Common Position (EC) No 1/2004 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 on the hygiene of foodstuffs
Date: 2003-10-27
Institutions: Council of the European Union
Subjects: EC Regulation, common position, food hygiene, food safety, foodstuff, foodstuffs legislation

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I

(Information)

COUNCIL

COMMON POSITION (EC) No 1/2004

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 . . . on the hygiene of foodstuffs

(2004/C 48 E/01)

THE EUROPEAN PARLIAMENT AND
THE COUNCIL OF THE EUROPEAN UNION,

(2) Council Directive 93/43/EEC of 14 June 1993 on the
hygiene of foodstuffs (5)
laid down the general rules of
hygiene for foodstuffs and the procedures for verification
of compliance with these rules.

Having regard to the Treaty establishing the European
Community, and in particular Articles 95 and 152(4)(b)
thereof,

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

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

After consulting the Committee of the Regions,

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

Whereas:

(3) Experience has shown that

the

these rules and procedures
constitute a sound basis for ensuring food safety. In the
context of
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 and procedures
contain common principles, in particular in relation to the
manufacturers' and competent authorities' responsibilities,
structural, operational and hygiene requirements for estab-
lishments, procedures for the approval of establishments,
requirements for storage and transport and health marks.

(1) The pursuit of a high level of protection of human life and
health is one of the fundamental objectives of food law, as
laid down in Regulation (EC) No 178/2002 (4). That Regu-
lation also lays down other common principles and defi-
nitions for national and Community food law, including
the aim of achieving free movement of food within the
Community.

(6)

(1) OJ C 365 E, 19.12.2000, p. 43.
(2) OJ C 155, 29.5.2001, p. 39.
(3) Opinion of the European Parliament of 15 May 2002 (OJ C 180 E
of 31.7.2003, p. 267), Council Common Position of 27 October
2003 and Position of the European Parliament of . . .
(not yet
published in the Official Journal).

(4) 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).

(5) These principles constitute a common basis

hygienic production of all
animal origin listed in Annex I to the Treaty.

food,

the
including products of

for

In addition to this common basis, specific hygiene rules
are necessary for certain foodstuffs. Regulation (EC)
No . . ./2004 of
the
Council of
laying down specific hygiene rules for
food of animal origin (6) lays down these rules.

the European Parliament and of

. . .,

(7) The principal objective of the new general and specific
hygiene rules is to ensure a high level of consumer
protection with regard to food safety.

(5) OJ L 175, 19.7.1993, p. 1.
(6) See page 23 of this Official Journal.

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(8) An integrated approach is necessary to ensure food safety
from the place of primary production up to and including
placing on the market or export. Every food business
operator along the food chain should ensure that food
safety is not compromised.

(14) While the requirement of establishing procedures based on
the HACCP principles should not initially apply to primary
production, the feasibility of
its extension will be one
element of the review that
the Commission will carry
out following implementation of this Regulation.

(9) Community rules should not apply either to primary
production for private domestic use, or to the domestic
food for private
preparation, handling or
domestic consumption. Moreover,
they should apply
the concept of which implies a
only to undertakings,
certain continuity of activities and a certain degree of
organisation.

storage of

in the case of

the objectives of
the direct

(10) Food hazards present at the level of primary production
should be identified and adequately controlled to ensure
the achievement of
this Regulation.
supply of small
However,
quantities of primary products, by the food business
operator producing them, to the final consumer or to a
local retail establishment,
is appropriate to protect
it
public health through national law, in particular because
of the close relationship between the producer and the
consumer.

(11) The application of hazard analysis and critical control
point (HACCP) principles to primary production is not
yet generally feasible. However, guides to good practice
should encourage
appropriate hygiene
the use of
practices at farm level. Where necessary, specific hygiene
rules for primary production should supplement
these
is appropriate for the hygiene requirements
guides.
It
associated
production
applicable
operations to differ from those for other operations.

primary

and

to

(12) Food safety is a result of several factors: legislation should
lay down minimum hygiene requirements; official controls
should be in place to check food business operators'
compliance and food business operators should establish
and operate food safety programmes and procedures based
on the HACCP principles.

(13) Successful implementation of the procedures based on the
HACCP principles will require the full cooperation and
food business employees. To this end,
commitment of
employees should undergo training. The HACCP system
is an instrument to help food business operators attain a
higher standard of food safety. The HACCP system should
not be regarded as a method of self-regulation and should
not replace official controls.

sufficient

applicable

(15) The HACCP requirements should take account of the prin-
ciples contained in the Codex Alimentarius. They should
provide
in all
flexibility to be
it
situations, including in small businesses. In particular,
is necessary to recognise that, in certain food businesses, it
is not possible to identify critical control points and that,
in some cases, good hygienic practices can replace the
the
monitoring of
requirement of establishing ‘critical limits’ does not imply
that it is necessary to fix a numerical limit in every case. In
addition, the requirement of retaining documents needs to
be flexible in order to avoid undue burdens for very small
businesses.

control points. Similarly,

critical

for regions that are subject

referred to in Article 299(2) of
should

(16) Flexibility is also 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
food
However,
hygiene objectives. Moreover, since all food produced in
accordance with the hygiene rules will be in free circu-
lation throughout the Community, the procedure allowing
Member States to exercise flexibility should be fully trans-
It should provide, where necessary to resolve
parent.
disagreements,
Standing
Committee on the Food Chain and Animal Health estab-
lished by Regulation (EC) No 178/2002.

discussion within

compromise

flexibility

not

the

for

or

guide

performance

standards may

(17) The setting of objectives such as pathogen reduction
targets
the
implementation of hygiene rules. It is therefore necessary
to provide procedures for that purpose. Such objectives
would supplement existing food law, such as Council
Regulation (EEC) No 315/93 of 8 February 1993 laying
down Community procedures for contaminants in food (1),
which provides
establishment of maximum
tolerances for specific contaminants, and Regulation (EC)
No 178/2002, which prohibits the placing on the market
of unsafe food and provides a uniform basis for the use of
the precautionary principle.

the

for

(1) OJ L 37, 13.2.1993, p. 1.

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(18) 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. This
Regulation takes account of international obligations laid
down in the WTO Sanitary and Phytosanitary Agreement
and the international food safety standards contained in
the Codex Alimentarius.

(26) The measures necessary for the implementation of this
Regulation should be
adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (1),

HAVE ADOPTED THIS REGULATION:

(19) The registration of establishments and the cooperation of
food business operators are necessary to allow the
controls
competent
efficiently.

perform official

authorities

to

(20) The traceability of food and food ingredients along the
food chain is an essential element
in ensuring food
safety. Regulation (EC) No 178/2002 contains rules to
ensure the traceability of food and food ingredients and
provides a procedure for the adoption of implementing
rules to apply these principles in respect of specific
sectors.

requirements

(21) Food imported into the Community is to comply with the
laid down in Regulation (EC)
general
No 178/2002 or satisfy rules that are equivalent
to
Community rules. The present Regulation defines certain
specific hygiene requirements for food imported into the
Community.

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

This Regulation lays down general rules for food business
taking particular

1.
operators on the hygiene of
account of the following principles:

foodstuffs,

(a) primary responsibility for food safety rests with the food

business operator;

(b) it is necessary to ensure food safety throughout the food

chain, starting with primary production;

(c)

it is important, for food that cannot be stored safely at
ambient
to
temperatures,
maintain the cold chain;

particularly

frozen

food,

(22) Food exported to third countries from the Community is
to comply with the general requirements laid down in
Regulation (EC) No 178/2002. The present Regulation
defines certain specific hygiene requirements for food
exported from the Community.

(d) general implementation of procedures based on the HACCP
principles, together with the application of good hygiene
practice, should reinforce food business operators' respon-
sibility;

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

(e) guides to good practice are a valuable instrument to aid
food business operators at all levels of the food chain with
compliance with food hygiene
and with the
application of the HACCP principles;

rules

(24) Since this Regulation replaces Directive 93/43/EEC, the

latter should be repealed.

(f)

it
is necessary to establish microbiological criteria and
temperature control requirements based on a scientific
risk assessment;

(25) 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
affected industries time to adapt.

the new rules,

(g)

it is necessary to ensure that imported foods are of at least
the same hygiene standard as
food produced in the
Community, or are of an equivalent standard.

(1) OJ L 184, 17.7.1999, p. 23.

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stages of production,
This Regulation shall apply to all
processing and distribution of
food and to exports, and
without prejudice to more specific requirements relating to
food hygiene.

2.

This Regulation shall not apply to:

(a) primary production for private domestic use;

(f)

(g)

‘potable water’ means water meeting the minimum
requirements laid down in Council Directive 98/83/EC of
3 November 1998 on the quality of water intended for
human consumption (1);

‘clean seawater’ means natural,
artificial or purified
seawater or brackish water that does not contain micro-
organisms, harmful substances or toxic marine plankton in
quantities capable of directly or indirectly affecting the
health quality of food;

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

private domestic consumption;

(h)

‘clean water’ means clean seawater and fresh water of a
similar quality;

(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;

(d) collection centres and tanneries which fall within the defi-
food business only because they handle raw

nition of
material for the production of gelatine or collagen.

(i)

(j)

‘wrapping’ means the placing of a foodstuff in a wrapper
or
foodstuff
contact with the
concerned, and the wrapper or container itself;

in direct

container

‘packaging’ means the placing of one or more wrapped
foodstuffs in a second container, and the latter container
itself;

3. Member States shall establish, under national law, rules
governing the activities referred to in paragraph 2(c). Such
national rules shall ensure the achievement of the objectives
of this Regulation.

(k)

‘hermetically sealed container’ means a container that is
designed and intended to be secure against the entry of
hazards;

Article 2

Definitions

1.

For the purposes of this Regulation:

(l)

‘processing’ means any action that substantially alters the
initial product,
curing,
including heating,
maturing, drying, marinating, extraction, extrusion or a
combination of those processes;

smoking,

(a)

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

(m) ‘unprocessed products’ means foodstuffs that have not
undergone processing, and includes products that have
been divided, parted,
sliced, boned, minced,
severed,
skinned, ground, cut, cleaned, trimmed, husked, milled,
chilled, frozen, deep-frozen or thawed;

(b)

‘establishment’ means any unit of a food business;

(n)

(c)

‘competent authority’ means the central authority of a
Member State competent to ensure compliance with the
requirements of this Regulation or any other authority to
which
that
authority
competence; it shall also include, where appropriate, the
corresponding authority of a third country;

delegated

central

that

has

‘processed products’ means foodstuffs resulting from the
processing of unprocessed products. These products may
contain ingredients that are necessary for their manu-
facture or to give them specific characteristics.

The

2.
No 178/2002 shall also apply.

definitions

laid

down

in

Regulation

(EC)

(d)

‘equivalent’ means, in respect of different systems, capable
of meeting the same objectives;

‘where appropriate’,

3.
In the Annexes to this Regulation the terms ‘where
necessary’,
‘adequate’ and ‘sufficient’ shall
appropriate,
mean respectively where necessary, where
adequate or sufficient to achieve the objectives of this Regu-
lation.

(e)

‘contamination’ means the presence or introduction of a
hazard;

(1) OJ L 330, 5.12.1998, p. 32.

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CHAPTER II

FOOD BUSINESS OPERATORS' OBLIGATIONS

Food business operators may use the guides provided for
6.
in Articles 7, 8 and 9 as an aid to compliance with their
obligations under this Regulation.

Article 3

General obligation

Food business operators
stages of
production, processing and distribution of food under their
control satisfy the relevant hygiene requirements laid down
in this Regulation.

shall ensure

that all

Article 4

General and specific hygiene requirements

1.
Food business operators carrying out primary production
and those associated operations listed in Annex I shall comply
with the general hygiene provisions laid down in Part A of
Annex I and any specific requirements provided for in Regu-
lation (EC) No . . ./2004 (1).

Food business operators carrying out any stage of
2.
production, processing and distribution of
food after those
stages to which paragraph 1 applies shall comply with the
general hygiene requirements laid down in Annex II and any
specific
in Regulation (EC)
No . . ./2004.

requirements provided

for

3.

Food business operators shall:

(a) comply with microbiological criteria and temperature

control requirements; and

(b) take measures or adopt procedures necessary to meet
targets set to achieve the objectives of this Regulation.

4.
The criteria,
paragraph 3 shall be
procedure referred to in Article 14(2).

requirements and targets referred to in
adopted in accordance with the

Associated sampling and analysis methods shall be laid down
in accordance with the same procedure.

5. When this Regulation, Regulation (EC) No . . ./2004 and
their
implementing measures do not specify sampling or
analysis methods, food business operators may use appropriate
methods laid down in other Community or national legislation
or,
in the absence of such methods, methods that offer
to those obtained using the reference
equivalent
method, if they are scientifically validated in accordance with
internationally recognised rules or protocols.

results

(1) See page 23 of this Official Journal.

Article 5

Hazard analysis and critical control points

Food business operators shall put in place,

implement
1.
and maintain a permanent procedure or procedures based on
the HACCP principles.

The HACCP principles referred to in paragraph 1 consist

2.
of the following:

(a)

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

(b) identifying the critical control points at the step or steps at
which control is essential to prevent or eliminate a hazard
or to reduce it to acceptable levels;

(c) establishing critical

limits at critical control points which
separate
the
prevention, elimination or reduction of identified hazards;

from unacceptability

acceptability

for

(d) establishing

and

implementing

effective monitoring

procedures at critical control points;

(e) establishing corrective actions when monitoring indicates

that a critical control point is not under control;

(f) establishing procedures, which shall be

regularly,
that
subparagraphs (a) to (e) are working effectively; and

to verify

carried out
the measures outlined in

(g) establishing documents and records commensurate with the
nature and size of the food business to demonstrate the
effective
in
subparagraphs (a) to (f).

the measures

application

outlined

of

When any modification is made in the product, process, or any
step, food business operators shall review the procedure and
make the necessary changes to it.

Paragraph 1 shall apply only to food business operators
stage of production, processing and
food after primary production and those

3.
carrying out
distribution of
associated operations listed in Annex I.

any

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4.

Food business operators shall:

(a) provide the competent authority with evidence of their
the
compliance with paragraph 1 in the manner that
the
taking account of
competent
nature and size of the food business;

authority requires,

(b) ensure that any documents describing the procedures
developed in accordance with this Article are up-to-date
at all times;

(c) retain any other documents and records for an appropriate

period.

5.
this
Detailed arrangements for the implementation of
Article may be laid down in accordance with the procedure
referred to in Article 14(2). Such arrangements may facilitate
the implementation of this Article by certain food business
operators, in particular by providing for the use of procedures
set out in guides for the application of HACCP principles, in
order to comply with paragraph 1. Such arrangements may
also specify the period during which food business operators
shall
in accordance with
paragraph 4(c).

retain documents and records

Article 6

Official controls, registration and approval

Food business operators

1.
cooperate with the
competent authorities in accordance with other applicable
Community legislation or,
if it does not exist, with national
law.

shall

2.
In particular, every food business operator shall notify the
appropriate competent authority, in the manner that the latter
requires, of each establishment under its control that carries
out any of the stages of production, processing and distribution
of food, with a view to the registration of each such estab-
lishment.

Food business operators shall also ensure that the competent
authority always has up-to-date information on establishments,
including by notifying any significant change in activities and
any closure of an existing establishment.

3.
However, food business operators shall ensure that estab-
lishments are approved by the competent authority, following
at least one on-site visit, when approval is required:

(a) under the national law of the Member State in which the

establishment is located;

(b) under Regulation (EC) No . . ./2004; or

(c) by a decision adopted in accordance with the procedure

referred to in Article 14(2).

Any Member State requiring the approval of certain estab-
lishments located on its
law, as
provided for in subparagraph (a), shall inform the Commission
and other Member States of the relevant national rules.

territory under national

CHAPTER III

GUIDES TO GOOD PRACTICE

Article 7

Development, dissemination and use of guides

Member States shall encourage the development of national
guides to good practice for hygiene and for the application
of HACCP
8.
Community guides shall be developed in accordance with
Article 9.

accordance with Article

principles

in

The dissemination and use of both national and Community
guides
food business
encouraged. Nevertheless,
operators may use these guides on a voluntary basis.

shall be

Article 8

National guides

1. When national guides to good practice are developed,
they shall be developed and disseminated by food business
sectors:

(a)

in consultation with representatives of parties whose
interests may be substantially affected, such as competent
authorities and consumer groups;

(b) having regard to relevant codes of practice of the Codex

Alimentarius; and

(c) when they

concern primary production and those
associated operations listed in Annex I, having regard to
the recommendations set out in Part B of Annex I.

2.
National guides may be developed under the aegis of a
national standards institute referred to in Annex II to Directive
98/34/EC (1).

3. Member States shall assess national guides in order to
ensure that:

(a) they have been developed in accordance with paragraph 1;

(b) their contents are practicable for the sectors to which they

refer; and

(c)

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

(1) Directive 98/34/EC of the European Parliament and of the Council
of 22 June 1998 laying down a procedure for the provision of
information in the field of technical standards and regulations (OJ
L 204, 21.7.1998, p. 37). Directive as amended by Directive
98/48/EC (OJ L 217, 5.8.1998, p. 18).

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4. Member States shall forward to the Commission national
guides complying with the requirements of paragraph 3. The
Commission shall set up and run a registration system for such
guides and make it available to Member States.

The Commission shall invite the Committee referred to in
4.
Article 14 periodically to review any Community guides
prepared in accordance with this Article, in cooperation with
the bodies mentioned in paragraph 2.

Guides

5.
to good practice drawn up under Directive
93/43/EEC shall continue to apply after the entry into force
of this Regulation, provided that they are compatible with its
objectives.

The aim of this review shall be to ensure that the guides
remain practicable and to take account of technological and
scientific developments.

Article 9

Community guides

The titles and references of Community guides prepared
5.
in accordance with this Article shall be published in the C
series of the Official Journal of the European Union.

1.
Before Community guides to good practice for hygiene or
for the application of the HACCP principles are developed, the
Commission shall consult the Committee referred to in Article
14. The objective of this consultation shall be to consider the
case for such guides, their scope and subject matter.

2. When Community guides are prepared, the Commission
shall ensure that they are developed and disseminated:

(a) by or in consultation with appropriate representatives of
European food business sectors, including SMEs, and other
interested parties, such as consumer groups;

CHAPTER IV

IMPORTS AND EXPORTS

Article 10

Imports

regards

the hygiene of

the relevant
As
requirements of food law referred to in Article 11 of Regu-
lation (EC) No 178/2002 shall include the requirements laid
down in Articles 3 to 6 of this Regulation.

imported food,

(b) in collaboration with parties whose interests may be
substantially affected, including competent authorities;

Article 11

Exports

(c) having regard to relevant codes of practice of the Codex

Alimentarius; and

As regards the hygiene of exported or re-exported food, the
relevant requirements of food law referred to in Article 12 of
Regulation (EC) No 178/2002 shall include the requirements
laid down in Articles 3 to 6 of this Regulation.

(d) when they

concern primary production and those
associated operations listed in Annex I, having regard to
the recommendations set out in Part B of Annex I.

The Committee referred to in Article 14 shall assess draft

3.
Community guides in order to ensure that:

(a) they have been developed in accordance with paragraph 2;

CHAPTER V

FINAL PROVISIONS

Article 12

Implementing measures and transitional arrangements

Implementing measures and transitional arrangements may be
laid down in accordance with the procedure referred to in
Article 14(2).

(b) their contents are practicable for the sectors to which they

refer throughout the Community; and

Article 13

(c) they are suitable as guides to compliance with Articles 3, 4

and 5 in the sectors and for the foodstuffs covered.

Amendment and adaptation of Annexes I and II

1.
Annexes I and II may be repealed, amended, adapted or
supplemented, in accordance with the procedure referred to in
Article 14(2), to take account of:

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(a) the development of guides to good practice;

(d) give any other relevant information.

(b) the

experience

gained from the

implementation of

HACCP-based systems pursuant to Article 5;

(c) technological developments;

(d) scientific advice, particularly new risk assessments;

(e) the setting of food safety targets.

2.
Exemptions from Annexes I and II may be granted in
accordance with the procedure referred to in Article 14(2),
the
provided that
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 4 to 7 of this Article, national measures adapting
the requirements laid down in Annex II.

4.

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

have the aim of:

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

(ii) accommodating the needs of

that are subject

food businesses
to special

situated in regions
geographical constraints.

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 the 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 14(1). The
Commission may decide,
in accordance with the procedure
referred to in Article 14(2), whether the envisaged measures
to appropriate
may be implemented, subject,
amendments. Where
the Commission may
appropriate,
propose general measures in accordance with paragraph 1 or
2.

if necessary,

A Member State may adopt national measures adapting

7.
the requirements of Annex II only:

(a)

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

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

adoption of

the

Article 14

Committee procedure

The Commission shall be assisted by the Standing

1.
Committee on the Food Chain and Animal Health.

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

layout and equipment of establishments.

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

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

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

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

3.

The Committee shall adopt its rules of procedure.

(b) describe the foodstuffs and establishments concerned;

Article 15

Consultation of the European Food Safety Authority

(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

The Commission shall consult
the European Food Safety
Authority on any matter falling within the scope of this Regu-
lation that could have a significant impact on public health
and,
in particular, before proposing criteria, requirements or
targets in accordance with Article 4(4).

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Article 16

Report to the European Parliament and the Council

The Commission shall, not later than . . . (*), submit a

1.
report to the European Parliament and the Council.

The report shall,

2.
in particular, review the experience
gained from the application of this Regulation and consider
whether it would be desirable and practicable to provide for
the extension of the requirements of Article 5 to food business
operators carrying out primary production and those associated
operations listed in Annex I.

The Commission shall,

3.
report with relevant proposals.

if appropriate, accompany the

Pending the application of new Community legislation
4.
laying down rules for official controls on food, Member
States
to ensure the
fulfilment of the obligations laid down in or under this Regu-
lation.

take all appropriate measures

shall

Article 18

Entry into force

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

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

Article 17

Repeal

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

Directive 93/43/EEC shall be repealed with effect from

1.
the date of application of this Regulation.

References to the repealed Directive shall be construed as

2.
being made to this Regulation.

3.
However, decisions adopted pursuant to Articles 3(3) and
10 of Directive 93/43/EEC shall remain in force pending their
replacement by decisions adopted in accordance with this
Regulation or Regulation (EC) No 178/2002. Pending the
setting of the criteria or requirements referred to in Article
4(3)(a) of this Regulation, Member States may maintain any
national rules establishing such criteria or requirements that
they had adopted in accordance with Directive 93/43/EEC.

(b) Regulation (EC) No . . ./2004 of the European Parliament
and of the Council of . . ., laying down specific rules for the
organisation of official controls on products of animal
origin intended for human consumption (1); and

(c) Directive 2004/. . ./EC of the European Parliament and of
the Council of . . . repealing certain Directives concerning
food hygiene and health conditions for the production and
placing on the market of certain products of animal origin
intended for human consumption (2).

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

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

Done at . . .

For the European Parliament

The President

For the Council

The President

(*) Five years after the entry into force of this Regulation.

(1) See page 82 of this Official Journal.
(2) See page 131 of this Official Journal.

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ANNEX I

PRIMARY PRODUCTION

PART A: GENERAL HYGIENE PROVISIONS FOR PRIMARY PRODUCTION AND ASSOCIATED OPERATIONS

I. SCOPE

1. This Annex applies to primary production and the following associated operations:

(a) the transport, storage and handling of primary products at the place of production, provided that this does not

substantially alter their nature;

(b) the transport of live animals, where this is necessary to achieve the objectives of this Regulation; and

(c)

in the case of products of plant origin, fishery products and wild game, transport operations to deliver primary
products, the nature of which has not been substantially altered, from the place of production to an estab-
lishment.

II. HYGIENE PROVISIONS

2. As far as possible, food business operators are to ensure that primary products are protected against contamination,

having regard to any processing that primary products will subsequently undergo.

3. Notwithstanding the general duty laid down in paragraph 2, food business operators are to comply with appro-
priate Community and national legislative provisions relating to the control of hazards in primary production and
associated operations, including:

(a) measures to control contamination arising from the air, soil, water,

feed,

fertilisers, veterinary medicinal

products, plant protection products and biocides and the storage, handling and disposal of waste; and

(b) measures relating to animal health and welfare and plant health that have implications for human health,

including programmes for the monitoring and control of zoonoses and zoonotic agents.

4. Food business operators rearing, harvesting or hunting animals or producing primary products of animal origin are

to take adequate measures, as appropriate:

(a)

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

(b) to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, equipment, containers,

crates, vehicles and vessels;

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

animals;

(d) to use potable water, or clean water, whenever necessary to prevent contamination;

(e)

to ensure that staff handling foodstuffs are in good health and undergo training on health risks;

(f) as far as possible to prevent animals and pests from causing contamination;

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

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

(i)

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

(j)

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

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5. Food business operators producing or harvesting plant products are to take adequate measures, as appropriate:

(a)

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

(b) to ensure, where necessary, hygienic production, transport and storage conditions for, and the cleanliness of,

plant products;

(c)

to use potable water, or clean water, whenever necessary to prevent contamination;

(d) to ensure that staff handling foodstuffs are in good health and undergo training on health risks;

(e) as far as possible to prevent animals and pests from causing contamination;

(f)

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

(g) to take account of the results of any relevant analyses carried out on samples taken from plants or other

samples that have importance to human health; and

(h) to use plant protection products and biocides correctly, as required by the relevant legislation.

6. Food business operators are to take appropriate remedial action when informed of problems identified during

official controls.

III. RECORD-KEEPING

7. Food business operators are to keep and retain records relating to measures put in place to control hazards in an
appropriate manner and for an appropriate period, commensurate with the nature and size of the food business.
Food business operators are to make relevant information contained in these records available to the competent
authority and receiving food business operators on request.

8. Food business operators rearing animals or producing primary products of animal origin are, in particular, to keep

records on:

(a) the nature and origin of feed fed to the animals;

(b) veterinary medicinal products or other treatments administered to the animals, dates of administration and

withdrawal periods;

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

(d) the results of any analyses carried out on samples taken from animals or other samples taken for diagnostic

purposes, that have importance for human health; and

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

9. Food business operators producing or harvesting plant products are, in particular, to keep records on:

(a) any use of plant protection products and biocides;

(b) any occurrence of pests or diseases that may affect the safety of products of plant origin; and

(c) the results of any relevant analyses carried out on samples taken from plants or other samples that have

importance to human health.

10. The food business operators may be assisted by other persons, such as veterinarians, agronomists and farm tech-

nicians, with the keeping of records.

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PART B: RECOMMENDATIONS FOR GUIDES TO GOOD HYGIENE PRACTICE

1. National and Community guides referred to in Articles 7 to 9 of this Regulation should contain guidance on good

hygiene practice for the control of hazards in primary production and associated operations.

2. Guides to good hygiene practice should include appropriate information on hazards that may arise in primary
in
legislation or national and Community programmes. Examples of such hazards and

production and associated operations and actions to control hazards,
Community and national
measures may include:

including relevant measures set out

(a)

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

(b) the use of water, organic waste and fertilisers;

(c)

the correct and appropriate use of plant protection products and biocides and their traceability;

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

(e)

the preparation, storage, use and traceability of feed;

(f)

the proper disposal of dead animals, waste and litter;

(g) protective measures to prevent the introduction of contagious diseases transmissible to humans through food,

and any obligation to notify the competent authority;

(h) procedures, practices and methods to ensure that food is produced, handled, packed, stored and transported

under appropriate hygienic conditions, including effective cleaning and pest-control;

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

(j) measures relating to record-keeping.

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ANNEX II

GENERAL HYGIENE REQUIREMENTS FOR ALL FOOD BUSINESS OPERATORS

(EXCEPT WHEN ANNEX I APPLIES)

INTRODUCTION

Chapters V to XII apply to all stages of production, processing and distribution of food and the remaining Chapters
apply as follows:

— Chapter I applies to all food premises, except premises to which Chapter III applies;

— Chapter II applies to all rooms where food is prepared, treated or processed, except dining areas and premises to

which Chapter III applies;

— Chapter III applies to those premises listed in the heading to the Chapter;

— Chapter IV applies to all transportation.

GENERAL REQUIREMENTS FOR FOOD PREMISES (OTHER THAN THOSE SPECIFIED IN CHAPTER III)

1. Food premises are to be kept clean and maintained in good repair and condition.

CHAPTER I

2. The layout, design, construction, siting and size of food premises are to:

(a) permit adequate maintenance, cleaning and/or disinfection, avoid or minimise air-borne contamination, and

provide adequate working space to allow for the hygienic performance of all operations;

(b) be such as to protect against the accumulation of dirt, contact with toxic materials, the shedding of particles

into food and the formation of condensation or undesirable mould on surfaces;

(c) permit good food hygiene practices, including protection against contamination and, in particular, pest control;

and

(d) where necessary, provide suitable temperature-controlled handling and storage conditions of sufficient capacity
for maintaining foodstuffs at appropriate temperatures and designed to allow those temperatures to be
monitored and, where necessary, recorded.

3. An adequate number of flush lavatories are to be available and connected to an effective drainage system. Lavatories

are not to open directly into rooms in which food is handled.

4. An adequate number of washbasins is to be available, suitably located and designated for cleaning hands.
Washbasins for cleaning hands are to be provided with hot and cold running water, materials for cleaning
hands and for hygienic drying. Where necessary, the facilities for washing food are to be separate from the
hand-washing facility.

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

6. Sanitary conveniences are to have adequate natural or mechanical ventilation.

7. Food premises are to have adequate natural and/or artificial lighting.

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

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9. Where necessary, adequate changing facilities for personnel are to be provided.

10. Cleaning agents and disinfectants are not to be stored in areas where food is handled.

CHAPTER II

SPECIFIC REQUIREMENTS IN ROOMS WHERE FOODSTUFFS ARE PREPARED, TREATED OR PROCESSED
(EXCLUDING DINING AREAS AND THOSE PREMISES SPECIFIED IN CHAPTER III)

1. In rooms where food is prepared, treated or processed (excluding dining areas and those premises specified in
Chapter III, but including rooms contained in means of transport) the design and layout are to permit good food
hygiene practices, including protection against contamination between and during operations. In particular:

(a)

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

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

(c) ceilings (or, where there are no ceilings, the interior surface of the roof) and overhead fixtures are to be
constructed and finished so as to prevent the accumulation of dirt and to reduce condensation, the growth of
undesirable mould and the shedding of particles;

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

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

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

2. Adequate facilities are to be provided, where necessary, for the cleaning, disinfecting and storage of working utensils
and equipment. These facilities are to be constructed of corrosion-resistant materials, be easy to clean and have an
adequate supply of hot and cold water.

3. Adequate provision is to be made, where necessary, for washing food. Every sink or other such facility provided for
the washing of food is to have an adequate supply of hot and/or cold potable water consistent with the requirements
of Chapter VII and be kept clean and, where necessary, disinfected.

CHAPTER III

REQUIREMENTS FOR MOVABLE AND/OR TEMPORARY PREMISES (SUCH AS MARQUEES, MARKET STALLS,
MOBILE SALES VEHICLES), PREMISES USED PRIMARILY AS A PRIVATE DWELLING HOUSE BUT WHERE FOODS
ARE REGULARLY PREPARED FOR PLACING ON THE MARKET, AND VENDING MACHINES

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

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2. In particular, where necessary:

(a) appropriate facilities are to be available to maintain adequate personal hygiene (including facilities for the

hygienic washing and drying of hands, hygienic sanitary arrangements and changing facilities);

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

(c) adequate provision is to be made for the cleaning and, where necessary, disinfecting of working utensils and

equipment;

(d) where foodstuffs are cleaned as part of the food business' operations, adequate provision is to be made for this to

be undertaken hygienically;

(e) an adequate supply of hot and/or cold potable water is to be available;

(f) adequate arrangements and/or facilities for the hygienic storage and disposal of hazardous and/or inedible

substances and waste (whether liquid or solid) are to be available;

(g) adequate facilities and/or arrangements for maintaining and monitoring suitable food temperature conditions are

to be available;

(h) foodstuffs are to be so placed as to avoid the risk of contamination so far as is reasonably practicable.

CHAPTER IV

TRANSPORT

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

2. Receptacles in vehicles and/or containers are not to be used for transporting anything other than foodstuffs where

this may result in contamination.

3. Where conveyances and/or containers are used for transporting anything in addition to foodstuffs or for transporting

different foodstuffs at the same time, there is, where necessary, to be effective separation of products.

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

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

6. Foodstuffs in conveyances and/or containers are to be so placed and protected as to minimise the risk of contami-

nation.

7. Where necessary, conveyances and/or containers used for transporting foodstuffs are to be capable of maintaining

foodstuffs at appropriate temperatures and allow those temperatures to be monitored.

CHAPTER V

EQUIPMENT REQUIREMENTS

1. All articles, fittings and equipment with which food comes into contact are to:

(a) be effectively cleaned and, where necessary, disinfected. Cleaning and disinfection are to take place at a frequency

sufficient to avoid any risk of contamination;

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(b) be so constructed, be of such materials and be kept in such good order, repair and condition as to minimise any

risk of contamination;

(c) with the exception of non-returnable containers and packaging, be so constructed, be of such materials and be
kept in such good order, repair and condition as to enable them to be kept clean and, where necessary, to be
disinfected; and

(d) be installed in such a manner as to allow adequate cleaning of the equipment and the surrounding area.

2. Where necessary, equipment is to be fitted with any appropriate control device to guarantee fulfilment of this

Regulation's objectives.

3. Where chemical additives have to be used to prevent corrosion of equipment and containers, they are to be used in

accordance with good practice.

CHAPTER VI

FOOD WASTE

1. Food waste, non-edible by-products and other refuse are to be removed from rooms where food is present as quickly

as possible, so as to avoid their accumulation.

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

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

4. All waste is to be eliminated in a hygienic and environmentally friendly way in accordance with Community

legislation applicable to that effect, and is not to constitute a direct or indirect source of contamination.

CHAPTER VII

WATER SUPPLY

1. (a) There is to be an adequate supply of potable water, which is to be used whenever necessary to ensure that

foodstuffs are not contaminated;

(b) Clean water may be used with whole fishery products. Clean seawater may be used with live bivalve molluscs,
echinoderms, tunicates and marine gastropods; clean water may also be used for external washing. When such
water is used, adequate facilities are to be available for its supply.

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

3. Recycled water used in processing or as an ingredient is not to present a risk of contamination. It is to be of the
same standard as potable water, unless the competent authority is satisfied that the quality of the water cannot affect
the wholesomeness of the foodstuff in its finished form.

4. Ice which comes into contact with food or which may contaminate food is to be made from potable water or, when
used to chill whole fishery products, clean water. It is to be made, handled and stored under conditions that protect it
from contamination.

5. Steam used directly in contact with food is not to contain any substance that presents a hazard to health or is likely

to contaminate the food.

6. Where heat treatment is applied to foodstuffs in hermetically sealed containers it is to be ensured that water used to

cool the containers after heat treatment is not a source of contamination for the foodstuff.

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CHAPTER VIII

PERSONAL HYGIENE

1. Every person working in a food-handling area is to maintain a high degree of personal cleanliness and is to wear

suitable, clean and, where necessary, protective clothing.

2. No person suffering from, or being a carrier of a disease likely to be transmitted through food or afflicted, for
example, with infected wounds, skin infections, sores or diarrhoea is to be permitted to handle food or enter any
food-handling area in any capacity if there is any likelihood of direct or indirect contamination. Any person so
affected and employed in a food business and who is likely to come into contact with food is to report immediately
the illness or symptoms to the food business operator.

CHAPTER IX

PROVISIONS APPLICABLE TO FOODSTUFFS

1. A food business operator is not to accept raw materials or ingredients, other than live animals, or any other material
used in processing products, if they are known to be, or might reasonably be expected to be, contaminated with
parasites, pathogenic microorganisms or toxic, decomposed or foreign substances to such an extent that, even after
the food business operator had hygienically applied normal sorting and/or preparatory or processing procedures, the
final product would be unfit for human consumption.

2. Raw materials and all ingredients stored in a food business are to be kept in appropriate conditions designed to

prevent harmful deterioration and protect them from contamination.

3. At all stages of production, processing and distribution, food is to be protected against any contamination likely to
render the food unfit for human consumption, injurious to health or contaminated in such a way that it would be
unreasonable to expect it to be consumed in that state.

4. Adequate procedures are to be in place to control pests. Adequate procedures are also to be in place to prevent
domestic animals from having access to places where food is prepared, handled or stored (or, where the competent
authority so permits in special cases, to prevent such access from resulting in contamination).

5. Raw materials,

ingredients,

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

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

7. The thawing of foodstuffs is to be undertaken in such a way as to minimise the risk of growth of pathogenic
microorganisms or the formation of toxins in the foods. During thawing, foods are to be subjected to temperatures
that would not result in a risk to health. Where run-off liquid from the thawing process may present a risk to health
it is to be adequately drained. Following thawing, food is to be handled in such a manner as to minimise the risk of
growth of pathogenic microorganisms or the formation of toxins.

8. Hazardous and/or inedible substances, including animal feed, are to be adequately labelled and stored in separate and

secure containers.

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PROVISIONS APPLICABLE TO THE WRAPPING AND PACKAGING OF FOODSTUFFS

1. Material used for wrapping and packaging are not to be a source of contamination.

CHAPTER X

2. Wrapping materials are to be stored in such a manner that they are not exposed to a risk of contamination.

3. Wrapping and packaging operations are to be carried out so as to avoid contamination of the products. Where
appropriate and in particular in the case of cans and glass jars, the integrity of the container's construction and its
cleanliness is to be assured.

4. Wrapping and packaging material re-used for foodstuffs is to be easy to clean and, where necessary, to disinfect.

CHAPTER XI

HEAT TREATMENT

The following requirements apply only to food placed on the market in hermetically sealed containers:

1. any heat treatment process used to process an unprocessed product or to process further a processed product is:

(a) to raise every party of the product treated to a given temperature for a given period of time; and

(b) to prevent the product from becoming contaminated during the process;

2. to ensure that the process employed achieves the desired objectives, food business operators are to check regularly
the main relevant parameters (particularly temperature, pressure, sealing and microbiology), including by the use of
automatic devices;

3. the process used should conform to an internationally recognised standard (for example, pasteurisation, ultra high

temperature or sterilisation).

CHAPTER XII

TRAINING

Food business operators are to ensure:

1. that food handlers are supervised and instructed and/or trained in food hygiene matters commensurate with their

work activity;

2. that those responsible for the development and maintenance of the procedure referred to in Article 5(1) of this
Regulation or for the operation of relevant guides have received adequate training in the application of the HACCP
principles; and

3. compliance with any requirements of national law concerning training programmes for persons working in certain

food sectors.

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

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

The Regulation would lay down general hygiene rules for all foodstuffs and all food business operators.
In particular, it would:

— make clear that food business operators bear the primary responsibility for food safety;

— lay down hygiene rules for all stages of the food chain, from primary production to retail;

— require food business operators to notify comptent authorities of their establishments, with a view

to their registration;

— widen existing requirements concerning hazard analysis and critical control points (HACCP);

— provide flexibility for special cases.

III. ANALYSIS OF THE COMMON POSITION

A. Generalities

The common position incorporates several changes compared to the Commission's original
proposal, many of which are consistent with the amendments that
the European Parliament
proposed in its first-reading opinion. The Commission has accepted these 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);

(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, 11, 12, 14, 15, 17 to 24, 27, 50, 54, 56, 57,

61 and 107.

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— to ensure the overall coherence of the hygiene package (1);

— to ensure the internal coherence of the Regulation (2); and

— to clarify the text (3).

It also contains a number of minor technical amendments consistent with the overall objectives of
the Regulation stated in Section II above (4).

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 primary products to the final consumer and local retail
establishments. However, the common position makes clear that:

— direct supply means supply by the primary producer;

— direct supply to local retail establishments covers only shops and restaurants (and not wholesale

or processing operations); and

— Member States must establish national rules for such direct supply that ensure the same level of

food safety as the Regulation (5).

It also contains an exemption for collection centres and tanneries that carry out no operations
related to food production other than the storage of raw material for the production of collagen or
gelatine. The Regulation laying down specific hygiene rules for food of animal origin contains
appropriate rules for such establishments.

C. HACCP (Articles 5 and 16)

The Council does not believe that it would be practicable, in the short term, to apply the principles
of hazard analysis and critical control points (HACCP) to primary production. It agrees, however, that
the Commission should review this issue and report on its conclusions within five years of entry
into force of the Regulation, as part of its report on the implementation of the Regulation. The
Council also agrees that HACCP requirements for other food business operators need to be flexible,
so as to be practicable for all types of establishments (6).

the Council agrees that

In particular,
it should be possible in certain establishments to use
procedures contained in guides rather than carrying out a full application of HACCP principles.
To ensure that this possibility does not undermine food safety objectives, however, it is appropriate
to regulate the use of guides through comitology.

(1) This consideration prevented incorporation of EP amendment 108, which deals with official controls. However,

provisions with the same aim appear in the common position on the third Regulation.

(2) These include changes consistent with the aims of EP amendments 9 and 60. However, this consideration prevented
the incorporation of amendment 10, which would have created an inconsistency between the recitals and the
Articles.

(3) These include changes consistent with the aims of EP amendments 2 to 7, 16, 25, 26, 40 to 46, 49, 51, 52, 64, 65,

67, 69 to 75, 78 and 106, and partially consistent with amendments 39 and 47.

(4) These include changes consistent with the aims of EP amendments 68, 79, 80 to 88, 90, 91, 94, 96, 99, 100 and

102.

(5) The common position is therefore consistent with the aim of EP amendment 103.
(6) The common position is therefore consistent with EP amendment 62 and with part of amendments 36 and 38, but

is not consistent with amendment 8, 35 or 37.

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D. Comitology (Articles 4 and 13)

The Council agrees that it would not be appropriate for Article 4 to impose a duty on food business
operators to comply with the provisions of Annexes that could be added to the Regulation through
comitology. It does not accept, however, that there should be no scope for granting exemptions or
for amending the existing Annexes through comitology. The common position maintains this
possibility, but contains criteria specifying the circumstances in which the Annexes could be
amended (1).

E. Guides (Articles 7 to 9)

The Council agrees that it is desirable to emphasise that all stakeholders should be involved in the
development of guides to good practice for food hygiene or for the application of the HACCP
principles. It also accepts the need for regular reviews of Community guides. However, since food
business operators would use guides on a voluntary basis,
it does not agree that it would be
appropriate to establish a hierarchy between Community and national guides (2).

F. Flexibility (Article 13)

The Council agrees that there should be 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. However, the Council does not believe that it is
appropriate to extend the procedure to Annex I, which sets general objectives rather than laying
down detailed requirements (3).

G. 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.

H. Requirements for primary producers (Annex I)

The Council agrees that
just apply to primary
the rules for primary producers should not
production but also to certain operations intimately associated with primary production. These
operations should include:

— operations carried out at the place of production that do not substantially alter the nature of

primary products;

— the transport of live animals; and

— the delivery of products of plant origin, fishery products and wild game from the place of

production to another establishment.

(1) The common position is therefore consistent with EP amendments 28 and 29, but

is not consistent with

amendments 30, 58 or 59.

(2) The common position is therefore consistent with the aim of EP amendments 40 to 46 and with part of amendment

47, but is not consistent with amendment 48.

(3) The common position is therefore consistent with EP amendment 32 and with part of amendment 31.
(4) The common position is therefore consistent with the aim of EP amendment 63.

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I. Technical requirements for operations after primary production (Annex II)

The common position incorporates a number of technical modifications to Annex II. Key among
these are:

— stricter equipment requirements;

— simpler rules on heat treatment and the transfer and generalisation of requirements that used to

be specific to heat treatment; and

— deletion of specific rules on salting and smoking, since they did not add anything to the general

requirements.

J. Other

The common position does not in general reflect the Parliament's amendments when the initial
position of the Commission was not to accept them (1). In some cases, however, the Commission
was able finally to accept modifications to its proposal that are fully (2) or partially (3) consistent
with the proposed amendments.

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.

Moreover, even when the Council and the Commission could not
the Parliament's
amendments, the common position is often closer to the Parliament's position than the Commission's
original proposal. For example, while common position would not provide for the application of HACCP
principles to primary production, it would establish basic risk-based hygiene rules for primary producers
and provides for a review of the application of HACCP principles to take place within five years.
Similarly, although the common position would maintain the possibility of making technical
amendments to the Annexes through the comitology procedure, it would place limits on the scope of
such amendments.

fully accept

(1) Amendments 13, 30, 35, 37, 48, 53, 55, 58, 59, 67, 69, 71, 76, 77, 92, 93, 95, 105 and 108.
(2) Amendments 5, 16, 28 and 29.
(3) Amendments 38, 47 and 89.