Corrigendum to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004)
Date: 2004-06-25
Institutions: Council of the European Union, European Parliament
Subjects: food hygiene, food inspection, foodstuff

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CORRIGENDA

Corrigendum to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on
the hygiene of foodstuffs

(Official Journal of the European Union L 139 of 30 April 2004)

Regulation (EC) No 852/2004 should read as follows:

REGULATION (EC) No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 29 April 2004
on the hygiene of foodstuffs

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 Commu-
nity, 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 European Economic and
Social Committee (2),

Having consulted the Committee of the Regions,

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

Whereas:

(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.

(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,
31.7.2003, p. 267), Council Common Position of 27 October 2003
(OJ C 48 E, 24.2.2004, p. 1), Position of the European Parliament of
30 March 2004 (not yet published in the Official Journal) and Council
Decision of 16 April 2004.

(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). Regulation as amended by Regulation (EC)
No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(3)

Experience has shown that these rules and procedures con-
stitute a sound basis for ensuring food safety. In the con-
text 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, contrib-
uting 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.

(5)

(6)

These principles constitute a common basis for the
hygienic production of all food, including products of ani-
mal origin listed in Annex I to the Treaty.

for

In addition to this common basis, specific hygiene rules are
necessary
certain foodstuffs. Regulation (EC)
No 853/2004 of the European Parliament and of the Coun-
cil of 29 April 2004 laying down specific hygiene rules for
food of animal origin (6) lays down these rules.

(5) OJ L 175, 19.7.1993, p. 1. Directive as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council (OJ
L 284, 31.10.2003, p. 1).

(6) See page 22 of this Official Journal.

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(7)

(8)

(9)

(10)

The principal objective of the new general and specific
hygiene rules is to ensure a high level of consumer protec-
tion with regard to food safety.

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.

Community rules should not apply either to primary pro-
duction for private domestic use, or to the domestic prepa-
ration, handling or storage of food for private domestic
consumption. Moreover, they should apply only to under-
takings, the concept of which implies a certain continuity
of activities and a certain degree of organisation.

Food hazards present at the level of primary production
should be identified and adequately controlled to ensure
the achievement of the objectives of this Regulation. How-
ever, in the case of the direct supply of small quantities of
primary products, by the food business operator produc-
ing them, to the final consumer or to a local retail estab-
lishment, it is appropriate to protect 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 the use of appropriate hygiene practices at farm
level. Where necessary, specific hygiene rules for primary
production should supplement these guides. It is appropri-
ate for the hygiene requirements applicable to primary
production and associated operations to differ from those
for other operations.

(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 ele-
ment of the review that the Commission will carry out fol-
lowing implementation of this Regulation. It is, however,
appropriate for Member States to encourage operators at
the level of primary production to apply such principles as
far as possible.

(15) The HACCP requirements should take account of the prin-
ciples contained in the Codex Alimentarius. They should
provide sufficient flexibility to be applicable in all situa-
tions, including in small businesses. In particular, it is nec-
essary 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 monitoring
of critical control points. Similarly, the requirement of
establishing ‘critical limits’ does not imply that it is neces-
sary 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.

(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 struc-
tural requirements for establishments. Flexibility is particu-
larly important for regions that are subject to special geo-
graphical constraints,
including the outermost regions
referred to in Article 299(2) of the Treaty. However, flex-
ibility should not compromise food hygiene objectives.
Moreover, since all food produced in accordance with the
hygiene rules will be in free circulation throughout the
Community, the procedure 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 established by Regulation (EC)
No 178/2002.

(12)

(13)

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’ com-
pliance and food business operators should establish and
operate food safety programmes and procedures based on
the HACCP principles.

Successful implementation of the procedures based on the
HACCP principles will require the full cooperation and
commitment of food business employees. To this end,
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.

(17) The setting of objectives such as pathogen reduction tar-
gets or performance standards may guide the implemen-
tation of hygiene rules. It is therefore necessary to provide
procedures for that purpose. Such objectives would supple-
ment 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
for the 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.

(1) OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation

(EC) No 1882/2003.

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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 con-
ferred 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 compe-
tent authorities to perform official controls efficiently.

(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.

(21)

requirements

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

(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.

(23)

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

(24)

Since this Regulation replaces Directive 93/43/EEC, the lat-
ter should be repealed.

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1.
This Regulation lays down general rules for food business
operators on the hygiene of foodstuffs, taking particular account
of the following principles:

(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 ambi-
ent temperatures, particularly frozen food, to maintain the
cold chain;

(d) general implementation of procedures based on the HACCP
principles, together with the application of good hygiene
practice,
food business operators’
responsibility;

reinforce

should

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

(f)

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

(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.

(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 the new rules, to allow the affected indus-
tries time to adapt.

This Regulation shall apply to all stages of production, process-
ing and distribution of food and to exports, and without preju-
dice to more specific requirements relating to food hygiene.

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

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2.

This Regulation shall not apply to:

(a) primary production for private domestic use;

capable of directly or indirectly affecting the health quality of
food;

(b)

the domestic preparation, handling or storage of food for pri-
vate domestic consumption;

(c)

the direct supply, by the producer, of small quantities of pri-
mary products to the final consumer or to local retail estab-
lishments directly supplying the final consumer;

(i)

(j)

‘clean water’ means clean seawater and fresh water of a simi-
lar quality;

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

(d) collection centres and tanneries which fall within the defini-
tion of food business only because they handle raw material
for the production of gelatine or collagen.

(k)

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

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

(l)

‘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:

(m) ‘processing’ means any action that substantially alters the ini-
tial product, including heating, smoking, curing, maturing,
drying, marinating, extraction, extrusion or a combination of
those processes;

(a)

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

(n)

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

(b)

‘primary products’ means products of primary production
including products of the soil, of stock farming, of hunting
and fishing;

(c)

‘establishment’ means any unit of a food business;

(d)

(e)

(f)

(g)

‘competent authority’ means the central authority of a Mem-
ber State competent to ensure compliance with the require-
ments of this Regulation or any other authority to which that
central authority has delegated that competence; it shall also
include, where appropriate, the corresponding authority of a
third country;

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

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

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

(h)

‘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

(1) OJ L 330, 5.12.1998, p. 32. Directive as amended by Regulation

(EC) No 1882/2003.

(o)

‘processed products’ means foodstuffs resulting from the pro-
cessing of unprocessed products. These products may con-
tain ingredients that are necessary for their manufacture or to
give them specific characteristics.

The definitions laid down in Regulation (EC) No 178/2002

2.
shall also apply.

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

CHAPTER II

FOOD BUSINESS OPERATORS’ OBLIGATIONS

Article 3

General obligation

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

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Article 4

Article 5

General and specific hygiene requirements

Hazard analysis and critical control points

Food business operators carrying out primary production
1.
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 Regulation
(EC) No 853/2004.

2.
Food business operators carrying out any stage of produc-
tion, 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 requirements
provided for in Regulation (EC) No 853/2004.

Food business operators shall, as appropriate, adopt the fol-

3.
lowing specific hygiene measures:

(a)

compliance with microbiological criteria for foodstuffs;

Food business operators shall put in place, implement and
1.
maintain a permanent procedure or procedures based on the
HACCP principles.

The HACCP principles referred to in paragraph 1 consist of

2.
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 acceptability from unacceptability for the preven-
tion, elimination or reduction of identified hazards;

(b) procedures necessary to meet targets set to achieve the objec-

tives of this Regulation;

(d) establishing and implementing effective monitoring proce-

dures at critical control points;

(c)

compliance with temperature control requirements for
foodstuffs;

(e)

establishing corrective actions when monitoring indicates
that a critical control point is not under control;

(d) maintenance of the cold chain;

(f)

establishing procedures, which shall be carried out regularly,
to verify that the measures outlined in subparagraphs (a)
to (e) are working effectively;

(e)

sampling and analysis.

and

4.
The criteria, requirements and targets referred to in para-
graph 3 shall be adopted in accordance with the procedure
referred to in Article 14(2).

(g) establishing documents and records commensurate with the
nature and size of the food business to demonstrate the effec-
tive application of the measures outlined in subparagraphs (a)
to (f).

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

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.

5. When this Regulation, Regulation (EC) No 853/2004 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 equivalent results to
those obtained using the reference method, if they are scientifi-
cally validated in accordance with internationally recognised rules
or protocols.

3.
Paragraph 1 shall apply only to food business operators car-
rying out any stage of production, processing and distribution of
food after primary production and those associated operations
listed in Annex I.

4.

Food business operators shall:

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

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

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

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

(c)

retain any other documents and records for an appropriate
period.

CHAPTER III

GUIDES TO GOOD PRACTICE

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 com-
ply with paragraph 1. Such arrangements may also specify the
period during which food business operators shall retain docu-
ments and records in accordance with paragraph 4(c).

Article 6

Official controls, registration and approval

Food business operators shall cooperate with the competent
1.
authorities in accordance with other applicable Community leg-
islation or, if it does not exist, with national law.

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 establishment.

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;

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 principles in accordance with Article 8. Community
guides shall be developed in accordance with Article 9.

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

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 inter-
ests may be substantially affected, such as competent authori-
ties 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 recommen-
dations set out in Part B of Annex I.

National guides may be developed under the aegis of a
2.
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) under Regulation (EC) No 853/2004;

(b)

their contents are practicable for the sectors to which they
refer;

or

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

referred to in Article 14(2).

and

(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 informa-
tion in the field of technical standards and regulations (OJ L 204,
21.7.1998, p. 37). Directive as last amended by the 2003 Act of
Accession.

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(c)

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

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.

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

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

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

Article 9

Community guides

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:

CHAPTER IV

IMPORTS AND EXPORTS

Article 10

Imports

As regards the hygiene of imported food, the relevant require-
ments of food law referred to in Article 11 of Regulation (EC)
No 178/2002 shall
include the requirements laid down in
Articles 3 to 6 of this Regulation.

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

Article 11

Exports

(b)

in collaboration with parties whose interests may be substan-
tially affected, including competent authorities;

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

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

Alimentarius;

and

(d) when they concern primary production and those associated
operations listed in Annex I, having regard to the recommen-
dations set out in Part B of Annex I.

CHAPTER V

FINAL PROVISIONS

Article 12

Implementing measures and transitional arrangements

The Committee referred to in Article 14 shall assess draft

3.
Community guides in order to ensure that:

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

(a)

they have been developed in accordance with paragraph 2;

(b)

their contents are practicable for the sectors to which they
refer throughout the Community;

and

Article 13

Amendment and adaptation of Annexes I and II

Annexes I and II may be adapted or updated in accordance
1.
with the procedure referred to in Article 14(2), taking into
account:

(c)

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

(a)

the need to revise the recommendations set out in Annex I,
Part B, paragraph 2;

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(b)

the experience gained from the implementation of HACCP-
based systems pursuant to Article 5;

(d) give any other relevant information.

(c)

technological developments and their practical consequences
and consumer expectations with regard to food composition;

(d)

scientific advice, particularly new risk assessments;

(e) microbiological and temperature criteria for foodstuffs.

2.
Derogations from Annexes I and II may be granted, in par-
ticular in order to facilitate the implementation of Article 5 for
small businesses, in accordance with the procedure referred to in
Article 14(2), taking into account the relevant risk factors, pro-
vided that such derogations do not affect the achievement of the
objectives of this Regulation.

3. Member States may, without compromising achievement of
the objectives of this Regulation, adopt, in accordance with para-
graphs 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 food businesses situ-
ated in regions that are subject to special geo-
graphical constraints.

(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:

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

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 adaptations aris-
ing 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 commit-
tee 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 may be implemented, subject, if
necessary,
to appropriate amendments. Where appropriate,
the Commission may propose general measures in accordance
with paragraph 1 or 2.

A Member State may adopt national measures adapting the

7.
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
to propose the adoption of a decision in accordance with
paragraph 6.

Article 14

Committee procedure

The Commission shall be assisted by the Standing Commit-

1.
tee 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 pro-
visions of Article 8 thereof.

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

3.

The Committee shall adopt its Rules of Procedure.

(b) describe the foodstuffs and establishments concerned;

Article 15

(c)

explain the reasons for the adaptation, including, where rel-
evant, by providing a summary of the hazard analysis carried
out and any measures to be taken to ensure that the adapta-
tion will not compromise the objectives of this Regulation;

and

Consultation of the European Food Safety Authority

The Commission shall consult the European Food Safety Author-
ity on any matter falling within the scope of this Regulation that
could have a significant impact on public health and, in particu-
lar, before proposing criteria, requirements or targets in accor-
dance with Article 4(4).

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Article 16

Report to the European Parliament and the Council

The Commission shall, not later than 20 May 2009, submit

1.
a report to the European Parliament and the Council.

2.
The report shall, 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.

Pending the application of new Community legislation lay-
4.
ing down rules for official controls on food, Member States shall
take all appropriate measures to ensure the fulfilment of the obli-
gations laid down in or under this Regulation.

Article 18

Entry into force

This Regulation shall enter into force on the 20th day after that
of its publication in the Official Journal of the European Union.

The Commission shall, if appropriate, accompany the report

3.
with relevant proposals.

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

Article 17

Repeal

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

1.
date of application of this Regulation.

(a) Regulation (EC) No 853/2004;

(b) Regulation (EC) No 854/2004 of the European Parliament
and of the Council of 29 April 2004 laying down specific
rules for the organisation of official controls on products of
animal origin intended for human consumption (1);

References to the repealed Directive shall be construed as

2.
being made to this Regulation.

and

However, decisions adopted pursuant

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

(c) Directive 2004/41/EC of the European Parliament and of the
Council of 21 April 2004 repealing certain directives con-
cerning food hygiene and health conditions for the produc-
tion 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 Strasbourg, 29 April 2004.

For the European Parliament
The President
P. COX

For the Council
The President
P. M. McDOWELL

(1) See page 83 of this Official Journal.
(2) OJ L 157, 30.4.2004, p. 33.

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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;

(c)

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 pri-
mary products, the nature of which has not been substantially altered, from the place of production to an
establishment.

II. Hygiene provisions

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

tion, 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 prod-

ucts, 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 facili-
ties used to store and handle feed, clean and, where necessary after cleaning, to disinfect them in an appro-
priate manner;

(b)

to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, equipment, con-
tainers, 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;

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(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, includ-
ing 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.

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, equip-
ment, 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 offi-
cial 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;

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(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.

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 pro-
duction and associated operations and actions to control hazards, including relevant measures set out in Community
and national legislation or national and Community programmes. Examples of such hazards and measures may include:

(a)

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

(b)

the use of water, organic waste and fertilisers;

(c)

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)

CHAPTER I

1.

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

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 pro-
vide 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 moni-
tored 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 contami-
nated 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.

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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.

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.

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

CHAPTER II

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 prac-
tices, 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 eas-
ily 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.

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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.

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

CHAPTER III

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.

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 disin-
fect. This will require the use of smooth, washable, corrosion-resistant and non-toxic materials, unless food busi-
ness 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 sub-
stances 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 per-
mit 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.

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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 contamination.

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

stuffs 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;

(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 Regu-

lation’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.

2.

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.

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.

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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 food-

stuffs are not contaminated;

(b) Clean water may be used with whole fishery products. Clean seawater may be used with live bivalve molluscs, echi-
noderms, 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 pur-
poses, 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.

4.

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.

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.

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 suit-
able, 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,
and if possible their causes, 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 para-
sites, 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 prod-
uct 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.

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3. At all stages of production, processing and distribution, food is to be protected against any contamination likely to ren-
der the food unfit for human consumption, injurious to health or contaminated in such a way that it would be unrea-
sonable 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 domes-
tic 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 patho-
genic 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 accom-
modate 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 processed foodstuffs are
to have suitable rooms, large enough for the separate storage of raw materials from 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 micro-
organisms 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.

CHAPTER X

Provisions applicable to the wrapping and packaging of foodstuffs

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

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 appro-
priate 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;

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2.

3.

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 auto-
matic devices;

the process used should conform to an internationally recognised standard (for example, pasteurisation, ultra high tem-
perature or sterilisation).

CHAPTER XII

Training

Food business operators are to ensure:

1.

2.

that food handlers are supervised and instructed and/or trained in food hygiene matters commensurate with their work
activity;

that those responsible for the development and maintenance of the procedure referred to in Article 5(1) of this Regu-
lation 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.