the loss or modification of the flesh structure.

3.5.

‘Fresh fishery products’ means unprocessed fishery products, whether whole or prepared,
including products
packaged under vacuum or in a modified atmosphere, that have not undergone any treatment to ensure preser-
vation other than chilling.

3.6.

‘Prepared fishery products’ means unprocessed fishery products that have undergone an operation affecting their
anatomical wholeness, such as gutting, heading, slicing, filleting, and chopping.

4.

MILK

4.1.

‘Raw milk’ means milk produced by the secretion of the mammary gland of farmed animals that has not been
heated to more than 40 °C or undergone any treatment that has an equivalent effect.

4.2.

‘Milk production holding’ means an establishment where one or more farmed animals are kept to produce milk
with a view to placing it on the market as food.

5.

EGGS

5.1.

‘Eggs’ means eggs in shell — other than broken, incubated or cooked eggs — that are produced by farmed birds
and are fit for direct human consumption or for the preparation of egg products.

5.2.

‘Liquid egg’ means unprocessed egg contents after removal of the shell.

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5.3.

‘Cracked eggs’ means eggs with damaged shell and intact membranes.

5.4.

‘Packing centre’ means an establishment where eggs are graded by quality and weight.

6.

FROGS' LEGS AND SNAILS

6.1.

‘Frogs' legs’ means the posterior part of the body divided by a transverse cut behind the front limbs, eviscerated
and skinned, of the species RNA (family Ranidae).

6.2.

‘Snails’ means terrestrial gastropods of the species Helix pomatia Linné, Helix aspersa Muller, Helix lucorum and
species of the family Achatinidae.

7.

PROCESSED PRODUCTS

7.1.

‘Meat products’ means processed products resulting from the processing of meat or from the further processing of
such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh
meat.

7.2.

‘Dairy products’ means processed products resulting from the processing of raw milk or from the further
processing of such processed products.

7.3.

‘Egg products’ means processed products resulting from the processing of eggs, or of various components or
mixtures of eggs, or from the further processing of such processed products.

7.4.

‘Processed fishery products’ means processed products resulting from the processing of fishery products or from
the further processing of such processed products.

7.5.

‘Rendered animal
consumption.

fat’ means fat derived from rendering meat,

including bones, and intended for human

7.6.

‘Greaves’ means the protein-containing residue of rendering, after partial separation of fat and water.

7.7.

‘Gelatine’ means 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.

7.8.

‘Collagen’ means the protein-based product derived from animal bones, hides, skins and tendons manufactured in
accordance with the relevant requirements of this Regulation.

7.9.

‘Treated stomachs, bladders and intestines’ means stomachs, bladders and intestines that have been submitted to a
treatment such as salting, heating or drying after they have been obtained and after cleaning.

8.

OTHER DEFINITIONS

8.1.

‘Products of animal origin’ means:

— food of animal origin, including honey and blood;

— live bivalve molluscs,
consumption; and

live echinoderms,

live tunicates and live marine gastropods intended for human

— other animals destined to be prepared with a view to being supplied live to the final consumer.

8.2.

‘Wholesale market’ means a food business that includes several separate units which share common installations
and sections where foodstuffs are sold to food business operators.

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REQUIREMENTS CONCERNING SEVERAL PRODUCTS OF ANIMAL ORIGIN

ANNEX II

SECTION I: IDENTIFICATION MARKING

When required in accordance with Article 5 or 6, and subject to the provisions of Annex III, food business operators
must ensure that products of animal origin have an identification mark applied in compliance with the following
provisions.

A. APPLICATION OF THE IDENTIFICATION MARK

1. The identification mark must be applied before the product leaves the establishment.

2. However, a new mark need not be applied to a product unless its packaging and/or wrapping is removed or it is
further processed in another establishment, in which case the new mark must indicate the approval number of the
establishment where these operations take place.

3. An identification mark is not necessary for eggs in respect of which Regulation (EC) No 1907/90 (1) lays down

requirements concerning labelling or marking.

4. Food business operators must,

in accordance with Article 18 of Regulation (EC) No 178/2002, have in place
systems and procedures to identify food business operators from whom they have received, and to whom they have
delivered, products of animal origin.

B. FORM OF THE IDENTIFICATION MARK

5. The mark must be legible and indelible, and the characters easily decipherable. It must be clearly displayed for the

competent authorities.

6. The mark must indicate the name of the country in which the establishment is located, which may be written out

in full or shown as a two-letter code in accordance with the relevant ISO standard.

In the case of Member States, however, these codes are AT, BE, DE, DK, ES, FI, FR, GR, IE, IT, LU, NL, PT, SE and
UK.

Food business operators may continue to use stocks and equipment that they ordered before the entry into force of
this Regulation until they are exhausted or require replacement.

7. The mark must indicate the approval number of the establishment. If an establishment manufactures both food to
which this Regulation applies and food to which it does not, the food business operator may apply the same
identification mark to both types of food.

8. When applied in an establishment located within the Community, the mark must be oval in shape and include the

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

C. METHOD OF MARKING

9. The 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 mark may also be an irremovable tag made of a resistant material.

10. In the case of packaging containing cut meat or offal, the mark must be applied to a label fixed to the packaging, or
printed on the packaging, in such a way that it is destroyed when the packaging is opened. This is not necessary,
however,
if the process of opening destroys the packaging. When wrapping provides the same protection as
packaging, the label may be affixed to the wrapping.

11. For products of animal origin that are placed in transport containers or large packages and are intended for further
handling, processing, wrapping or packaging in another establishment, the mark may be applied to the external
surface of the container or packaging.

12. In the case of liquid, granulate and powdered products of animal origin carried in bulk, and fishery products carried
in bulk, an identification mark is not necessary if accompanying documentation contains the information specified
in paragraphs 6, 7 and, where appropriate, 8.

(1) Council Regulation (EEC) No 1907/90 of 26 June 1990 on certain marketing standards for eggs (OJ L 173, 6.7.1990, p. 5).

Regulation as last amended by Regulation (EC) No 5/2001 (OJ L 2, 5.1.2001, p. 1).

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13. When products of animal origin are placed in a package destined for direct supply to the final consumer, it is

sufficient to apply the mark to the exterior of that package only.

14. When the mark is applied directly to products of animal origin, the colours used must be authorised in accordance

with Community rules on the use of colouring substances in foodstuffs.

SECTION II: OBJECTIVES OF HACCP-BASED PROCEDURES

1. Food business operators operating slaughterhouses must ensure that the procedures that they have put in place in
accordance with the general requirements of Article 5 of Regulation (EC) No . . ./2004 (1) meet the requirements that
the hazard analysis shows to be necessary and the specific requirements listed in paragraph 2.

2. The procedures must guarantee that each animal or, where appropriate, each lot of animals accepted onto the

slaughterhouse premises:

(a)

is properly identified;

(b) is accompanied by the relevant information from the holding of provenance referred to in Section III;

(c) does not come from a holding or an area subject to a movement prohibition or other restriction for reasons of

animal or public health, except when the competent authority so permits;

(d) is clean;

(e)

is healthy, as far as the food business operator can judge; and

(f)

is in a satisfactory state as regards welfare on arrival at the slaughterhouse.

3. In the event of failure to comply with any of the requirements listed under paragraph 2, the food business operator

must notify the official veterinarian and take appropriate measures.

SECTION III: FOOD CHAIN INFORMATION

Food business operators operating slaughterhouses must, as appropriate, request, receive, check and act upon food chain
information as set out in this Section in respect of all animals, other than wild game, sent or intended to be sent to the
slaughterhouse.

1. Slaughterhouse operators must not accept animals onto the slaughterhouse premises unless they have requested and
been provided with relevant food safety information contained in the records kept at the holding of provenance in
accordance with Regulation (EC) No . . ./2004.

2. Slaughterhouse operators must be provided with the information no less than 24 hours before the arrival of animals

at the slaughterhouse, except in the circumstances mentioned in point 7.

3. The relevant food safety information referred to in point 1 is to cover, in particular:

(a)

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

(b) the animals' health status;

(c) veterinary medicinal products or other treatments administered to the animals within a relevant period and with
a withdrawal period greater than zero, together with their dates of administration and withdrawal periods;

(d) the occurrence of diseases that may affect the safety of meat;

(e)

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

(1) Regulation on the hygiene of foodstuffs.

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(f)

relevant reports about previous ante- and post-mortem inspections of animals from the same holding of prove-
nance including, in particular, reports from the official veterinarian;

(g) production data, when this might indicate the presence of disease; and

(h) the name and address of the private veterinarian normally attending the holding of provenance.

4. (a) However, it is not necessary for the slaughterhouse operator to be provided with:

(i) the information referred to in point 3(a), (b), (f) and (h), if the operator is already aware of this information

(for example, through a standing arrangement or a quality assurance scheme); or

(ii) the information referred to in point 3(a), (b), (f) and (g), if the producer declares that there is no relevant

information to report.

(b) The information need not be provided as a verbatim extract from the records of the holding of provenance. It
may be provided through electronic data exchange or in the form of a standardised declaration signed by the
producer.

5. Food business operators deciding to accept animals onto the slaughterhouse premises after evaluating the relevant
food chain information must make it available to the official veterinarian without delay and, except in the circum-
stances mentioned in point 7, no less than 24 hours before the arrival of the animal or lot. The food business
operator must notify the official veterinarian of any information that gives rise to health concerns before ante-mortem
inspection of the animal concerned.

6. If any animal arrives at the slaughterhouse without food chain information, the operator must immediately notify the

official veterinarian. Slaughter of the animal may not take place until the official veterinarian so permits.

7. If the competent authority so permits, food chain information may accompany the animals to which it relates to the

slaughterhouse, rather than arriving at least 24 hours in advance, in the case of:

(a) porcine animals, poultry or farmed game that have undergone ante-mortem inspection at the holding of prove-
nance, if a certificate that the veterinarian has signed stating that he or she examined the animals at the holding
and found them to be healthy accompanies them;

(b) domestic solipeds;

(c) animals that have undergone emergency slaughter, if a declaration, that the veterinarian has signed recording the

favourable outcome of the ante-mortem inspection accompanies them; and

(d) animals that are not delivered directly from the holding of provenance to the slaughterhouse.

Slaughterhouse operators must evaluate the relevant information. If they accept the animals for slaughter, they must
give the documents mentioned in subparagraphs (a) and (c) to the official veterinarian. Slaughter or dressing of the
animals may not take place until the official veterinarian so permits.

8. Food business operators must check passports accompanying domestic solipeds to ensure that the animal is intended
for slaughter for human consumption. If they accept the animal for slaughter, they must give the passport to the
official veterinarian.

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ANNEX III

SPECIFIC REQUIREMENTS

SECTION I: MEAT OF DOMESTIC UNGULATES

CHAPTER I: TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE

Food business operators transporting live animals to slaughterhouses must ensure compliance with the following
requirements.

1. During collection and transport, animals must be handled carefully without causing unnecessary distress.

2. Animals showing symptoms of disease or originating in herds known to be contaminated with agents of public

health importance may only be transported to the slaughterhouse when the competent authority so permits.

CHAPTER II: REQUIREMENTS FOR SLAUGHTERHOUSES

Food business operators must ensure that the construction, layout and equipment of slaughterhouses in which domestic
ungulates are slaughtered meet the following requirements.

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

(b) They must also have separate lockable facilities 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, unless the competent
authority considers that such facilities are unnecessary.

(c) The size of the lairage facilities must ensure that the welfare of the animals is respected. Their layout must

facilitate ante-mortem inspections, including the identification of the animals or groups of animals.

2. To avoid contaminating meat, they must:

(a) have a sufficient number of rooms, appropriate to the operations being carried out;

(b) have a separate room for the emptying and cleaning of stomachs and intestines, unless the competent authority
authorises the separation in time of these operations within a specific slaughterhouse on a case-by-case basis;

(c) ensure separation in space or time of the following operations:

(i) stunning and bleeding;

(ii) in the case of porcine animals, scalding, depilation, scraping and singeing;

(iii) evisceration and further dressing;

(iv) handling clean guts and tripe;

(v) preparation and cleaning of other offal, particularly the handling of skinned heads if it does not take place at

the slaughter line;

(vi) packaging offal; and

(vii) dispatching meat;

(d) have installations that prevent contact between the meat and the floors, walls and fixtures; and

(e) have slaughter lines (where operated) that are designed to allow constant progress of the slaughter process and to
avoid cross-contamination between the different parts of the slaughter line. Where more than one slaughter line
is operated in the same premises, there must be adequate separation of the lines to prevent cross-contamination.

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3. They must have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative

system having an equivalent effect.

4. The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to

prevent the spread of contamination.

5. There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the

storage of meat declared unfit for human consumption.

6. There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of means of
transport for livestock. However, slaughterhouses need not have these places and facilities if the competent authority
so permits and official authorised places and facilities exist nearby.

7. They must have lockable facilities 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.

8. If manure or digestive tract content is stored in the slaughterhouse, there must be a special area or place for that

purpose.

9. They must have an adequately equipped lockable facility or, where needed, room for the exclusive use of the

veterinary service.

CHAPTER III: REQUIREMENTS FOR CUTTING PLANTS

Food business operators must ensure that cutting plants handling meat of domestic ungulates:

1. are constructed so as to avoid contamination of meat, in particular by:

(a) allowing constant progress of the operations; or

(b) ensuring separation between the different production batches;

2. have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a way

that the packaging material and the manner of storage cannot be a source of contamination for the meat;

3. have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V;

4. have equipment for washing hands with taps designed to prevent the spread of contamination, for use by staff

engaged in handling exposed meat; and

5. have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an

equivalent effect.

CHAPTER IV: SLAUGHTER HYGIENE

Food business operators operating slaughterhouses in which domestic ungulates are slaughtered must ensure compliance
with the following requirements.

1. After arrival in the slaughterhouse, the slaughter of the animals must not be unduly delayed. However, where

required for welfare reasons, animals must be given a resting period before slaughter.

2. (a) Meat from animals other than those referred to in subparagraphs (b) and (c) must not be used for human

consumption if they die otherwise than by being slaughtered in the slaughterhouse.

(b) Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of:

(i) animals that have undergone emergency slaughter outside the slaughterhouse in accordance with Chapter

VI;

(ii) animals slaughtered at the place of production in accordance with Section III; and

(iii) wild game, in compliance with Section IV, Chapter II.

(c) Meat from animals that undergo slaughter following an accident in a slaughterhouse may be used for human

consumption if, on inspection, no serious lesions other than those due to the accident are found.

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3. The animals or, where appropriate, each batch of animals sent for slaughter must be identified so that their origin

can be traced.

4. Animals must be clean.

5. Slaughterhouse operators must follow the instructions of the veterinarian appointed by the competent authority in
accordance with Regulation (EC) No . . ./2004 (1) to ensure that ante-mortem inspection of every animal to be
slaughtered is carried out under suitable conditions.

6. Animals brought into the slaughter hall must be slaughtered without undue delay.

7. Stunning, bleeding, skinning, evisceration and other dressing must be carried out without undue delay and in a

manner that avoids contaminating the meat. In particular:

(a) the trachea and oesophagus must remain intact during bleeding, except in the case of slaughter according to a

religious custom;

(b) during the removal of hides and fleece:

(i) contact between the outside of the skin and the carcase must be prevented; and

(ii) operators and equipment coming into contact with the outer surface of hides and fleece must not touch the

meat;

(c) measures must be taken to prevent the spillage of digestive tract content during and after evisceration and to

ensure that evisceration is completed as soon as possible after stunning; and

(d) removal of the udder must not result in contamination of the carcase with milk or colostrum.

8. Complete skinning of the carcase and other parts of the body intended for human consumption must be carried
out, except for porcine animals and the heads and feet of ovine and caprine animals and calves. Heads and feet
must be handled so as to avoid contamination of other meat.

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

10. The carcases must not contain visible faecal contamination. Any visible contamination must be removed without

delay by trimming or alternative means having an equivalent effect.

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

12. Slaughterhouse operators must follow the instructions of the competent authority to ensure that post-mortem
inspection of all slaughtered animals is carried out under suitable conditions in accordance with Regulation (EC)
No . . ./2004 (1).

13. Until post-mortem inspection is completed, parts of a slaughtered animal subject to such inspection must:

(a) remain identifiable as belonging to a given carcase; and

(b) come into contact with no other carcase, offal or viscera, including those that have already undergone post-

mortem inspection.

However, provided that it shows no pathological lesion, the penis may be discarded immediately.

14. Both kidneys must be removed from their fatty covering. In the case of bovine and porcine animals, and solipeds,

the peri-renal capsule must also be removed.

15. If the blood or other offal of several animals is collected in the same container before completion of 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.

(1) See page 82 of this Official Journal.

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16. After post-mortem inspection:

(a) the tonsils of bovine animals and solipeds must be removed hygienically;

(b) parts unfit for human consumption must be removed as soon as possible from the clean sector of the

establishment;

(c) meat detained or declared unfit for human consumption and inedible by-products must not come into contact

with meat declared fit for human consumption; and

(d) viscera or parts of viscera remaining in the carcase, except for the kidneys, must be removed entirely and as

soon as possible, unless the competent authority authorises otherwise.

17. After completion of slaughter and post-mortem inspection, the meat must be stored in accordance with the

requirements laid down in Chapter VII.

18. When destined for further handling:

(a) stomachs must be scalded or cleaned;

(b) intestines must be emptied and cleaned; and

(c) heads and feet must be skinned or scalded and depilated.

19. 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 operations carried out on the different species. Separate facilities for the reception and storage of
unskinned carcases of farmed game slaughtered at the farm and for wild game must be available.

20. If the slaughterhouse does not have lockable facilities reserved for the slaughter of sick or suspect animals, the
facilities used to slaughter such animals must be cleaned, washed and disinfected under official supervision before
the slaughter of other animals is resumed.

CHAPTER V: HYGIENE DURING CUTTING AND BONING

Food business operators must ensure that cutting and boning of meat of domestic ungulates takes place in accordance
with the following requirements.

1. Carcases of domestic ungulates may be cut into half-carcases or quarters, and half carcases into no more than three

wholesale cuts, in slaughterhouses. Further cutting and boning must be carried out in a cutting plant.

2. The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food

business operators must ensure in particular that:

(a) meat intended for cutting is brought into the workrooms progressively as needed;

(b) during cutting, boning, trimming, slicing, dicing, wrapping and packaging, the meat is maintained at not more
than 3 °C for offal and 7 °C for other meat, by means of an ambient temperature of not more than 12 °C or an
alternative system having an equivalent effect; and

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

3. However, meat may be boned and cut before it reaches the temperature referred to in point 2(b) in accordance with

Chapter VII, point 3.

4. Meat may also be boned and cut prior to reaching the temperature referred to in point 2(b) when the cutting room is
on the same site as the slaughter premises. In this case, the meat must be transferred to the cutting room either
directly from the slaughter premises or after a waiting period in a chilling or refrigerating room. As soon as it is cut
and, where appropriate, packaged, the meat must be chilled to the temperature referred to in point 2(b).

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CHAPTER VI: EMERGENCY SLAUGHTER OUTSIDE THE SLAUGHTERHOUSE

Food business operators must ensure that meat from domestic ungulates that have undergone emergency slaughter
outside the slaughterhouse may be used for human consumption only if it complies with all the following requirements.

1. An otherwise healthy animal must have suffered an accident that prevented its transport to the slaughterhouse for

welfare reasons.

2. A veterinarian must carry out an ante-mortem inspection of the animal.

3. The slaughtered and bled animal must be transported to the slaughterhouse hygienically and without undue delay.
Removal of the stomach and intestines, but no other dressing, may take place on the spot, under the supervision of
the veterinarian. Any viscera removed must accompany the slaughtered animal to the slaughterhouse and be
identified as belonging to that animal.

4. If more than two hours elapse between slaughter and arrival at the slaughterhouse, the animal must be refrigerated.

Where climatic conditions so permit, active chilling is not necessary.

5. A declaration by the food business operator who reared the animal, stating the identity of the animal and indicating
any veterinary products or other treatments administered to the animal, dates of administration and withdrawal
periods, must accompany the slaughtered animal to the slaughterhouse.

6. A declaration issued by the veterinarian recording the favourable outcome of the ante-mortem inspection, the date and
time of, and reason for, emergency slaughter, and the nature of any treatment administered by the veterinarian to the
animal, must accompany the slaughtered animal to the slaughterhouse.

7. The slaughtered animal must be fit for human consumption following post-mortem inspection carried out in the
slaughterhouse in accordance with Regulation (EC) No . . ./2004 (1), including any additional tests required in the case
of emergency slaughter.

8. Food business operators must follow any instructions that the official veterinarian may give after post-mortem

inspection concerning the use of the meat.

9. Food business operators may not place meat from animals having undergone emergency slaughter on the market
unless it bears a special health mark which cannot be confused either with the health mark provided for in
Regulation (EC) No . . ./2004 (1) or with the identification mark provided for in Annex II, Section I to this Regulation.
Such meat may be placed on the market only in the Member State where slaughter takes place and in accordance
with national law.

CHAPTER VII: STORAGE AND TRANSPORT

Food business operators must ensure that the storage and transport of meat of domestic ungulates takes place in
accordance with the following requirements.

1. (a) Unless other specific provisions provide otherwise, post-mortem inspection must be followed immediately by
chilling in the slaughterhouse to ensure a temperature throughout the meat of not more than 3 °C for offal
and 7 °C for other meat along a chilling curve that ensures a continuous decrease of the temperature. However,
meat may be cut and boned during chilling in accordance with Chapter V, point 4.

(b) During the chilling operations, there must be adequate ventilation to prevent condensation on the surface of the

meat.

2. Meat must attain the temperature specified in point 1 and remain at that temperature during storage.

3. Meat must attain the temperature specified in point 1 before transport, and remain at that temperature during
transport. However, transport may also take place if the competent authority so authorises to enable the production
of specific products, provided that:

(a) such transport takes place in accordance with the requirements that the competent authority specifies in respect

of transport from one given establishment to another; and

(1) See page 82 of this Official Journal.

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(b) the meat leaves the slaughterhouse, or a cutting room on the same site as the slaughter premises, immediately

and transport takes no more than two hours.

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

period before freezing.

5. Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at
different times or in such a way that the packaging material and the manner of storage or transport cannot be a
source of contamination for the meat.

SECTION II: MEAT FROM POULTRY AND LAGOMORPHS

CHAPTER I: TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE

Food business operators transporting live animals to slaughterhouses must ensure compliance with the following
requirements.

1. During collection and transport, animals must be handled carefully without causing unnecessary distress.

2. Animals showing symptoms of disease or originating in flocks known to be contaminated with agents of public-
health importance may only be transported to the slaughterhouse when permitted by the competent authority.

3. Crates for delivering animals to the slaughterhouse and modules, where used, must be made of non-corrodible
material and be easy to clean and disinfect. Immediately after emptying and, if necessary, before re-use, all equipment
used for collecting and delivering live animals must be cleaned, washed and disinfected.

CHAPTER II: REQUIREMENTS FOR SLAUGHTERHOUSES

Food business operators must ensure that the construction, layout and equipment of slaughterhouses in which poultry
or lagomorphs are slaughtered meet the following requirements.

1. They must have a room or covered space for the reception of the animals and for their inspection before slaughter.

2. To avoid contaminating meat, they must:

(a) have a sufficient number of rooms, appropriate to the operations being carried out;

(b) have a separate room for evisceration and further dressing, including the addition of seasonings to whole poultry
carcases, unless the competent authority authorises separation in time of these operations within a specific
slaughterhouse on a case-by-case basis;

(c) ensure separation in space or time of the following operations:

(i) stunning and bleeding;

(ii) plucking or skinning, and any scalding; and

(iii) dispatching meat;

(d) have installations that prevent contact between the meat and the floors, walls and fixtures; and

(e) have slaughter lines (where operated) that are designed to allow a constant progress of the slaughter process and
to avoid cross-contamination between the different parts of the slaughter line. Where more than one slaughter
line is operated in the same premises, there must be adequate separation of the lines to prevent cross-contami-
nation.

3. They must have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative

system having an equivalent effect.

4. The equipment for washing hands used by the staff engaged in handling exposed meat must have taps designed to

prevent the spread of contamination.

5. There must be lockable facilities for the refrigerated storage of detained meat and separate lockable facilities for the

storage of meat declared unfit for human consumption.

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6. There must be a separate place with appropriate facilities for the cleaning, washing and disinfection of:

(a) transport equipment such as crates; and

(b) means of transport.

These places and facilities are not compulsory for (b) if officially authorised places and facilities exist nearby.

7. They must have an adequately equipped lockable facility or, where needed, room for the exclusive use of the

veterinary service.

CHAPTER III: REQUIREMENTS FOR CUTTING PLANTS

1. Food business operators must ensure that cutting plants handling meat from poultry or lagomorphs:

(a) are constructed so as to avoid contamination of meat, in particular by:

(i) allowing constant progress of the operations; or

(ii) ensuring separation between the different production batches;

(b) have rooms for the separate storage of packaged and exposed meat, unless stored at different times or in such a
way that the packaging material and the manner of storage cannot be a source of contamination for the meat;

(c) have cutting rooms equipped to ensure compliance with the requirements laid down in Chapter V;

(d) have equipment for washing hands used by staff handling exposed meat with taps designed to prevent the spread

of contamination; and

(e) have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having

an equivalent effect.

2. If the following operations are undertaken in a cutting plant:

(a) the evisceration of geese and ducks reared for the production of ‘foie gras’, which have been stunned, bled and

plucked on the fattening farm; or

(b) the evisceration of delayed eviscerated poultry,

food business operators must ensure that separate rooms are available for that purpose.

CHAPTER IV: SLAUGHTER HYGIENE

Food business operators operating slaughterhouses in which poultry or lagomorphs are slaughtered must ensure
compliance with the following requirements.

1. (a) Meat from animals other than those referred to in (b) must not be used for human consumption if they die

otherwise than by being slaughtered in the slaughterhouse.

(b) Only live animals intended for slaughter may be brought into the slaughter premises, with the exception of:

(i) delayed eviscerated poultry, geese and ducks reared for the production of ‘foie gras’ and birds that are not
considered as domestic but which are farmed as domestic animals, if slaughtered at the farm in accordance
with Chapter VI;

(ii) farmed game slaughtered at the place of production in accordance with Section III; and

(iii) small wild game in accordance with Section IV, Chapter III.

2. Slaughterhouse operators must follow the instructions of the competent authority to ensure that ante-mortem

inspection is carried out under suitable conditions.

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3. 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.

4. Animals brought into the slaughter room must be slaughtered without undue delay.

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

6. Slaughterhouse operators must follow the instructions of the competent authority to ensure that the post-mortem
inspection is carried out under suitable conditions, and in particular that slaughtered animals can be inspected
properly.

7. After post-mortem inspection:

(a) parts unfit for human consumption must be removed as soon as possible from the clean sector of the

establishment;

(b) meat detained or declared unfit for human consumption and inedible by-products must not come into contact

with meat declared fit for human consumption; and

(c) viscera or parts of viscera remaining in the carcase, except for the kidneys, must be removed entirely, if possible,

and as soon as possible, unless otherwise authorised by the competent authority.

8. After inspection and evisceration, slaughtered animals must be cleaned and chilled to not more than 4 °C as soon as

possible, unless the meat is cut while warm.

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

(a) Every precaution must be taken to avoid 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 and at least once a day.

10. Sick or suspect animals, and animals 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 AND AFTER CUTTING AND BONING

Food business operators must ensure that cutting and boning of meat of poultry and lagomorphs takes place in
accordance with the following requirements.

1. The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food

business operators must ensure in particular that:

(a) meat intended for cutting is brought into the workrooms progressively as needed;

(b) during cutting, boning, trimming, slicing, dicing, wrapping and packaging, the temperature of the meat is
maintained at not more than 4 °C by means of an ambient temperature of 12 °C or an alternative system
having an equivalent effect; and

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

2. However, meat may be boned and cut prior to reaching the temperature referred to in point 1(b) when the cutting
room is on the same site as the slaughter premises, provided that it is transferred to the cutting room either:

(a) directly from the slaughter premises; or

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(b) after a waiting period in a chilling or refrigerating room.

3. As soon as it is cut and, where appropriate, packaged, the meat must be chilled to the temperature referred to in

point 1(b).

4. Exposed meat must be stored and transported separately from packaged meat, unless stored or transported at
different times or in such a way that the packaging material and the manner of storage or transport cannot be a
source of contamination for the meat.

CHAPTER VI: SLAUGHTER ON THE FARM

Food business operators may slaughter poultry referred to in Chapter IV, point 1(b)(i), on the farm only with the
authorisation of the competent authority and in compliance with the following requirements.

1. The farm must undergo regular veterinary inspection.

2. The food business operator must inform the competent authority in advance of the date and time of slaughter.

3. The holding must have facilities for concentrating the birds to allow an ante-mortem inspection of the group to be

made.

4. The holding must have premises suitable for the hygienic slaughter and further handling of the birds.

5. Animal welfare requirements must be complied with.

6. The slaughtered birds must be accompanied to the slaughterhouse by a declaration by the food business operator
who reared the animal indicating any veterinary products or other treatments administered to the animal, dates of
administration and withdrawal periods, and the date and time of slaughter.

7. The slaughtered animal must be accompanied to the slaughterhouse by a certificate issued by the official veterinarian

or approved veterinarian in accordance with Regulation (EC) No . . ./2004 (1).

8. In the case of poultry reared for the production of

the uneviscerated birds must be transported
immediately and, if necessary, refrigerated to a slaughterhouse or cutting plant. They must be eviscerated within
24 hours of slaughter under the supervision of the competent authority.

‘foie gras’,

9. Delayed eviscerated poultry obtained at the farm of production may be kept for up to 15 days at a temperature of
not more than 4 °C. It must then be eviscerated in a slaughterhouse or in a cutting plant located in the same Member
State as the farm of production.

SECTION III: MEAT OF FARMED GAME

1. The provisions of Section I apply to the production and placing on the market of meat from even-toed farmed game

mammals (Crevice and Suede), unless the competent authority considers them inappropriate.

2. The provisions of Section II apply to the production and placing on the market of meat from ratites. However, those
of Section I apply where the competent authority considers them appropriate. Appropriate facilities must be
provided, adapted to the size of the animals.

3. Notwithstanding points 1 and 2, food business operators may slaughter farmed ratites and farmed ungulates referred

to in point 1 at the place of origin with the authorisation of the competent authority if:

(a)

the animals cannot be transported, to avoid any risk for the handler or to protect the welfare of the animals;

(b) the herd undergoes regular veterinary inspection;

(c)

the owner of the animals submits a request;

(1) See page 82 of this Official Journal.

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(d) the competent authority is informed in advance of the date and time of slaughter of the animals;

(e)

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

(f)

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

(g) animal welfare requirements are complied with;

(h) slaughtered and bled animals are transported to the slaughterhouse hygienically and without undue delay. If
transport takes more than two hours, the animals are, if necessary, refrigerated. Evisceration may take place on
the spot, under the supervision of the veterinarian;

(i) a declaration by the food business operator who reared the animals, stating their identity and indicating any
treatments administered, dates of administration and withdrawal periods,

veterinary products or other
accompanies the slaughtered animals to the slaughterhouse; and

(j) during transport to the approved establishment, a certificate issued and signed by the official veterinarian or
approved veterinarian, attesting to a favourable result of the ante-mortem inspection, correct slaughter and
bleeding and the date and time of slaughter, accompanies the slaughtered animals.

4. Food business operators may also slaughter bison on the farm in accordance with paragraph 3 in exceptional

circumstances.

SECTION IV: WILD GAME MEAT

CHAPTER I: TRAINING OF HUNTERS IN HEALTH AND HYGIENE

1. Persons who hunt wild game with a view to placing it on the market for human consumption must have sufficient
knowledge of the pathology of wild game, and of the production and handling of wild game and wild game meat
after hunting, to undertake an initial examination of wild game on the spot.

2. At least one member of every hunting team must have the knowledge referred to in paragraph 1. References in this

Section to a ‘trained person’ are references to that person.

3. The trained person may be the gamekeeper or the game manager if he or she is part of the hunting team or located
in the immediate vicinity of where hunting is taking place. In the latter case, the hunter must present the wild game
to the gamekeeper or game manager and inform them of any abnormal behaviour observed before killing.

4. Training must be provided to the satisfaction of the competent authority to enable hunters to become trained

persons. It should cover at least the following subjects:

(a) the normal anatomy, physiology and behaviour of wild game;

(b) abnormal behaviour and pathological changes in wild game due to diseases, environmental contamination or

other factors which may affect human health after consumption;

(c) the hygiene rules and proper techniques for the handling, transportation, evisceration etc. of wild game animals

after killing; and

(d) legislation and administrative provisions on the animal and public health and hygiene conditions governing the

placing on the market of wild game.

5. The competent authority should encourage hunters' organisations to provide such training.

CHAPTER II: HANDLING OF LARGE WILD GAME

1. After killing, large wild game must have their stomachs and intestines removed as soon as possible and, if necessary,

be bled.

2. The trained person must carry out an examination of the body, and of any viscera removed, to identify any
characteristics that may indicate that the meat presents a health risk. The examination must take place as soon as
possible after killing.

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3. Meat of large wild game may be placed on the market only if the body is transported to a game-handling
establishment as soon as possible after the examination referred to in point 2. The viscera must accompany the
body as specified in point 4. The viscera must be identifiable as belonging to a given animal.

4. (a) If no abnormal characteristics are found during the examination referred to in paragraph 2, no abnormal
behaviour was observed before killing, and there is no suspicion of environmental contamination, the trained
person must attach to the animal body a numbered declaration stating this. This declaration must also indicate
the date, time and place of killing. In this case, the head and the viscera need not accompany the body, except in
the case of species susceptible to Trichinosis (porcine animals, solipeds and others), whose head (except for tusks)
and diaphragm must accompany the body. However, hunters must comply with any additional requirements
in particular to permit the monitoring of certain
imposed in the Member State where hunting takes place,
residues and substances in accordance with Directive 96/23/EC;

(b) In other circumstances, the head (except for tusks, antlers and horns) and all the viscera except for the stomach
and intestines must accompany the body. The trained person who carried out the examination must inform the
competent authority of the abnormal characteristics, abnormal behaviour or suspicion of environmental contami-
nation that prevented him or her from making a declaration in accordance with (a);

(c) If no trained person is available to carry out the examination referred to in paragraph 2 in a particular case, the
head (except for tusks, antlers and horns) and all the viscera except for the stomach and the intestines must
accompany the body.

5. Chilling must begin within a reasonable period of time after killing and achieve a temperature throughout the meat

of not more than 7 °C. Where climatic conditions so permit, active chilling is not necessary.

6. During transport to the game-handling establishment, heaping must be avoided.

7. Large wild game delivered to a game-handling establishment must be presented to the competent authority for

inspection.

8. In addition, unskinned large wild game may be skinned and placed on the market only if:

(a) before skinning, it is stored and handled separately from other food and not frozen; and

(b) after skinning, it undergoes a final inspection in accordance with Regulation (EC) No . . ./2004 (1).

9. The rules laid down in Section I, Chapter V, apply to the cutting and boning of large wild game.

CHAPTER III: HANDLING OF SMALL WILD GAME

1. The trained person must carry out an examination to identify any characteristics that may indicate that the meat

presents a health risk. The examination must take place as soon as possible after killing.

2. If abnormal characteristics are found during the examination, abnormal behaviour was observed before killing, or

environmental contamination is suspected, the trained person must inform the competent authority.

3. Meat of small wild game may be placed on the market only if the body is transported to a game-handling

establishment as soon as possible after the examination referred to in point 1.

4. Chilling must begin within a reasonable period of time of killing and achieve a temperature throughout the meat of

not more than 4 °C. Where climatic conditions so permit, active chilling is not necessary.

5. Evisceration must be carried out, or completed, without undue delay upon arrival at the game-handling estab-

lishment, unless the competent authority permits otherwise.

6. Small wild game delivered to a game-handling establishment must be presented to the competent authority for

inspection.

7. The rules laid down in Section II, Chapter V, apply to the cutting and boning of small wild game.

(1) See page 82 of this Official Journal.

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SECTION V: MINCED MEAT, MEAT PREPARATIONS AND MECHANICALLY SEPARATED MEAT (MSM)

CHAPTER I: REQUIREMENTS FOR PRODUCTION ESTABLISHMENTS

Food business operators operating establishments producing minced meat, meat preparations or MSM must ensure that
they:

1. are constructed so as to avoid contamination of meat and products, in particular by:

(a) allowing constant progress of the operations; or

(b) ensuring separation between the different production batches;

2. have rooms for the separate storage of packaged and exposed meat and products, unless stored at different times or
in such a way that the packaging material and the manner of storage cannot be a source of contamination for the
meat or products;

3. have rooms equipped to ensure compliance with the temperature requirements laid down in Chapter III;

4. have equipment for washing hands used by staff handling exposed meat and products with taps designed to prevent

the spread of contamination; and

5. have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an

equivalent effect.

CHAPTER II: REQUIREMENTS FOR RAW MATERIAL

Food business operators producing minced meat, meat preparations or MSM must ensure that the raw materials used
satisfy the following requirements.

1. The raw material used to prepare minced meat must meet the following requirements.

(a)

It must comply with the requirements for fresh meat;

(b) It must derive from skeletal muscle, including adherent fatty tissues;

(c)

It must not derive from:

(i) scrap cuttings and scrap trimmings (other than whole muscle cuttings);

(ii) MSM;

(iii) meat containing bone fragments or skin; or

(iv) 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, bone scrapings and the muscles of the diaphragm (unless the serosa has been
removed).

2. The following raw material may be used to prepare meat preparations:

(a)

fresh meat;

(b) meat meeting the requirements of point 1; and

(c)

if the meat preparation is clearly not intended to be consumed without first undergoing heat treatment:

(i) meat derived from the mincing or fragmentation of meat meeting the requirements of point 1 other than

point 1(c)(i); and

(ii) MSM meeting the requirements of Chapter III, point 3(d).

3. The raw material used to produce MSM must meet the following requirements.

(a)

It must comply with the requirements for fresh meat;

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(b) The following material must not be used to produce MSM:

(i) for poultry, the feet, neckskin and head; and

(ii) for other animals, the bones of the head, feet, tails, femur, tibia, fibula, humerus, radius and ulna.

CHAPTER III: HYGIENE DURING AND AFTER PRODUCTION

Food business operators producing minced meat, meat preparations or MSM must ensure compliance with the following
requirements.

1. The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food

business operators must ensure in particular that the meat used is:

(a) at a temperature of not more than 4 °C for poultry, 3 °C for offal and 7 °C for other meat; and

(b) brought into the preparation room progressively as needed.

2. The following requirements apply to the production of minced meat and meat preparations.

(a) Unless the competent authority authorises boning immediately before mincing, frozen or deep-frozen meat used
for the preparation of minced meat or meat preparations must be boned before freezing. It may be stored only
for a limited period.

(b) When prepared from chilled meat, minced meat must be prepared:

(i) in the case of poultry, within no more than 3 days of their slaughter;

(ii) in the case of animal other than poultry, within no more than 6 days of their slaughter; or

(iii) within no more than 15 days from the slaughter of the animals in the case of boned, vacuum-packed beef

and veal.

(c)

Immediately after production, minced meat and meat preparations must be wrapped or packaged and be:

(i) chilled to an internal temperature of not more than 2 °C for minced meat and 4 °C for meat preparations; or

(ii) frozen to an internal temperature of not more than – 18 °C.

These temperature conditions must be maintained during storage and transport.

3. The following requirements apply to the production and use of MSM produced using techniques that do not alter the
structure of the bones used in the production of MSM and the calcium content of which is not significantly higher
than that of minced meat.

(a) Raw material for deboning from an on-site slaughterhouse must be no more than 7 days old; otherwise, raw
material for deboning must be no more than 5 days old. However, poultry carcases must be no more than 3 days
old.

(b) Mechanical separation must take place immediately after deboning.

(c)

If not used immediately after being obtained, MSM must be wrapped or packaged and then chilled to a
temperature of not more than 2 °C or frozen to an internal temperature of not more than – 18 °C. These
temperature requirements must be maintained during storage and transport.

(d) If the food business operator has carried out analyses demonstrating that MSM complies with the microbiological
criteria for minced meat adopted in accordance with Regulation (EC) No . . ./2004 (1) it may be used in meat
preparations that are clearly not intended to be consumed without first undergoing heat treatment and in meat
products.

(e) MSM not shown to comply with the criteria referred to in (d) may be used only to manufacture heat-treated meat

products in establishments approved in accordance with this Regulation.

(1) See page 1 of this Official Journal.

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4. The following requirements apply to the production and use of MSM produced using techniques other than those

mentioned in point 3.

(a) Raw material for deboning from an on-site slaughterhouse must be no more than 7 days old; otherwise, raw
material for deboning must be no more than 5 days old. However, poultry carcases must be no more than 3 days
old.

(b) If mechanical separation does not take place immediately after deboning the flesh-bearing bones must be stored
and transported at a temperature of not more than 2 °C or, if frozen, at a temperature of not more than – 18 °C.

(c) Flesh-bearing bones obtained from frozen carcases must not be refrozen.

(d) If not used within one hour of being obtained, MSM must be chilled immediately to a temperature of not more

than 2 °C.

(e)

If, after chilling, MSM is not processed within 24 hours, it must be frozen within 12 hours of production and
reach an internal temperature of not more than – 18 °C within six hours.

(f) Frozen MSM must be wrapped or packaged before storage or transport, must not be stored for more than three
months and must be maintained at a temperature of not more than – 18 °C during storage and transport.

(g) MSM may be used only to manufacture heat-treated meat products in establishments approved in accordance

with this Regulation.

5. Minced meat, meat preparations and MSM must not be re-frozen after thawing.

CHAPTER IV: LABELLING

1. In addition to the requirements of Directive 2000/13/EC (1), food business operators must ensure compliance with
the requirement of point 2 if, and to the extent that, national rules in the Member State in the territory of which the
product is placed on the market so require.

2. Packages intended for supply to the final consumer containing minced meat from poultry or solipeds or meat
preparations containing MSM must bear a notice indicating that such products should be cooked before
consumption.

SECTION VI: MEAT PRODUCTS

1. Food business operators must ensure that the following items are not used in the preparation of meat products:

(a) genital organs of either female or male animals, except testicles;

(b) urinary organs, except the kidneys and the bladder;

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

(d) eyes and eyelids;

(e)

the external auditory meatus;

(f) horn tissue; and

(g)

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

2. All meat, including minced meat and meat preparations, used to produce meat product must meet the requirements
for fresh meat. However, minced meat and meat preparations used to produce meat products need not satisfy other
specific requirements of Section V.

(1) Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the
Member States relating to the labelling, presentation and advertising of foodstuffs (OJ L 109, 6.5.2000, p. 29). Directive as amended
by Directive 2001/101/EC (OJ L 310, 28.11.2001, p. 19).

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SECTION VII: LIVE BIVALVE MOLLUSCS

1. This Section applies to live bivalve molluscs. With the exception of the provisions on purification, it also applies to

live echinoderms, tunicates and marine gastropods.

2. Chapters I to VIII apply to animals harvested from production areas that the competent authority has classified in
accordance with Regulation (EC) No . . ./2004 (1). Chapter IX applies to pectinidae harvested outside those areas.

3. Chapters V, VI, VIII and IX, and paragraph 3 of Chapter VII, apply to retail.

4. The requirements of this Section supplement those laid down in Regulation (EC) No . . ./2004 (2).

(a)

In the case of operations that take place before live bivalve molluscs arrive at a dispatch or purification centre,
they supplement the requirements of Annex I to that Regulation.

(b) In the case of other operations, they supplement the requirements of Annex II to that Regulation.

CHAPTER I: GENERAL REQUIREMENTS FOR THE PLACING ON THE MARKET OF LIVE BIVALVE MOLLUSCS

1. Live bivalve molluscs may not be placed on the market for retail sale otherwise than via a dispatch centre, where an

identification mark must be applied in accordance with Chapter VII.

2. Food business operators may accept batches of live bivalve molluscs only if the documentary requirements set out in

paragraphs 3 to 7 have been complied with.

3. Whenever a food business operator moves a batch of live bivalve molluscs between establishments, up to and
including the arrival of the batch at a dispatch centre or processing establishment, a registration document must
accompany the batch.

4. The registration document must be in at least one official language of the Member State in which the receiving

establishment is located and contain at least the information specified below.

(a)

In the case of a batch of live bivalve molluscs sent from a production area, the registration document must
contain at least the following information:

(i) the gatherer's identity and address;

(ii) the date of harvesting;

(iii) the location of the production area described in as precise detail as is practicable or by a code number;

(iv) the health status of the production area;

(v) the shellfish species and quantity; and

(vi) the destination of the batch.

(b) In the case of a batch of live bivalve molluscs sent from a relaying area, the registration document must contain

at least the information referred to in (a) and the following information:

(i) the location of the relaying area; and

(ii) the duration of relaying.

(c)

In the case of a batch of live bivalve molluscs sent from a purification centre, the registration document must
contain at least the information referred to in (a) and the following information:

(i) the address of the purification centre;

(ii) the duration of purification; and

(iii) the dates on which the batch entered and left the purification centre.

(1) See page 82 of this Official Journal.
(2) See page 1 of this Official Journal.

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5. Food business operators sending batches of live bivalve molluscs must complete the relevant sections of the regi-
stration document so that they are easy to read and cannot be altered. Food business operators receiving batches
must date-stamp the document on receipt of the batch or record the date of receipt in another manner.

6. Food business operators must keep a copy of the registration document relating to each batch sent and received for
at least twelve months after its dispatch or receipt (or such longer period as the competent authority may specify).

7. However, if:

(a) the staff gathering live bivalve molluscs also operate the dispatch centre, purification centre, relaying area or

processing establishment receiving the live bivalve molluscs; and

(b) a single competent authority supervises all the establishments concerned,

registration documents are not necessary if that competent authority so permits.

CHAPTER II: HYGIENE REQUIREMENTS FOR THE PRODUCTION AND HARVESTING OF LIVE BIVALVE MOLLUSCS

A. REQUIREMENTS FOR PRODUCTION AREAS

1. Gatherers may only harvest live bivalve molluscs from production areas with fixed locations and boundaries that the
competent authority has classified — where appropriate, in cooperation with food business operators — as being of
class A, B or C in accordance with Regulation (EC) No . . ./2004 (1).

2. Food business operators may place live bivalve molluscs collected from class A production areas on the market for

direct human consumption only if they meet the requirements of Chapter V.

3. Food business operators may place live bivalve molluscs collected from class B production areas on the market for

human consumption only after treatment in a purification centre or after relaying.

4. Food business operators may place live bivalve molluscs collected from class C production areas on the market for

human consumption only after relaying over a long period in accordance with Part C of this Chapter.

5. After purification or relaying,

live bivalve molluscs from class B or C production areas must meet all of the
live bivalve molluscs from such areas that have not been submitted for
requirements of Chapter V. However,
purification or relaying may be sent
to
to a processing establishment, where they must undergo treatment
eliminate pathogenic microorganisms (where appropriate, after removal of sand, mud or slime in the same or
another establishment). The permitted treatment methods are:

(a) sterilisation in hermetically sealed containers; and

(b) heat treatments involving:

(i) immersion in boiling water for the period required to raise the internal temperature of the mollusc flesh to
not less than 90 °C and maintenance of this minimum temperature for a period of not less than 90 seconds;

(ii) cooking for three to five minutes in an enclosed space where the temperature is between 120 and 160 °C
and the pressure is between 2 and 5 kg/cm2, followed by shelling and freezing of the flesh to a core
temperature of – 20 °C; and

(iii) steaming under pressure in an enclosed space satisfying the requirements relating to cooking time and the
internal temperature of the mollusc flesh mentioned under (i). A validated methodology must be used.
Procedures based on the HACCP principles must be in place to verify the uniform distribution of heat.

6. Food business operators must not produce live bivalve molluscs in, or harvest them from, areas that the competent
authority has not classified, or which are unsuitable for health reasons. Food business operators must take account of
any relevant information concerning areas' suitability for production and harvesting, including information obtained
from own-checks and the competent authority. They must use this information, particularly information on environ-
mental and weather conditions, to determine the appropriate treatment to apply to harvested batches.

(1) See page 82 of this Official Journal.

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B. REQUIREMENTS FOR HARVESTING AND HANDLING FOLLOWING HARVESTING

Food business operators harvesting live bivalve molluscs, or handling them immediately after harvesting, must ensure
compliance with the following requirements.

1. Harvesting techniques and further handling must not cause additional contamination or excessive damage to the
shells or tissues of the live bivalve molluscs or result in changes significantly affecting their suitability for treatment
by purification, processing or relaying. Food business operators must in particular:

(a) adequately protect live bivalve molluscs from crushing, abrasion or vibration;

(b) not expose live bivalve molluscs to extreme temperatures;

(c) not re-immerse live bivalve molluscs in water that could cause additional contamination; and

(d) if carrying out conditioning in natural sites, use only areas that the competent authority has classified as being of

class A.

2. Means of transport must permit adequate drainage, be equipped to ensure the best survival conditions possible and

provide efficient protection against contamination.

C. REQUIREMENTS FOR RELAYING LIVE BIVALVE MOLLUSCS

Food business operators relaying live bivalve molluscs must ensure compliance with the following requirements.

1. Food business operators may use only those areas that the competent authority has approved for relaying live bivalve
molluscs. Buoys, poles or other fixed means must clearly identify the boundaries of the sites. There must be a
minimum distance between relaying areas, and also between relaying areas and production areas, so as to minimise
any risk of the spread of contamination.

2. Conditions for relaying must ensure optimal conditions for purification. In particular, food business operators must:

(a) use techniques for handling live bivalve molluscs intended for relaying that permit the resumption of filter-

feeding activity after immersion in natural waters;

(b) not relay live bivalve molluscs at a density that prevents purification;

(c)

immerse live bivalve molluscs in seawater at the relaying area for an appropriate period, fixed depending on the
water temperature, which period must be of at least two months' duration unless the competent authority agrees
to a shorter period on the basis of the food business operator's risk analysis; and

(d) ensure sufficient separation of sites within a relaying area to prevent mixing of batches; the ‘all in, all out’ system
must be used, so that a new batch cannot be brought in before the whole of the previous batch has been
removed.

3. Food business operators managing relaying areas must keep permanent records of the source of live bivalve molluscs,
relaying periods, relaying areas used and the subsequent destination of the batch after relaying, for inspection by the
competent authority.

CHAPTER III: STRUCTURAL REQUIREMENTS FOR DISPATCH AND PURIFICATION CENTRES

1. The location of premises on land must not be subject to flooding by ordinary high tides or run-off from surrounding

areas.

2. Tanks and water storage containers must meet the following requirements:

(a)

Internal surfaces must be smooth, durable, impermeable and easy to clean.

(b) They must be constructed so as to allow complete draining of water.

(c) Any water intake must be situated in a position that avoids contamination of the water supply.

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3. In addition, in purification centres, purification tanks must be suitable for the volume and type of products to be

purified.

CHAPTER IV: HYGIENE REQUIREMENTS FOR PURIFICATION AND DISPATCH CENTRES

A. REQUIREMENTS FOR PURIFICATION CENTRES

Food business operators purifying live bivalve molluscs must ensure compliance with the following requirements.

1. Before purification commences, live bivalve molluscs must be washed free of mud and accumulated debris using

clean water.

2. Operation of the purification system must allow live bivalve molluscs rapidly to resume and to maintain filter-feeding
activity, to eliminate sewage contamination, not to become re-contaminated and to be able to remain alive in a
suitable condition after purification for wrapping, storage and transport before being placed on the market.

3. 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 achieve compliance with allow the health
standards of Chapter V and microbiological criteria adopted in accordance with Regulation (EC) No . . ./2004 (1).

4. Should a purification tank contain several batches of live bivalve molluscs, they must be of the same species and the
length of the treatment must be based on the time required by the batch needing the longest period of purification.

5. Containers used to hold live bivalve molluscs in purification systems must have a construction that allows clean
seawater to flow through. The depth of layers of live bivalve molluscs must not impede the opening of shells during
purification.

6. No crustaceans, fish or other marine species may be kept in a purification tank in which live bivalve molluscs are

undergoing purification.

7. 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. REQUIREMENTS FOR DISPATCH CENTRES

Food business operators operating dispatch centres must ensure compliance with the following requirements.

1. Handling of live bivalve molluscs, particularly conditioning, calibration, wrapping and packing, must not cause

contamination of the product or affect the viability of the molluscs.

2. Before dispatch, the shells of live bivalve molluscs must be washed thoroughly with clean water.

3. Live bivalve molluscs must come from:

(a) a class A production area;

(b) a relaying area;

(c) a purification centre; or

(d) another dispatch centre.

4. The requirements laid down in points 1 and 2 also apply to dispatch centres situated on board vessels. Molluscs

handled in such centres must come from a class A production area or a relaying area.

(1) See page 1 of this Official Journal.

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CHAPTER V: HEALTH STANDARDS FOR LIVE BIVALVE MOLLUSCS

In addition to ensuring compliance with microbiological criteria adopted in accordance with Regulation (EC)
No . . ./2004 (1), food business operators must ensure that live bivalve molluscs placed on the market for human
consumption meet the standards laid down in this Chapter.

1. They must have organoleptic characteristics associated with freshness and viability, including shells free of dirt, an

adequate response to percussion and normal amounts of intravalvular liquid.

2. They must not contain marine biotoxins in total quantities (measured in the whole body or any part edible

separately) that exceed the following limits:

(a)

for Paralytic Shellfish Poison (PSP), 800 micrograms per kilogram;

(b) for Amnesic Shellfish Poison (ASP), 20 milligrams of domoic acid per kilogram;

(c)

for okadaic acid, dinophysistoxins and pectenotoxins together, 160 micrograms of okadaic acid equivalents per
kilogram;

(d) for yessotoxins, 1 milligram of yessotoxin equivalent per kilogram; and

(e)

for azaspiracids, 160 micrograms of azaspiracid equivalents per kilogram.

CHAPTER VI: WRAPPING AND PACKAGING OF LIVE BIVALVE MOLLUSCS

1. Oysters must be wrapped or packaged with the concave shell downwards.

2. Individual consumer-size packages of live bivalve molluscs must be closed and remain closed after leaving the

dispatch centre and until presented for sale to the final consumer.

CHAPTER VII: IDENTIFICATION MARKING AND LABELLING

1. The label, including the identification mark, must be waterproof.

2. In addition to the general requirements for identification marks contained in Annex II, Section I, the following

information must be present on the label:

(a) the species of bivalve mollusc (common name and scientific name); and

(b) the date of packaging, comprising at least the day and the month.

By way of derogation from Directive 2000/13/EC, the date of minimum durability may be replaced by the entry
‘these animals must be alive when sold’.

3. The retailer must keep the label attached to the packaging of live bivalve molluscs that are not in individual

consumer-size packages for at least 60 days after splitting up the contents.

CHAPTER VIII: OTHER REQUIREMENTS

1. Food business operators storing and transporting live bivalve molluscs must ensure that

they are kept at a

temperature that does not adversely affect food safety or their viability.

2. Live bivalve molluscs must not be re-immersed in, or sprayed with, water after they have been packaged for retail

sale and left the dispatch centre.

CHAPTER IX: SPECIFIC REQUIREMENTS FOR PECTINIDAE HARVESTED OUTSIDE CLASSIFIED PRODUCTION
AREAS

Food business operators harvesting pectinidae outside classified production areas or handling such pectinidae must
comply with the following requirements.

1. Pectinidae may not be placed on the market unless they are harvested and handled in accordance with Chapter II,

Part B, and meet the standards laid down in Chapter V, as proved by a system of own-checks.

(1) See page 1 of this Official Journal.

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2. In addition, where data from official monitoring programmes enable the competent authority to classify fishing
grounds — where appropriate, in cooperation with food business operators — the provisions of Chapter II, Part A,
apply by analogy to pectinidae.

3. Pectinidae may not be placed on the market for human consumption otherwise than via a fish auction, a dispatch
centre or a processing establishment. When they handle pectinidae, food business operators operating such estab-
lishments must
inform the competent authority and, as regards dispatch centres, comply with the relevant
requirements of Chapters III and IV.

4. Food business operators handling pectinidae must comply:

(a) with the documentary requirements of Chapter I, points 3 to 7, where applicable. In this case, the registration

document must clearly indicate the location of the area where the pectinidae were harvested; or

(b) as regards packaged pectinidae, and wrapped pectinidae if the wrapping provides protection equivalent to that of

packaging, with the requirements of Chapter VII concerning identification marking and labelling.

SECTION VIII: FISHERY PRODUCTS

1. This Section does not apply to bivalve molluscs, echinoderms, tunicates and marine gastropods when placed on the
market live. With the exception of Chapters I and II, it applies to such animals when not placed on the market live,
in which case they must have been obtained in accordance with Section VII.

2. Chapter III, Parts A, C and D, Chapter IV and Chapter V apply to retail.

3. The requirements of this Section supplement those laid down in Regulation (EC) No . . ./2004 (1).

(a)

In the case of establishments, including vessels, engaged in primary production and associated operations they
supplement the requirements of Annex I to that Regulation.

(b) In the case of other establishments, including vessels, they supplement the requirements of Annex II to that

Regulation.

4. In relation to fishery products:

(a) primary production covers the farming, fishing and collection of live fishery products with a view to their being

placed on the market; and

(b) associated operations cover any of the following operations, if carried out on board fishing vessels: slaughter,

bleeding, heading, gutting, removing fins, refrigeration and wrapping; they also include:

1. the transport and storage of fishery products the nature of which has not been substantially altered, including

live fishery products, within fish farms on land and,

2. the transport of fishery products the nature of which has not been substantially altered, including live fishery

products, from the place of production to the first establishment of destination.

CHAPTER I: REQUIREMENTS FOR VESSELS

Food business operators must ensure that:

1. vessels used to harvest fishery products from their natural environment, or to handle or process them after

harvesting, comply with the structural and equipment requirements laid down in Part I; and

2. operations carried out on board vessels take place in accordance with the rules laid down in Part II.

I. STRUCTURAL AND EQUIPMENT REQUIREMENTS

A. Requirements for all vessels

1. 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.

(1) See page 1 of this Official Journal.

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2. Surfaces with which fishery products come into contact must be of suitable corrosion-resistant material that is

smooth and easy to clean. Surface coatings must be durable and non-toxic.

3. Equipment and material used for working on fishery products must be made of corrosion-resistant material that is

easy to clean and disinfect.

4. When vessels have a water intake for water used with fishery products, it must be situated in a position that avoids

contamination of the water supply.

B. Requirements for vessels designed and equipped to preserve fresh fishery products for more than twenty-four hours

1. Vessels designed and equipped to preserve fishery products for more than twenty-four hours must be equipped with

holds, tanks or containers for the storage of fishery products at the temperatures laid down in Chapter VII.

2. 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. Holds and containers used for the storage
of fishery products must ensure their preservation under satisfactory conditions of hygiene and, where necessary,
ensure that melt water does not remain in contact with the products.

3. In vessels equipped for chilling fishery products in cooled clean seawater, tanks must incorporate devices for
achieving a uniform temperature throughout the tanks. Such devices must achieve a chilling rate that ensures
that the mix of fish and clean seawater reaches not more than 3 °C 6 hours after loading and not more than
0 °C after 16 hours and allow the monitoring and, where necessary, recording of temperatures.

C. Requirements for freezer vessels

Freezer vessels must:

1. have freezing equipment with sufficient capacity to lower the temperature rapidly so as to achieve a core temperature

of not more than – 18 °C;

2. have refrigeration equipment with sufficient capacity to maintain fishery products in the storage holds at not more
than – 18 °C. 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; and

3. meet the requirements for vessels designed and equipped to preserve fishery products for more than 24 hours laid

down in Part B, paragraph 2.

D. Requirements for 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 from the sun or the
elements and from any source of contamination;

(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 disinfect 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;

(f)

special equipment for disposing 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;

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(g) a water intake situated in a position that avoids contamination of the water supply; and

(h) hand-washing equipment for use by the staff engaged in handling exposed fishery products with taps designed to

prevent the spread of contamination.

2. However, factory vessels on board which crustaceans and molluscs are cooked, chilled and wrapped, need not meet
the requirements of paragraph 1 if no other form of handling or processing takes place on board such vessels.

3. Factory vessels that freeze fishery products must have equipment meeting the requirements for freezer vessels laid

down in Part C, points 1 and 2.

II. HYGIENE REQUIREMENTS

1. When in use, the parts of vessels or containers set aside for the storage of fishery products must be kept clean and
maintained in good repair and condition. In particular, they must not be contaminated by fuel or bilge water.

2. 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 potable
water or, where appropriate, clean water.

3. Fishery products must be handled and stored so as to prevent bruising. Handlers may use spiked instruments to

move large fish or fish which might injure them, provided that the flesh of the products suffers no damage.

4. Fishery products other than those kept alive must undergo chilling as soon as possible after loading. However, when

chilling is not possible, fishery products must be landed as soon as possible.

5. Ice used to chill fishery products must be made from potable water or clean water.

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 or clean water. In
that event, the viscera and parts that 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 a temperature approaching that of melting ice, or be frozen.

7. Where freezing in brine of whole fish intended for canning is practised, a temperature of not more than – 9 °C must

be achieved for the product. The brine must not be a source of contamination for the fish.

CHAPTER II: REQUIREMENTS DURING AND AFTER LANDING

1. Food business operators responsible for the unloading and landing of fishery products must:

(a) ensure that unloading and landing equipment that comes into contact with fishery products is constructed of
material that is easy to clean and disinfect and maintained in a good state of repair and cleanliness; and

(b) avoid contamination of fishery products during unloading and landing, in particular by:

(i) carrying out unloading and landing operations rapidly;

(ii) placing fishery products without delay in a protected environment at the temperature specified in Chapter

VII; and

(iii) not using equipment and practices that cause unnecessary damage to the edible parts of the fishery products.

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2. Food business operators responsible for auction and wholesale markets or parts thereof where fishery products are

displayed for sale must ensure compliance with the following requirements.

(a)

(i) There must be lockable facilities for the refrigerated storage of detained fishery products and separate lockable

facilities for the storage of fishery products declared unfit for human consumption.

(ii) If the competent authority so requires, there must be an adequately equipped lockable facility or, where

needed, room for the exclusive use of the competent authority.

(b) At the time of display or storage of fishery products:

(i) the premises must not be used for other purposes;

(ii) vehicles emitting exhaust fumes likely to impair the quality of fishery products must not have access to the

premises;

(iii) persons having access to the premises must not introduce other animals; and

(iv) the premises must be well lit to facilitate official controls.

3. When chilling was not possible on board the vessel, fresh fishery products, other than those kept alive, must undergo

chilling as soon as possible after landing and be stored at a temperature approaching that of melting ice.

4. Food business operators must cooperate with relevant competent authorities so as to permit them to carry out
official controls in accordance with Regulation (EC) No . . ./2004 (1),
in particular as regards any notification
procedures for the landing of fishery products that the competent authority of the Member State the flag of
which the vessel is flying or the competent authority of the Member State where the fishery products are landed
might consider necessary.

CHAPTER III: REQUIREMENTS FOR ESTABLISHMENTS, INCLUDING VESSELS, HANDLING FISHERY PRODUCTS

Food business operators must ensure compliance with the following requirements, where relevant, in establishments
handling fishery products.

A. REQUIREMENTS FOR FRESH FISHERY PRODUCTS

1. Where chilled, unpackaged products are not distributed, dispatched, prepared or processed immediately after
reaching an establishment on land, they must be stored under ice in appropriate facilities. Re-icing must be
carried out as often as necessary. Packaged fresh fishery products must be chilled to a temperature approaching
that of melting ice.

2. Operations such as heading and gutting must be carried out hygienically. Where gutting is possible from a technical
and commercial viewpoint, it must be carried out as quickly as possible after the products have been caught or
landed. The products must be washed thoroughly with potable water or, on board vessels, clean water immediately
after these operations.

3. Operations such as filleting and cutting must be carried out so as to avoid contamination or spoilage of fillets and
slices. Fillets and slices must not remain on the worktables beyond the time necessary for their preparation. Fillets
and slices must be wrapped and, where necessary, packaged and must be chilled as quickly as possible after their
preparation.

4. Containers used for the dispatch or storage of unpackaged prepared fresh fishery products stored under ice must

ensure that melt water does not remain in contact with the products.

5. Whole and gutted fresh fishery products may be transported and stored in cooled water on board vessels. They may
also continue to be transported in cooled water after landing, and be transported from aquaculture establishments,
until they arrive at the first establishment on land carrying out any activity other than transport or sorting.

(1) See page 82 of this Official Journal.

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B. REQUIREMENTS FOR FROZEN PRODUCTS

Establishments on land that freeze fishery products must have equipment that satisfies the requirements laid down for
freezer vessels in Chapter I, Part I.C, points 1 and 2.

C. REQUIREMENTS FOR MECHANICALLY SEPARATED FISHERY PRODUCTS

Food business operators manufacturing mechanically separated fishery products must ensure compliance with the
following requirements.

1. The raw materials used must satisfy the following requirements.

(a) only whole fish and bones after filleting may be used to produce mechanically separated fishery products;

(b) all raw materials must be free from guts.

2. The manufacturing process must satisfy the following requirements:

(a) mechanical separation must take place without undue delay after filleting;

(b) if whole fish are used, they must be gutted and washed beforehand;

(c) after production, mechanically separated fishery products must be frozen as quickly as possible or incorporated

in a product intended for freezing or a stabilising treatment.

D. REQUIREMENTS CONCERNING PARASITES

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)

fishery products to be consumed raw or almost raw;

(b) fishery products from the following species, if they are to undergo a cold smoking process in which the internal

temperature of the fishery product is not more than 60 °C:

(i) herring;

(ii) mackerel;

(iii) sprat;

(iv) (wild) Atlantic and Pacific salmon; and

(c) marinated and/or salted fishery products, if the processing is insufficient to destroy nematode larvae.

2. Food business operators need not carry out the treatment required under paragraph 1 if:

(a) epidemiological data are available indicating that the fishing grounds of origin do not present a health hazard

with regard to the presence of parasites; and

(b) the competent authority so authorises.

3. A document from the manufacturer, stating the type of process they have undergone, must accompany fishery
products referred to in paragraph 1 when placed on the market, except when supplied to the final consumer.

CHAPTER IV: REQUIREMENTS FOR PROCESSED FISHERY PRODUCTS

Food business operators cooking crustaceans and molluscs must ensure compliance with the following requirements.

1. Rapid cooling must follow cooking. Water used for this purpose must be potable water or, on board vessels, clean
water. If no other method of preservation is used, cooling must continue until a temperature approaching that of
melting ice is reached.

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2. 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.

3. After shelling or shucking, cooked products must be frozen immediately, or be chilled as soon as possible to the

temperature laid down in Chapter VII.

CHAPTER V: HEALTH STANDARDS FOR FISHERY PRODUCTS

In addition to ensuring compliance with microbiological criteria adopted in accordance with Regulation (EC)
No . . ./2004 (1), food business operators must ensure, depending on the nature of the product or the species, that
fishery products placed on the market for human consumption meet the standards laid down in this Chapter.

A. ORGANOLEPTIC PROPERTIES OF FISHERY PRODUCTS

Food business operators must carry out an organoleptic examination of fishery products. In particular, this examination
must ensure that fishery products comply with any freshness criteria.

B. HISTAMINE

Food business operators must ensure that the limits with regard to histamine are not exceeded.

C. TOTAL VOLATILE NITROGEN

Unprocessed fishery products must not be placed on the market if chemical tests reveal that the limits with regard to
TVB-N or TMA-N have been exceeded.

D. PARASITES

Food business operators must ensure that fishery products have been subjected to a visual examination for the purpose
of detecting visible parasites before being placed on the market. They must not place fishery products that are obviously
contaminated with parasites on the market for human consumption.

E. TOXINS HARMFUL TO HUMAN HEALTH

1. Fishery products derived from poisonous fish of the following families must not be placed on the market: Tetrao-

dontidae, Molidae, Diodontidae and Canthigasteridae.

2. Fishery products containing biotoxins such as ciguatoxin or muscle-paralysing toxins must not be placed on the
market. However, fishery products derived from bivalve molluscs, echinoderms, tunicates and marine gastropods may
be placed on the market if they have been produced in accordance with Section VII and comply with the standards
laid down in Chapter V, point 2, of that Section.

CHAPTER VI: WRAPPING AND PACKAGING OF FISHERY PRODUCTS

1. Receptacles in which fresh fishery products are kept under ice must be water-resistant and ensure that melt water

does not remain in contact with the products.

2. Frozen blocks prepared on board vessels must be adequately wrapped before landing.

3. When fishery products are wrapped on board fishing vessels, food business operators must ensure that wrapping

material:

(a)

is not a source of contamination;

(b) is stored in such a manner that it is not exposed to a risk of contamination;

(c)

intended for re-use is easy to clean and, where necessary, to disinfect.

(1) See page 1 of this Official Journal.

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CHAPTER VII: STORAGE OF FISHERY PRODUCTS

Food business operators storing fishery products must ensure compliance with the following requirements.

1. Fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans and

molluscs, must be maintained at a temperature approaching that of melting ice.

2. Frozen fishery products must be kept at a temperature of not more than – 18 °C 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 not more
than – 9 °C.

3. Fishery products kept alive must be kept at a temperature and in a manner that does not adversely affect food safety

or their viability.

CHAPTER VIII: TRANSPORT OF FISHERY PRODUCTS

Food business operators transporting fishery products must ensure compliance with the following requirements.

1. During transport, fishery products must be maintained at the required temperature. In particular:

(a)

fresh fishery products, thawed unprocessed fishery products, and cooked and chilled products from crustaceans
and molluscs, must be maintained at a temperature approaching that of melting ice;

(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 not more than – 18 °C in all parts of the product,
possibly with short upward fluctuations of not more than 3 °C.

2. Food business operators need not comply with point 1(b) 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, if the
journey is short and the competent authority so permits.

3. If fishery products are kept under ice, melt water must not remain in contact with the products.

4. Fishery products to be placed on the market live must be transported in such a way as not adversely to affect food

safety or their viability.

SECTION IX: RAW MILK AND DAIRY PRODUCTS

CHAPTER I: RAW MILK — PRIMARY PRODUCTION

Food business operators producing or, as appropriate, collecting raw milk must ensure compliance with the
requirements laid down in this Chapter.

I. HEALTH REQUIREMENTS FOR RAW MILK PRODUCTION

1. Raw milk must come from animals:

(a) that do not show any symptoms of infectious diseases communicable to humans through milk;

(b) that are in a good general state of health, present no sign of disease that might result in the contamination of
milk and, in particular, are not suffering from any infection of the genital tract with discharge, enteritis with
diarrhoea and fever, or a recognisable inflammation of the udder;

(c) that do not have any udder wound likely to affect the milk;

(d) to which no unauthorised substances or products have been administered and that have not undergone illegal

treatment within the meaning of Directive 96/23/EC; and

(e)

in respect of which, where authorised products or substances have been administered, the withdrawal periods
prescribed for these products or substances have been observed.

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2. (a) In particular, as regards brucellosis, raw milk must come from:

(i) cows or buffaloes belonging to a herd which, within the meaning of Directive 64/432/EEC (1), is free or

officially free of brucellosis;

(ii) sheep or goats belonging to a holding officially free or free of brucellosis within the meaning of Directive

91/68/EEC (2); or

(iii) females of other species belonging, for species susceptible to brucellosis, to herds regularly checked for that

disease under a control plan that the competent authority has approved.

(b) As regards tuberculosis, raw milk must come from:

(i) cows or buffaloes belonging to a herd which, within the meaning of Directive 64/432/EEC, is officially free of

tuberculosis; or

(ii) females of other species belonging, for species susceptible to tuberculosis, to herds regularly checked for this

disease under a control plan that the competent authority has approved.

(c) If goats are kept together with cows, such goats must be inspected and tested for tuberculosis.

3. However, raw milk from animals that do not meet the requirements of point 2 may be used with the authorisation

of the competent authority:

(a)

in the case of cows or buffaloes that do not show a positive reaction to tests for tuberculosis or brucellosis, nor
any symptoms of these diseases, after having undergone a heat treatment such as to show a negative reaction to
the phosphatase test;

(b) in the case of sheep or goats that do not show a positive reaction to tests for brucellosis, or which have been
vaccinated against brucellosis as part of an approved eradication programme, and which do not show any
symptom of that disease, either:

(i) for the manufacture of cheese with a maturation period of at least two months; or

(ii) after having undergone heat treatment such as to show a negative reaction to the phosphatase test; and

(c)

in the case of females of other species that 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 referred to in point 2(a)(iii) or 2(b)(ii), if treated to ensure its safety.

4. Raw milk from any animal not complying with the requirements of points 1 to 3 — in particular, any animal
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 — must not be used for human consumption.

5. The isolation of animals that are infected, or suspected of being infected, with any of the diseases referred to in point

1 or 2 must be effective to avoid any adverse effect on other animals' milk.

II. HYGIENE ON MILK PRODUCTION HOLDINGS

A. Requirements for premises and equipment

1. Milking equipment, and premises where milk is stored, handled or cooled must be located and constructed so as to

limit the risk of contamination of milk.

2. Premises for the storage of milk must be protected against vermin, have adequate separation from premises where
animals are housed and, where necessary to meet the requirements laid down in Part B, have suitable refrigeration
equipment.

(1) Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and
swine (OJ 121, 29.7.1964, p. 1977). Directive as last amended by Commission Regulation (EC) No 1226/2002 (OJ L 179, 9.7.2002,
p. 13).

(2) Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine
animals (OJ L 46, 19.2.1991, p. 19). Directive as last amended by Commission Decision 2002/261/EC (OJ L 91, 6.4.2002, p. 31).

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3. Surfaces of equipment that are intended to come into contact with milk (utensils, containers, tanks, etc. intended for
milking, collection or transport) must be easy to clean and, where necessary, disinfect and be maintained in a sound
condition. This requires the use of smooth, washable and non-toxic materials.

4. After use, such surfaces must be cleaned and, where necessary, 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 a day, containers and tanks used for the transport of raw milk must be cleaned and disinfected in an
appropriate manner before re-use.

B. Hygiene during milking, collection and transport

1. Milking must be carried out hygienically, ensuring in particular:

(a) that, before milking starts, the teats, udder and adjacent parts are clean;

(b) that milk from each animal is checked for organoleptic or physico-chemical abnormalities by the milker or a
results and that milk presenting such abnormalities is not used for human

method achieving similar
consumption;

(c) that milk from animals showing clinical signs of udder disease is not used for human consumption otherwise

than in accordance with the instructions of a veterinarian;

(d) the identification of animals undergoing medical treatment likely to transfer residues to the milk, and that milk
obtained from such animals before the end of the prescribed withdrawal period is not used for human
consumption; and

(e)

that teat dips or sprays are used only if the competent authority has approved them and in a manner that does
not produce unacceptable residue levels in the milk.

2. Immediately after milking, milk must be held in a clean place designed and equipped to avoid contamination. It must
be cooled immediately to not more than 8 °C in the case of daily collection, or not more than 6 °C if collection is not
daily.

3. During transport the cold chain must be maintained and, on arrival at the establishment of destination, the

temperature of the milk must not be more than 10 °C.

4. Food business operators need not comply with the temperature requirements laid down in points 2 and 3 if the milk

meets the criteria provided for in Part III and either:

(a) the milk is processed within 2 hours of milking; or

(b) a higher temperature is necessary for technological reasons related to the manufacture of certain dairy products

and the competent authority so authorises.

C. Staff hygiene

1. Persons performing milking and/or handling raw milk must wear suitable clean clothes.

2. Persons performing milking must maintain a high degree of personal cleanliness. Suitable facilities must be available
near the place of milking to enable persons performing milking and handling raw milk to wash their hands and
arms.

III. CRITERIA FOR RAW MILK

1. The following criteria for raw milk apply pending the establishment of standards in the context of more specific

legislation on the quality of milk and dairy products.

2. A representative number of samples of raw milk collected from milk production holdings taken by random sampling

must be checked for compliance with points 3 and 4.

The checks may be carried out by, or on behalf of:

(a) the food business operator producing the milk;

(b) the food business operator collecting or processing the milk;

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(c) a group of food business operators; or

(d) in the context of a national or regional control scheme.

3. (a) Food business operators must initiate procedures to ensure that raw milk meets the following criteria:

(i) for raw cows' milk:

Plate count at 30 °C (per ml)

Somatic cell count (per ml)

£ 100 000 (*)

£ 400 000 (**)

(ii) for raw milk from other species:

Plate count at 30 °C (per ml)

£ 1 500 000 (*)

(b) However, if raw milk from species other than cows is intended for the manufacture of products made with raw
milk by a process that does not involve any heat treatment, food business operators must take steps to ensure
that the raw milk used meets the following criterion.

Plate count at 30 °C (per ml)

£ 500 000 (*)

4. Without prejudice to Directive 96/23/EC, food business operators must initiate procedures to ensure that raw milk is

not placed on the market if either:

(a)

it contains antibiotic residues in a quantity that, in respect of any one of the substances referred to in Annexes I
and III to Regulation (EEC) No 2377/90 (1), exceeds the levels authorised under that Regulation; or

(b) the combined total of residues of antibiotic substances exceeds any maximum permitted value.

5. When raw milk fails to comply with point 3 or 4, the food business operator must inform the competent authority

and take measures to correct the situation.

CHAPTER II: REQUIREMENTS CONCERNING DAIRY PRODUCTS

I. TEMPERATURE REQUIREMENTS

1. Food business operators must ensure that, upon acceptance at a processing establishment, milk is quickly cooled to

not more than 6 °C and kept at that temperature until processed.

2. However, food business operators may keep milk at a higher temperature if:

(a) processing begins immediately after milking, or within 4 hours of acceptance at the processing establishment; or

(b) the competent authority authorises a higher temperature for technological reasons concerning the manufacture of

certain dairy products.

II. REQUIREMENTS FOR HEAT TREATMENT

1. When raw milk or dairy products undergo heat treatment, food business operators must ensure that this satisfies the

requirements of Regulation (EC) No . . ./2004 (2), Annex II, Chapter XI.

(*) Rolling geometric average over a two-month period, with at least two samples per month.
(**) Rolling geometric average over a three-month period, with at least one sample per month, unless the competent authority specifies

another methodology to take account of seasonal variations in production levels.

(1) Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum
residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 224, 18.8.1990, p. 1). Regulation as last
amended by Commission Regulation (EC) No 665/2003 (OJ L 96, 12.4.2003, p. 7).

(2) See page 1 of this Official Journal.

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2. When considering whether to subject raw milk to heat treatment, food business operators must:

(a) have regard to the procedures developed in accordance with the HACCP principles pursuant to Regulation (EC)

No . . ./2004 (1); and

(b) comply with any requirements that the competent authority may impose in this regard when approving estab-

lishments or carrying out checks in accordance with Regulation (EC) No . . ./2004 (2).

III. CRITERIA FOR RAW COWS' MILK

1. Food business operators manufacturing dairy products must initiate procedures to ensure that, immediately before

processing:

(a) raw cows' milk used to prepare dairy products has a plate count at 30 °C of less than 300 000 per ml; and

(b) processed cows' milk used to prepare dairy products has a plate count at 30 °C of less than 100 000 per ml.

2. When milk fails to meet the criteria laid down in paragraph 1, the food business operator must inform the

competent authority and take measures to correct the situation.

CHAPTER III: WRAPPING AND PACKAGING

Sealing of consumer packages must be carried out immediately after filling in the establishment where the last heat
treatment of liquid dairy products takes place, by means of sealing devices that prevent contamination. 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

1. In addition to the requirements of Directive 2000/13/EC, except in the cases envisaged in Article 13(4) and (5) of

that Directive, labelling must clearly show:

(a)

in the case of raw milk intended for direct human consumption, the words ‘raw milk’;

(b) in the case of products made with raw milk, the manufacturing process for which does not include any heat

treatment or any physical or chemical treatment, the words ‘made with raw milk’.

2. The requirements of paragraph 1 apply to products destined for retail trade. The term ‘labelling’

includes any

packaging, document, notice, label, ring or collar accompanying or referring to such products.

CHAPTER V: IDENTIFICATION MARKING

By way of derogation from the requirements of Annex II, Section I:

1. rather than indicating the approval number of the establishment, the identification mark may include a reference to

where on the wrapping or packaging the approval number of the establishment is indicated;

2.

in the case of the reusable bottles, the identification mark may indicate only the initials of the consigning country
and the approval number of the establishment.

SECTION X: EGGS AND EGG PRODUCTS

CHAPTER I: EGGS

1. 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.

2. Eggs must be stored and transported at a temperature, preferably constant, that is best suited to assure optimal

conservation of their hygiene properties.

3. Eggs must be delivered to the consumer within a maximum time limit of 21 days of laying.

(1) See page 1 of this Official Journal.
(2) See page 82 of this Official Journal.

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CHAPTER II: EGG PRODUCTS

I. REQUIREMENTS FOR ESTABLISHMENTS

Food business operators must ensure that establishments for the manufacture of egg products are constructed, laid out
and equipped so as to ensure separation of the following operations:

1. washing, drying and disinfecting dirty eggs, where carried out;

2. breaking eggs, collecting their contents and removing parts of shells and membranes; and

3. operations other than those referred to in points 1 and 2.

II. RAW MATERIALS FOR THE MANUFACTURE OF EGG PRODUCTS

Food business operators must ensure that raw materials used to manufacture egg products comply with the following
requirements.

1. The shells of eggs used in the manufacture of egg products must be fully developed and contain no breaks. However,
cracked eggs may be used for the manufacture of egg products if the establishment of production or a packing centre
delivers them directly to a processing establishment, where they must be broken as soon as possible.

2. Liquid egg obtained in an establishment approved for that purpose may be used as raw material. Liquid egg must be

obtained in accordance with the requirements of points 1, 2, 3, 4 and 7 of Part III.

III. SPECIAL HYGIENE REQUIREMENTS FOR THE MANUFACTURE OF EGG PRODUCTS

Food business operators must ensure that all operations are carried out in such a way as to avoid any contamination
during production, handling and storage of egg products, in particular by ensuring compliance with the following
requirements.

1. Eggs must not be broken unless they are clean and dry.

2. Eggs must be broken in a manner that minimises contamination, in particular by ensuring adequate separation from

other operations. Cracked eggs must be processed as soon as possible.

3. Eggs other than those of hens, turkeys or guinea fowl must be handled and processed separately. All equipment must

be cleaned and disinfected before processing of hens', turkeys' and guinea fowls' eggs is resumed.

4. 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.

5. After breaking, each particle of the egg product must undergo processing as quickly as possible to eliminate
microbiological hazards or to reduce them to an acceptable level. A batch that has been insufficiently processed
may immediately undergo processing again in the same establishment, if this processing renders it fit for human
consumption. When a batch is found to be unfit for human consumption, it must be denatured so as to ensure that
it is not used for human consumption.

6. Processing is not required for egg white intended for the manufacture of dried or crystallised albumin destined

subsequently to undergo heat treatment.

7. If processing is not carried out immediately after breaking,

liquid egg must be stored either frozen or at a
temperature of not more than 4 °C. The storage period before processing at 4 °C must not exceed 48 hours.
However, these requirements do not apply to products to be de-sugared, if de-sugaring process is performed as
soon as possible.

8. Products that have not been stabilised so as to be kept at room temperature must be cooled to not more than 4 °C.

Products for freezing must be frozen immediately after processing.

IV. ANALYTICAL SPECIFICATIONS

1. The concentration of 3-OH-butyric acid must not exceed 10 mg/kg in the dry matter of the unmodified egg product.

2. The lactic acid content of raw material used to manufacture egg products must not exceed 1 g/kg of dry matter.

However, for fermented products, this value must be the one recorded before the fermentation process.

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3. The quantity of eggshell remains, egg membranes and any other particles in the processed egg product must not

exceed 100 mg/kg of egg product.

V. LABELLING AND IDENTIFICATION MARKING

1. In addition to the general requirements for identification marking laid down in Annex II, Section I, consignments of
egg products, destined not for retail but for use as an ingredient in the manufacture of another product, must have a
label giving the temperature at which the egg products must be maintained and the period during which conser-
vation may thus be assured.

2. In the case of liquid eggs, the label referred to in paragraph 1 must also bear the words:
products — to be treated at place of destination’ and indicate the date and hour of breaking.

‘non-pasteurised egg

SECTION XI: FROGS' LEGS AND SNAILS

Food business operators preparing frogs'
following requirements.

legs or snails for human consumption must ensure compliance with the

1. Frogs and snails must be killed in an establishment constructed, laid out and equipped for that purpose.

2. Establishment in which frogs' legs are prepared must have a room 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.

3. Frogs and snails that die otherwise than by being killed in the establishment must not be prepared for human

consumption.

4. Frogs and snails must be subjected to an organoleptic examination carried out by sampling. If that examination

indicates that they might present a hazard, they must not be used for human consumption.

5. Immediately following preparation, frogs' legs must be washed fully with running potable water and immediately

chilled to a temperature approaching that of melting ice, frozen or processed.

6. After killing, snails' hepato-pancreas must, if it might present a hazard, be removed and not be used for human

consumption.

SECTION XII: RENDERED ANIMAL FATS AND GREAVES

CHAPTER I: REQUIREMENTS APPLICABLE TO ESTABLISHMENTS COLLECTING OR PROCESSING RAW MATERIALS

Food business operators must ensure that establishments collecting or processing raw materials for the production of
rendered animal fats and greaves comply with the following requirements.

1. Centres for the collection of raw materials and further transport to processing establishments must be equipped with

facilities for the storage of raw materials at a temperature of not more than 7 °C.

2. Each processing establishment must have:

(a) refrigeration facilities;

(b) a dispatch room, unless the establishment dispatches rendered animal fat only in tankers; and

(c)

if appropriate, suitable equipment for the preparation of products consisting of rendered animal fats mixed with
other foodstuffs and/or seasonings.

3. However, the refrigeration facilities required under points 1 and 2(a) are not necessary if the arrangements for the
supply of raw materials ensure that they are never stored or transported without active refrigeration otherwise than
as provided for in Chapter II, point 1(d).

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CHAPTER II: HYGIENE REQUIREMENTS FOR THE PREPARATION OF RENDERED ANIMAL FAT AND GREAVES

Food business operators preparing rendered animal fats and greaves must ensure compliance with the following
requirements.

1. Raw materials must:

(a) derive from animals which have been slaughtered in a slaughterhouse, and which have been found fit for human

consumption following ante-mortem and post-mortem inspection;

(b) consist of adipose tissues or bones, which are reasonably free from blood and impurities;

(c) come from establishments registered or approved under Regulation (EC) No . . ./2004 (1) or under this Regu-

lation; and

(d) be transported, and stored until rendering, in hygienic conditions and at an internal temperature of not more
than 7 °C. However, raw materials may be stored and transported without active refrigeration if rendered within
12 hours after the day on which they were obtained.

2. During rendering the use of solvents is prohibited.

3. When the fat for refining meets the standards laid down in point 4, rendered animal fat prepared in accordance with
points 1 and 2 may be refined in the same establishment or in another establishment with a view to improving its
physico-chemical quality.

4. Rendered animal fat, depending on type, must meet the following standards:

Ruminants

Porcine animals

Other animal fat

Edible tallow

Edible fat

Premier
jus (1)

Other

Tallow for
refining

Lard (2)

Other

Lard and
other fat
for refining

Edible

For refining

FFA (m/m % oleic
maximum

acid)

0,75

1,25

3,0

0,75

1,25

2,0

1,25

3,0

Peroxide maximum

4 meq/kg 4 meq/kg 6 meq/kg 4 meq/kg 4 meq/kg 6 meq/kg 4 meq/kg 10 meq/kg

Total insoluble impurities

Maximum 0,15 %

Maximum 0,5 %

Odour, taste, colour

Normal

(1) 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.

(2) Rendered animal fat obtained from the adipose tissues of porcine animals.

5. Greaves

intended for human consumption must be stored in accordance with the following temperature

requirements.

(a) When greaves are rendered at a temperature of not more than 70 °C, they must be stored:

(i) at a temperature of not more than 7 °C for a period not exceeding 24 hours; or

(ii) at a temperature of not more than – 18 °C.

(b) When greaves are rendered at a temperature of more than 70 °C and have a moisture content of 10 % (m/m) or

more, they must be stored:

(i) at a temperature of not more than 7 °C for a period not exceeding 48 hours or a time/temperature ratio

giving an equivalent guarantee; or

(ii) at a temperature of not more than – 18 °C.

(c) When greaves are rendered at a temperature of more than 70 °C and have a moisture content of less than 10 %

(m/m), there are no specific requirements.

(1) See page 1 of this Official Journal.

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SECTION XIII: TREATED STOMACHS, BLADDERS AND INTESTINES

Food business operators treating stomachs, bladders and intestines must ensure compliance with the following
requirements.

1. Animal intestines, bladders and stomachs may be placed on the market only if:

(a) they derive from animals which have been slaughtered in a slaughterhouse, and which have been found fit for

human consumption following ante-mortem and post-mortem inspection;

(b) they are salted, heated or dried; and

(c) after the treatment referred to in (b), effective measures are taken to prevent re-contamination.

2. Treated stomachs, bladders and intestines that cannot be kept at ambient temperature must be stored chilled using
facilities intended for that purpose until their dispatch. In particular, products that are not salted or dried must be
kept at a temperature of not more than 3 °C.

SECTION XIV: GELATINE

1. Food business operators manufacturing gelatine must ensure compliance with the requirements of this Section.

2. For the purpose of this Section, ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium
salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic
hardening agents.

CHAPTER I: REQUIREMENTS FOR RAW MATERIALS

1. For the production of gelatine intended for use in food, the following raw materials may be used:

(a) bones;

(b) hides and skins of farmed ruminant animals;

(c) pig skins;

(d) poultry skin;

(e)

tendons and sinews;

(f) wild game hides and skins; and

(g) fish skin and bones.

2. The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this

process was completed.

3. Raw materials listed in point 1(a) to (e) must derive from animals which have been slaughtered in a slaughterhouse
and whose carcases have been found fit for human consumption following ante-mortem and post-mortem inspection
or, in the case of hides and skins from wild game, found fit for human consumption.

4. Raw materials must come from establishments registered or approved under Regulation (EC) No . . ./2004 (1) or

under this Regulation.

5. Collection centres and tanneries may also supply raw material for the production of gelatine intended for human
consumption if the competent authority specifically authorises them for this purpose and they fulfil the following
requirements.

(a) They must have storage rooms with hard floors and smooth walls that are easy to clean and disinfect and, where

appropriate, provided with refrigeration facilities.

(1) See page 1 of this Official Journal.

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(b) 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.

(c)

If raw material not in conformity with this Chapter is stored and/or processed in these premises, it must be
the period of receipt, storage,
in conformity with this Chapter throughout
segregated from raw material
processing and dispatch.

CHAPTER II: TRANSPORT AND STORAGE OF RAW MATERIALS

1. In place of the identification mark provided for in Annex II, Section I, a document indicating the establishment of
origin and containing the information set out in the Appendix to this Annex must accompany raw materials during
transport, when delivered to a collection centre or tannery and when delivered to the gelatine-processing estab-
lishment.

2. 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.

CHAPTER III: REQUIREMENTS FOR THE MANUFACTURE OF GELATINE

1. The production process for gelatine must ensure that:

(a) all ruminant bone material derived from animals born, reared or slaughtered in countries or regions classified as
having a low incidence of BSE 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 any approved equivalent process; and

(b) other raw material 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. If a food business operator manufacturing gelatine complies with the requirements applying to gelatine intended for
human consumption in respect of all the gelatine that it produces, it may produce and store gelatine not intended for
human consumption in the same establishment.

CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS

Food business operators must ensure that gelatine complies with the residue limits set out in the following table:

Residue

As

Pb

Cd

Hg

Cr

Cu

Zn

SO2 (Reith Williams)

H2O2 (European Pharmacopoeia 1986 (V2O2))

Limit

1 ppm

5 ppm

0,5 ppm

0,15 ppm

10 ppm

30 ppm

50 ppm

50 ppm

10 ppm

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1. Food business operators manufacturing collagen must ensure compliance with the requirements of this Section.

SECTION XV: COLLAGEN

2. For the purpose of this Section, ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium
salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic
hardening agents.

CHAPTER I: REQUIREMENTS FOR RAW MATERIALS

1. For the production of collagen intended for use in food, the following raw materials may be used:

(a) hides and skins of farmed ruminant animals;

(b) pig skins and bones;

(c) poultry skin and bones;

(d) tendons;

(e) wild game hides and skins; and

(f)

fish skin and bones.

2. The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this

process was completed.

3. Raw materials listed in point 1(a) to (d) must derive 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 hides and skins from wild game, found fit for human consumption.

4. Raw materials must come from establishments registered or approved under Regulation (EC) No . . ./2004 (1) or

under this Regulation.

5. Collection centres and tanneries may also supply raw material for the production of collagen intended for human
consumption if the competent authority specifically authorises them for this purpose and they fulfil the following
requirements.

(a) They must have storage rooms with hard floors and smooth walls that are easy to clean and disinfect and, where

appropriate, provided with refrigeration facilities.

(b) 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.

(c)

If raw material not in conformity with this Chapter is stored and/or processed in these premises, it must be
segregated from raw material
the period of receipt, storage,
in conformity with this Chapter throughout
processing and dispatch.

CHAPTER II: TRANSPORT AND STORAGE OF RAW MATERIALS

1. In place of the identification mark provided for in Annex II, Section I, a document indicating the establishment of
origin and containing the information set out in the Appendix to this Annex must accompany raw materials during
transport, when delivered to a collection centre or tannery and when delivered to the collagen-processing estab-
lishment.

2. 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.

(1) See page 1 of this Official Journal.

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CHAPTER III: REQUIREMENTS FOR THE MANUFACTURE OF COLLAGEN

1. Collagen must be produced by a process that ensures that the raw material is subjected to a treatment involving
washing, pH adjustment using acid or alkali followed by one or more rinses, filtration and extrusion or by an
approved equivalent process.

2. After having been subjected to the process referred to in paragraph 1 above, collagen may undergo a drying process.

3. If a food business operator manufacturing collagen complies with the requirements applying to collagen intended for
human consumption in respect of all the collagen that it produces, it may produce and store collagen not intended
for human consumption in the same establishment.

CHAPTER IV: REQUIREMENTS FOR FINISHED PRODUCTS

Food business operators must ensure that collagen complies with the residue limits set out in the following table:

Residue

As

Pb

Cd

Hg

Cr

Cu

Zn

SO2 (Reith Williams)

H2O2 (European Pharmacopoeia 1986 (V2O2))

CHAPTER V: LABELLING

Limit

1 ppm

5 ppm

0,5 ppm

0,15 ppm

10 ppm

30 ppm

50 ppm

50 ppm

10 ppm

Wrapping and packaging containing collagen must bear the words ‘collagen fit for human consumption’ and indicate
the date of preparation.

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MODEL DOCUMENT TO ACCOMPANY RAW MATERIAL DESTINED FOR THE PRODUCTION OF GELATINE OR
COLLAGEN

Appendix to Annex III

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STATEMENT OF THE COUNCIL'S REASONS

I.

INTRODUCTION

The Commission proposed a Regulation laying down specific hygiene rules for food of animal origin in
July 2000.

The European Parliament adopted an opinion on the proposed Regulation in May 2002.

The Economic and Social Committee adopted an opinion in March 2001 (1).

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

II. OBJECTIVE

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

The second Regulation would lay down specific hygiene rules for food business operators handling
food of animal origin. In particular, it would provide for:

— the approval of establishments;

— identification marking;

— specific requirements concerning imports; and

— flexibility for special cases.

III. ANALYSIS OF THE COMMON POSITION

A. Generalities

The common position incorporates many changes compared to the Commission's original proposal.
These are often consistent with the aims of amendments that the European Parliament proposed in
its first-reading opinion. The Commission has accepted the changes to its proposal.

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

— to ensure consistency with Regulation (EC) No 178/2002 (3);

— to ensure the overall coherence of the hygiene package (4);

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

principles from the Annexes to the Articles (5); and

— to clarify the text (6).

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

(3) These include changes consistent with the aims of EP amendments 1 to 4, 6, 14, 111 and 120.
(4) These include changes consistent with the aims of EP amendments 20, 23 and 47.
(5) These include changes consistent with the aims of EP amendments 11, 12, 22, 24 to 27, 30, 32, 43, 52, 56, 62, 67

and 128.

(6) These include changes consistent with the aims of EP amendments 16, 18, 19, 42, 45, 49, 83, 84 and 117.

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It also contains a number of technical amendments consistent with the overall objectives of the
Regulation stated in Section II above (1).

B. Scope (Article 1)

The Council agrees that it is not appropriate for Community legislation to lay down hygiene rules
for the direct supply of small quantities of certain products of animal origin to the final consumer
and local retail establishments.

The common position therefore contains provisions on the direct supply of small quantities of
primary products identical to those in the common position on the first hygiene Regulation. It
would also exclude the direct supply of small quantities of wild game, wild game meat or meat
from poultry and lagomorphs slaughtered on the farm from the scope of the Regulation (2).
However, it would make clear that:

— direct supply to local retail establishments covers only shops and — except in the case of
poultry and lagomorphs slaughtered on the farm — restaurants, but does not cover wholesale
or processing operations; and

— Member States must establish national rules for such direct supply and these rules must ensure

the achievement of the objectives of the Regulation.

The Council also agrees that the Regulation should not apply to composite products (that is, food
containing both products of plant origin and processed products of animal origin). The general rules
of the Regulation on the hygiene of foodstuffs are sufficient for such products (3).

The common position would make clear that composite products (but not products of animal
origin used to manufacture them) would fall outside the scope of the Regulation. However, the
Regulation would apply to food containing products of plant origin and unprocessed products of
animal origin. It would also apply to processed products of animal origin containing ingredients of
plant origin that are necessary for their manufacture or to give them specific characteristics.

The Council further agrees that the Regulation should not, as a general principle, apply to retail
activities, since the general rules of the first Regulation would suffice for the most part. However,
this general principle requires a degree of elaboration to ensure a proper balance between the
protection of public health and practical considerations.

The common position would consequently make clear that the general rule excluding retail from the
scope of the Regulation would not:

— affect specific provisions, when the Regulation explicitly states that they apply to retail

(for
example, the health standards and certain hygiene rules for live bivalve molluscs and fishery
products would apply to retail);

— cover wholesale activities (which could fall within the scope of the wide definition of ‘retail’ laid
down in Regulation (EC) No 178/2002), except in circumstances that avoid any undue risk for
public health;

— prevent Member States from applying stricter national rules to retail activities.

(1) These include changes consistent with the aims of EP amendments 34, 35, 37, 40, 46, 50, 51, 54, 59, 60, 62 to 64,

66, 68, 70 to 76, 79, 80, 100, 103 to 109, 111 to 115, 118, 122 to 124, 133 and 134.
(2) The common position is therefore consistent with the aim of EP amendments 82, 97 and 129.
(3) The common position is therefore consistent with EP amendment 5.

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C. Comitology (Articles 2, 9, 10, 11 and 12)

The Council agrees that it should not generally be possible to amend the definitions laid down
under the Regulation through comitology. However, rather than including a long list of definitions
in the Articles, the common position would instead leave them in Annex I but prevent the
amendment of this Annex through comitology. To provide flexibility, it would make it possible
for Annexes II and III to contain technical definitions that could be amended through comi-
tology (1).

to supplement

The common position also provides for the adoption of transitional measures through comitology
and,
the criteria governing amendments to Annexes II and III, contains a
non-exhaustive list of circumstances in which amendments or implementing rules could be
adopted through comitology.

D. Approval of establishments (Article 4)

The Council agrees that
food business
operators' obligations concerning the registration and approval of establishments and that these
the Regulation on official
ought
controls (2).

to dovetail with competent authorities' obligations under

the Regulation should contain an Article setting out

In addition to providing for this, the common position would clarify that approval would not be a
requirement for establishments storing products of animal origin that do not require temperature-
controlled storage conditions. It would also make transitional arrangements for existing estab-
lishments.

E. Health and identification marking (Article 5 and Annex II, Section I)

The Council does not accept that all meat should receive a health mark (3). The health mark should
be applied only in slaughterhouses and only to carcasses and part-carcasses of red meat, to reflect
the special role that the official veterinarian plays in such cases. All other meat, and all other
products of animal origin handled in approved establishments, ought instead to bear an identifi-
cation mark. The common position primarily provides for this by means of cross-references to the
Regulation on official controls, which would lay down rules on health marking.

The common position would make clear that the specific requirements on identification marking do
not affect food business operators' general duty to put in place systems and procedures to ensure
traceability. It would avoid any unnecessary duplication of existing requirements for the labelling
and marking of eggs.

F.

Imports (Article 6)

To be consistent with the Regulation's focus on food business operators' obligations, the common
position does not contain procedural rules concerning imports. These appear in the common
position on the Regulation on official controls.

Consequently,
the remaining provisions deal solely with food business operators' obligations
concerning imports, principally by means of cross-references to the relevant Articles of the Regu-
lation on official controls (4).

G. Special guarantees (Article 8)

The Council agrees that the provisions on salmonella guarantees should appear in an Article. The
common position would also:

— limit the scope of such guarantees to those products of animal origin to which they currently
apply in relation to Finland and Sweden, with the addition of minced poultry meat (which is not
currently in free circulation within the Community);

(1) The common position is therefore consistent with the aim of EP amendment 6.
(2) The common position is therefore consistent with the aim of EP amendments 7, 57, 77, 98, 102, 110 and 125.
(3) Consequently, the common position is not consistent with EP amendments 8 and 58.
(4) The common position is thus consistent with EP amendments 28 and 29.

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— provide flexibility to update the requirements for trade with Finland and Sweden;

— provide a mechanism for establishing similar temporary requirements in respect of trade with
other Member States with national control programmes exceeding the minimum Community
requirements concerning salmonella (1).

H. Flexibility (Article 10)

The Council agrees that an Article should provide flexibility for Member States to adopt national
measures adapting the detailed requirements laid down in Annex II, if this does not compromise
the objectives of the Regulation. It also agrees that it is appropriate to enhance the transparency of
the procedure through which Member States would exercise this flexibility, to ensure that all
envisaged measures undergo a proper review. The common position therefore contains provisions
identical to those in the common position on the Regulation on the hygiene of foodstuffs (2).

A recital would make clear that the structural and hygiene requirements laid down in the Regu-
lation would apply to all types of establishments, including small businesses and mobile slaughter-
houses. The general provisions on flexibility mean that there is no need to have a specific reference
to mobile slaughterhouses in the body of the Regulation (3).

The common position would also make clear that Member States could maintain or establish
appropriate health measures concerning raw milk and raw cream intended for direct human
consumption.

I. Date of application (Article 18)

The Council agrees that the scale of the reform of food hygiene legislation requires there to be a
reasonable delay between adoption of the new rules and their application (4). It is also necessary to
ensure that all elements of the hygiene package take effect at the same time.

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

J. HACCP (Annex II, Section II)

The Regulation on the hygiene of foodstuffs contains general requirements on hazard analysis and
critical control points (HACCP). The Commission's proposal for the Regulation on official controls
specified key outcomes that the implementation of HACCP procedures in slaughterhouses should
achieve. To ensure the internal coherence of the different elements of the hygiene package, the
Council has moved the requirements for slaughterhouse operators to the Regulation laying down
specific hygiene rules for food of animal origin.

K. Food chain information (Annex II, Section III)

The common position includes requirements for slaughterhouse operators concerning food chain
information. These rules are necessary to complement the requirements for primary producers
under the Regulation on the hygiene of foodstuffs and for competent authorities under the Regu-
lation on official controls.

(1) The common position is therefore partially consistent with EP amendments 10 and 61.
(2) The common position is consistent with EP amendments 31 and 53 and with part of amendment 9.
(3) As a result, the common position is consistent with the aim of EP amendments 41 and 81.
(4) The common position is therefore consistent with the aim of EP amendment 15.

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The rules provide considerable flexibility to avoid unnecessary bureaucracy (1) and to reflect the fact
that this is a new system that it will be necessary to review and to adapt in the light of experience.

L. Emergency slaughter (Annex III, Section I, Chapter VI)

The common position would considerably strengthen the rules on emergency slaughter. It would, in
particular:

— limit the emergency slaughter procedure to animals that were healthy before suffering an

accident;

— provide for meat from animals having undergone emergency slaughter to bear a special mark;

— restrict the placing on the market of such meat to the Member State of slaughter (subject to

national rules, which may impose additional restrictions); and

— oblige food business operators to follow any requirements that the official veterinarian may

impose concerning the use of such meat.

M. Wild game (Annex III, Section IV)

The Council supports the introduction of minimum Community requirements for the training of
hunters. It agrees, however, that these requirements should apply to commercial hunters only, that
Member States need not organise the training themselves; and that the list of topics that training
should cover should be a recommendation only (2).

In addition to clarifying these points, the common position incorporates a number of changes
aimed at simplifying and clarifying the hygiene requirements for large and small wild game (3). In
particular, it clarifies which body parts must (and which need not) accompany the animal to the
game handling establishment for post-mortem inspection.

N. Minced meat, meat preparations and MSM (Annex III, Section V)

Regulation (EC) No 999/2001 bans the use of certain ruminant material to produce mechanically
separated meat (MSM) to prevent the spread of transmissible spongiform encephalopathies. The
Council does not believe that it would be desirable or appropriate to repeat this ban. It is clear from
Article 1 that it takes precedence over the rules of the Regulation (4).

The common position would establish general requirements for raw material used to manufacture
meat preparations. These are sufficiently flexible to make it unnecessary to provide for national
derogations.

The common position would set differential rules for the production and use of MSM, depending
on the nature of the manufacturing process. Modern manufacturing methods do not alter the
structure of the bones used as raw material and produce MSM with a calcium content not
significantly higher than that of minced meat.

(1) The common position is therefore consistent with the aim of EP amendments 47 to 51 on the Regulation on official

controls.

(2) The common position is therefore consistent with the aim of EP amendments 83 and 84.
(3) The common position is therefore consistent with the aim of EP amendments 85 to 90, 92 to 96 and 132.
(4) Consequently, the common position is consistent with only part of EP amendment 107.

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Simplified requirements would apply to MSM manufactured using such modern methods. It would
be possible to use such MSM in meat preparations, under certain conditions. Stricter requirements
would apply to MSM manufactured using more intensive methods.

Member States would have the option of imposing labelling requirements on products that are
not currently in free circulation within the single market, to enable consumers to make an informed
choice.

O. Milk and dairy products (Annex III, Section IX)

The common position would simplify the requirements for heat-treated milk.

There would be no reference to commercial standards for heat-treated milk (such as pasteurisation).
Instead, the Regulation would simply lay down the hygiene requirements necessary to safeguard
the general
public health,
requirements of the Regulation on the hygiene of foodstuffs.

including specific requirements for heat-treatment

to supplement

The common position also makes clear that ‘raw milk’ does not include milk that has been heated
to more than 40 °C or undergone any treatment that has an equivalent effect (1).

P. Gelatine and collagen (Annex III, Sections XIV and XV)

The common position would maintain the current requirement for a document to accompany raw
materials destined for the production of gelatine during transport. This is desirable to ensure
traceability in a sector that
involves both food businesses and undertakings manufacturing
technical products from animal by-products. It would not lay down any quality requirements for
gelatine, since these are not appropriate in a Regulation on food hygiene.

The common position also incorporates rules on collagen derived from the rules that Commission
Decision 2003/42/EC added to Directive 92/118/EEC.

Q. Other

The common position would require the Commission:

— to consult EFSA when necessary; and

— to report on the implementation of the Regulation after five years (2).

The common position does not reflect those of the Parliament's amendments that the Commission
was not able to accept (3).

IV. CONCLUSION

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

(1) Consequently, the common position is consistent with the objective of EP amendment 21.
(2) The common position is therefore partially consistent with EP amendment 13.
(3) Amendments 8, 17, 33, 38, 44, 55, 58, 65, 69, 101 and 116.