Proposal for a Regulation of the European Parliament and of the Council on the hygiene of foodstuffs
Date: 2000-07-14
Institutions: European Commission
Subjects: animal product, consumer protection, food inspection, foodstuff, health legislation

19.12.2000

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Official Journal of the European Communities

C 365 E/43

Proposal for a Regulation of the European Parliament and of the Council on the hygiene of
foodstuffs

(2000/C 365 E/02)

(Text with EEA relevance)

COM(2000) 438 final (cid:16) 2000/0178(COD)

(Submitted by the Commission on 14 July 2000)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

being harmed
consumption,

by

foodstuffs

unfit

for human

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,

Having regard to the opinion of
Committee,

the Economic and Social

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

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

Whereas:

(1) The protection of human health is of paramount

importance.

(2) In the context of the internal market, Council Directive
93/43/EEC of 14 June 1993 on the hygiene of
foodstuffs (1) has been adopted in order to ensure the
safety of foodstuffs for human consumption in free circu-
lation.

(3) This Directive fixes the principles with regard to food

hygiene and in particular:

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

9 the need to base the standard of hygiene on the use of
other
and

assessment
to identify,

risk
techniques

and
control

hazard
management
monitor critical points,

analysis,

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

9 the development of guides to good hygiene practice to

which food businesses may refer,

9 the need for the competent authorities of the Member
States to ensure the observance of the hygiene rules
with the aim of preventing the final consumer from

(1) OJ L 175, 19.7.1993, p. 1.

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

(4) Experience has shown that these principles constitute a

sound basis for ensuring food safety.

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

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

(7) These specific rules are contained in a large number of

Directives.

(8) With regard to public health,

these Directives contain
common principles such as those related to the responsi-
bilities of manufacturers of products of animal origin, the
the technical
the competent authorities,
obligations of
requirements for the structure and operation of estab-
lishments handling products of
the
hygiene requirements which must be complied with in
these establishments, the procedures for the approval of
establishments, the conditions for storage and transport,
the health marking of the products, etc.

animal origin,

(9) Many of these principles are the same as the principles

laid down in Council Directive 93/43/EEC.

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

food,

(11) In addition to this common basis, specific hygiene rules
are needed in order to take the specificity of certain
foodstuffs into account. The specific hygiene rules for
products of animal origin are contained in European
Parliament and Council Regulation . . .
laying down
specific hygiene rules for food of animal origin.

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

the
laid down by the Codex Alimentarius allowing at
same time the flexibility needed for its application in all
situations, and in particular in small businesses.

9 the principle that primary responsibility for

food

safety rests with the manufacturer,

9 the need to ensure food safety throughout the food

chain, starting with primary production,

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

constraints;

9 maintaining the cold chain for food that cannot safely

be stored at ambient temperatures,

(19) For

food which cannot be safely stored at ambient
the

the maintenance of
temperatures,
cold chain is a basic principle of food hygiene.

the integrity of

9 general implementation of the hazard analysis critical
together with the
system which,
control points
application
should
of
reinforce the responsibility of food business operators,

practice,

hygiene

good

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

9 that codes to good practice are a valuable instrument
for guiding food business operators at all levels of the
food chain on the compliance with food hygiene rules,

(21) The traceability of food and food ingredients along the
food chain is an essential element in ensuring food safety.

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

9 the establishment of microbiological

criteria and
temperature control requirements based on a scientific
assessment of risk,

9 the need to ensure that imported foods are of at least

the same or an equivalent health standard.

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

(14) Food hazards already present at

the level of primary
production must be identified and adequately controlled.

(15) Hygiene at farm level can be organised through the use of
codes of good practice, supplemented where necessary
with specific hygiene rules to be observed during the
production of primary products.

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

(22) Food businesses should be registered with the competent
to be

to allow official controls

authority in order
performed efficiently.

(23) Food operators shall give all assistance required in order
to ensure that official controls can be carried out
efficiently by the competent authorities.

(24) Food imported into the Community shall be of the same
hygiene level as the food obtained in the Community, or
be of level equivalent thereto.

(25) In order to ensure a high level of protection and to
prevent deflections of
food obtained in the
trade,
Community and exported towards third countries shall
not be of a lesser hygiene standard than the food
produced and consumed within the Community.

(26) Scientific advice must underpin Community legislation on
food hygiene; to this end, the scientific committees in the
field of consumer protection and food safety set up by
Commission Decision 97/579/EC of 23 July 1997 (1) and
the Scientific Steering Committee set up by Commission
Decision 97/404/EC of 10 June 1997 (2)
should be
consulted wherever necessary.

(27) In order

to take account of

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

(17) The hazard analysis critical control point system in food
production should take account of the principles already

(1) OJ L 237, 28.8.1997, p. 18.
(2) OJ L 169, 27.6.1997, p. 85.

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(28) The present Regulation takes into account

the inter-
national obligations laid down on the WTO-Sanitary
and Phytosanitary Agreement and in Codex Alimentarius.

all of the stages from and including primary production up
to and including the offering for sale or supply of foodstuffs
to the final consumer,

(29) The present recast of existing Community hygiene rules
means that the existing hygiene rules can be repealed; this
is achieved through Council Directive . . /. . ./EC repealing
certain Directives on the hygiene of foodstuffs and on the
health conditions for the production and placing on the
market of certain products of animal origin intended for
human
Directives
and
89/662/EEC and 91/67/EEC.

consumption,

amending

(30) Since the measures necessary for the implementation of
this Regulation are measures of general scope within the
meaning of Article 2 of council Decision 1999/468/EEC
of 28 June 1999 laying down the procedures for the
conferred on the
exercise of
Commission (1), they should be adopted by use of the
regulatory procedure provided for in Article 5 of that
Decision,

implementing powers

HAVE ADOPTED THIS REGULATION:

Article 1

Scope

9 Bfood business operatorC means the person or persons
responsible for ensuring that the requirements of this Regu-
lation are met within the food business under his/their
control,

9 Bprimary productsC means products of the soil, of stock

farming, of hunting and fisheries,

9 Bprimary productionC means the production, rearing or
growing of primary products up to and including
harvesting, hunting,
stages of
animal production prior to slaughter,

fishing, milking and all

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

9 BcertificationC means the procedure by which the competent
authorities provide written or equivalent assurance of
conformity to requirements,

This Regulation lays down the rules to ensure the hygiene of
foodstuffs at all stages from and including primary production
up to and including the offering for sale or supply of a
foodstuff to the final consumer. This Regulation shall apply
without prejudice to more specific requirements relating to
food safety, and does not cover issues relating to nutrition or
compositional matters.

It applies to food businesses and does not apply to the primary
production of food for private domestic use or the domestic
preparation of foodstuffs for private consumption.

9 BequivalenceC means the capability of different systems to

meet the same objectives,

9 BhazardC means a biological, chemical or physical agent with

the potential to compromise food safety,

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

Article 2

Definitions

For the purposes of this Regulation:

9 Bfood hygieneC, hereinafter called BhygieneC, means

the
measures and conditions necessary to control hazards and
ensure fitness for human consumption of a foodstuff taking
into account its intended use,

9 BmarketingC means holding, displaying and offering for sale,
selling, delivering or any other form of placing on the
market in the Community,

9 Bretail tradeC means the handling and processing of food and
its storage at the point of sale or delivery to the final
consumer, and includes mass catering operations, factory
and other
canteens,
catering,
similar
supermarket
distribution centres, wholesale outlets selling wrapped and
packaged foodstuffs,

restaurants
shops,

service operations,

institutional

food

9 Bfood safetyC means the assurance that food will not cause
adverse health effects to the final consumer when it is
prepared and eaten taking into account its intended use,

9 Bfinal consumerC means the ultimate consumer of a foodstuff
who shall not use the food as part of any food business
operation or activity,

9 Bfood businessC means any undertaking, whether for profit
or not and whether public or private, carrying out any or

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

9 BwrappingC means the protection of a product by the use of
an initial wrapping or initial container in direct contact
with the product concerned, and the initial wrapper or
initial container itself,

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

9 Bproducts of animal originC means foodstuffs obtained from

animals, including honey,

9 Bproduct of plant originC means foodstuffs obtained from

plants,

9 Bunprocessed productC means foodstuffs which have not
including products which have
severed, boned,
trimmed, husked

undergone a treatment,
been,
example, divided, parted,
minced, skinned, ground, cut, cleaned,
or milled, chilled, frozen or deep-frozen,

for

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

9 Bhermetically sealed containerC means a container that is
designed and intended to be secure against the entry of
micro-organisms,

9 Bwhere necessaryC,

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

Food business operators, other

than referred to in
2.
paragraph 1, shall comply with the general hygiene provisions
in Annex II, any other specific provisions laid down in Regu-
lation . . .
(laying down specific hygiene rules for food of
animal origin) and in any other annexes which may be
added in accordance with the procedure laid down in Article
15.

Exemptions from provisions of the Annexes referred to in
3.
paragraphs 1 and 2 may be granted by the Commission in
accordance with the procedure laid down in Article 15,
provided that such exemptions do not affect the achievement
of the objectives of this Regulation.

4. Member States may adapt the requirements laid down in
Annex II with a view to accommodate the needs of food busi-
nesses situated in regions suffering from special geographical
constraints or affected by supply difficulties which are serving
the local market, or with a view to take account of traditional
methods of production. The objectives of food hygiene shall
not be compromised.

Member States having recourse to this possibility shall inform
the Commission and the other Member States thereof. Member
States shall have one month from the receipt of the notification
to send written comments to the Commission. Where written
comments are made, the Commission shall take a decision in
accordance with the procedure referred to in Article 15(2).

Article 5

Hazard analysis and critical control points system

Food business operators other

the level of
1.
primary production shall put
and
maintain a permanent procedure developed in accordance
with the following principles of the system of hazard analysis
and critical control points (HACCP):

implement

in place,

than at

Article 3

General obligation

Food business operators shall ensure that all stages for which
they are responsible from and including primary production up
to and including the offering for sale or supply of foodstuffs to
the final consumer are carried out
in a hygienic way in
accordance with this Regulation.

(a) identify any hazards that must be prevented, eliminated or

reduced to acceptable levels,

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

Article 4

General hygiene

requirements

and specific hygiene

requirements

at

the

Food business operators

level of primary
1.
production shall comply with the general hygiene provisions
in Annex I hereto, any other specific provisions in Regulation
. . .
(laying down specific hygiene rules for food of animal
origin), and in any other Annexes which may be added in
accordance with the procedure laid down in Article 15.

(c) establish critical

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

from unacceptability

acceptability

for

(d) establish and implement effective monitoring procedures at

critical control points,

(e) establish corrective actions when monitoring indicates that

a critical control point is not under control.

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Food business operators shall establish procedures to
2.
verify whether
the measures outlined in paragraph 1 are
working effectively. Verification procedures shall be carried
out
the food business operation
changes in a manner that could adversely affect food safety.

regularly and whenever

to demonstrate the effective application of

Food business operators shall establish documents and
3.
the food
records commensurate to the nature and size of
business
the
measures outlined in paragraphs 1 and 2, and to facilitate
official controls. Such documents shall be kept by the food
business operator for at least the time of the shelf life of the
product.

4.
As part of the system referred to in paragraphs 1, 2 and
3, food business operators may use guides to good practice in
conjunction with guides on the application of HACCP, as
developed in accordance with Articles 7 and 8. Such guides
must be appropriate for the operations and foods to which
they are applied by the food business operator.

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

institute

referred to in Annex I

National guides may be developed under the aegis of a national
standards
to Directive
98/34/EC (1) of the European Parliament and of the Council
of 22 June 1998 laying down a procedure for the provision of
information in the field of technical standards and regulations
as amended by Directive 98/48/EC (2).

3. Member States shall assess national guides to ensure:

9 that the contents of such guides are practicable for the

sectors to which they refer,

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

5.
In accordance with the procedure referred to in Article
15, the Commission may adopt measures in order to facilitate
the implementation of this Article, in particular in small busi-
nesses.

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

Article 6

Specific food safety requirements

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

In accordance with the procedure referred to in Article 15 and
after
competent Scientific Committee or
Committees:

consulting the

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

1. Microbiological

temperature
criteria
foodstuffs may be adopted and/or amended.

and

criteria

for

2. Targets and/or performance standards in order to facilitate

the implementation of this Regulation may be set.

Article 7

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

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

to good practice referred to in
2. Where the guides
paragraph 1 are developed, they shall be developed as follows:

9 by food business
interested parties,
consumer groups,

sectors and representatives of other
such as appropriate authorities and

Twelve months following the coming into force of this
4.
Regulation, and thereafter annually, the Member States shall
forward to the Commission a report concerning the steps
taken to develop national guides specified in paragraph 1.

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

Article 8

Community guides

1. Where a Member State or the Commission considers that
there is a need for uniform Community guides to good
practice, and/or Community guides on the application of the
principles of HACCP (hereinafter referred to as Community
guides), the Commission shall consult the relevant Committee
referred to in Article 15. The objective of this consultation shall
be to consider the case for such guides, their scope and subject
matter.

9 in consultation with interests
including competent authorities,

substantially

affected,

(1) OJ L 204, 21.7.1998, p. 37.
(2) OJ L 217, 5.8.1998, p. 18.

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2. Where Community guides are prepared, steps shall be
taken to ensure that they are developed with representatives
of the sector concerned and other interested parties, such as
appropriate competent authorities and consumer groups,
taking into account the Recommended International Code of
Practice, General Principles of Food Hygiene, of
the Codex
Alimentarius and any national guides developed in accordance
with Article 7.

3.
The relevant Committee or Committees referred to in
Article 15 shall be responsible for assessing Community
guides. Measures
shall be taken by such Committee or
Committees to ensure that:

9 the contents of such guides are practicable for the sectors

to which they refer throughout the Community,

9 all interests substantially affected by such guides have been
consulted, and the relevant comments taken into account,

9 where

they exist, national guides

forwarded to the
Commission under Article 7(5) have been taken into
account,

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

4. Where national guides have been produced in accordance
with Article 7 and subsequently Community guides are
produced in accordance with this Article,
food business
operators may refer to either.

5.
The titles and references of Community guides prepared
in accordance with the procedure in paragraphs 1 to 3 shall be
published in the C series of the Official Journal of the European
Communities. Member States shall ensure that such published
guides are drawn to the attention of the relevant food business
sectors and the appropriate authorities in their territories.

Article 9

Registration or approval of food businesses

Food business operators

1.
shall ensure that all estab-
lishments under their control and covered by this Regulation
are registered with the competent authority/ies outlining the
nature of the business, the name and address of all premises
where food business activities are carried out. The competent
authority/ies shall allocate a registration number to each food
establishment and keep an up to date list thereof.

Food business operators except those operating at retail
foodstuffs produced by them are
shall ensure that

2.
level
identified with their registration number.

Community rules, food businesses must be approved and shall
not operate without such approval. The competent authority
shall only approve those establishments where, after a visit by
officials of the competent authority/ies it has been ascertained
that all the requirements of this regulation are met.

Article 10

Withdrawal of products/traceability

Food business operators

1.
shall ensure that adequate
procedures are in place to withdraw food from the market
where such food presents a serious risk to the health of
consumers. Where a food business operator identifies that a
foodstuff presents a serious risk to health it shall immediately
withdraw that foodstuff from the market. When a serious risk
has been identified and when a foodstuff has been withdrawn
from the market due to risk to the health of the consumer,
food
inform the
shall
competent authority thereof.

business operators

immediately

Food business operators shall keep adequate records
2.
which enable them to identify the supplier of ingredients and
foods used in their operation and where appropriate the prov-
enance of the animals used for food production.

3. Where necessary to ensure appropriate traceability of
food or food ingredients,
lay down
detailed rules in accordance with the procedure provided for
in Article 15.

the Commission shall

Article 11

Official controls

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

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

infrastructures,

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

Article 12

Imports/exports

1.
Foodstuffs imported into the Community shall comply
with the provisions of Articles 3, 4 and 5 and any provision
laid down pursuant to Article 6, or with provisions that are
equivalent to those laid down in this Regulation.

3. Where the competent authority/ies considers it necessary
for the purposes of assuring that
this
Regulation are met, or where required by more specific

the requirements of

2.
Foodstuffs for exportation out of the Community shall
comply with the provisions of Articles 3, 4, 5, 9 and any
provisions
laid down under Article 6, except where the
importing country specifies otherwise.

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Article 13

Amending of annexes and implementing measures

Provisions in the Annexes to this Regulation may be
in

1.
repealed,
accordance with the procedure laid down in Article 15.

supplemented

amended

adapted,

and/or

1999/468/EC shall apply, in compliance with Article 7(3) and
Article 8 thereof.

The period provided for in Article 5(6) of Decision

3.
1999/468/EC shall be 3 months.

2.
Implementing measures in relation to Articles 4, 5, 9, 10
and 12 may be adopted in accordance with the procedure laid
down in Article 15.

Article 16

Report to Council and Parliament

Article 14

References to international standards

Amendments to references to international standards contained
in this Regulation, such as those of the Codex Alimentarius,
may be adopted in accordance with the procedure referred to
in Article 15.

Article 15

Standing committee procedure

Committee

The Commission shall be assisted by the Standing
1.
Veterinary
Council Decision
instituted
68/361/EEC (1) and by the Standing Committee for foodstuffs,
instituted by European Parliament and Council Decision
69/414/EEC (2).

by

1.
The Commission shall submit a report to the European
Parliament and the Council, where appropriate with any
relevant proposals, within seven years of
this Regulation
entering into force, reviewing the experience gained from
implementing this Regulation.

2.
In order to allow the Commission to establish the report
referred to in paragraph 1, Member States shall submit all
necessary information to the Commission 12 months before
the period referred to in paragraph 1.

Article 17

Entry into force

This Regulation shall enter into force on the date of its publi-
cation in the Official Journal of the European Communities.

It shall apply from 1 January 2004.

2. Where reference is made to this paragraph, the Regu-
laid down in Article 5 of Decision
latory procedure

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

(1) OJ L 255, 18.10.1968, p. 23.
(2) OJ L 291, 19.11.1969, p. 9.

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ANNEX I

GENERAL HYGIENE RULES FOR PRIMARY PRODUCTION

Preface

This Annex applies to the production of primary products and includes any activity carried out to that effect at that
level (farms, hunting, etc).

CHAPTER I

Requirements for all food

1. Possible hazards occurring in primary production and methods to control such hazards shall, where possible, be
addressed in the guides to good practice referred to in Articles 7 and 8. These guides may be combined with other
guides or codes of practice required in particular under other relevant Community legislation.

2. Primary production shall be carried out in accordance with good practice and managed in such a way that hazards
are monitored and where necessary eliminated or reduced to an acceptable level, taking into account normal
processing procedures carried out after primary production. This includes, where appropriate,

9 adopting practices and measures to ensure that food and food sources are produced under appropriate hygienic

conditions,

9 adopting measures with regard to hazards from the environment,

9 controlling contaminants, pests, diseases and infections of animals and plants,

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

CHAPTER II

Requirements for products of animal origin

1.

In the codes of good practice, actions to be taken in order to ensure the hygiene of food shall be described. This
includes, where appropriate:

9 implementing suitable cleaning and disinfection procedures for animal housing, equipment, premises, transport

crates and vehicles, etc.,

9 taking precautions when introducing new animals onto a farm, fish farm, molluscs growing area, etc.,

9 proper use of veterinary medicinal products and feed additives,

9 proper disposal of dead animals, waste and litter,

9 implementing effective pest-control programmes,

9 isolating diseased animals,

9 the cleanliness of slaughter animals,

9 protective measures to prevent the introduction of contagious diseases or diseases transmissible to humans,

9 the possible hazards associated with feedingstuffs,

9 a description of the problems that may affect human health and that need to be reported to the competent

authority,

9 the implementation of hygiene control programmes, zoonoses control programmes and herd health surveillance

programmes.

2. Farmers shall keep records or documentation containing information relevant to health protection. They shall in

particular include information on:

9 the nature and origin of feedingstuffs,

9 the animal health status and the welfare of the animals at the farm,

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9 the use of veterinary medicinal products (nature of the treatment and date of application),

9 the occurrence of diseases which may affect the safety of products of animal origin (e.g. udder infections),

9 the results of any analyses carried out on samples taken from animals or other samples that have importance to

human health, in particular with regard to control programmes for certain zoonotic agents,

9 any reports from the slaughterhouse about ante- and post-mortem findings.

Farmers shall be assisted by the those responsible for the animals at the farm (veterinarians, agronomists, farm
technicians. etc.) for completing the above records or documentation.

Records or documentation may be combined with records that may be required under other Community or national
acts. Farmers must keep the records or documentation referred to above for submission to the competent authority
on demand during a period to be set by the latter.

Information relevant to food safety which is contained in these records or documentation must accompany slaughter
animals to the slaughterhouse or where appropriate animal products to processing factories in order to inform the
competent authority and the receiving food operator about the health status of the herd.

CHAPTER III

Requirements for products of plant origin

1.

In the codes of good practice, actions to be taken in order to ensure the hygiene of food shall be described. This
includes, where appropriate:

9 the correct and appropriate use of plant-protection products and fertilisers,

9 appropriate production, handling, storage and transport methods,

9 practices and measures to avoid contamination with biological, chemical or physical hazards such as mycotoxins,

heavy metals, radioactive material, etc.

9 the use of water in primary production,

9 the use of organic waste in primary production,

9 the cleaning and where necessary disinfection of machinery, equipment and vehicles used for transport.

2. Farmers, where necessary assisted by those responsible for the hygiene at the farm (agronomists, farm technicians,
etc.), shall keep records or documentation containing information relevant to health protection, and in particular on:

9 the correct and appropriate use of plant-protection products and fertilisers,

9 the results of analyses carried out on samples taken on products or of other analysis made.

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

ANNEX II

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

Introductory remarks

The remaining Chapters of the Annex apply as follows:

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

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

excluding dining areas,

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

9 Chapter IV to all transportation.

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

CHAPTER I

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

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

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

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

(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 cross-contamination between and during
separate operations from foodstuffs, wrapping and packaging materials, equipment, materials, water, air supply
or personnel and external sources of contamination such as pests;

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

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

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

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

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

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

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

9. Where required for the purposes of hygiene, adequate changing facilities for personnel must be provided as

necessary.

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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) the design and layout shall permit
good food hygiene practices, including protection against cross-contamination between and during operations, and in
particular:

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

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

(c) ceilings and overhead fixtures must be constructed to prevent the accumulation of dirt and reduce condensation,

the growth of undesirable moulds and the shedding of particles;

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

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

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

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

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

CHAPTER III

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

1. Premises and vending machines shall be so sited, designed, constructed and kept clean and maintained in good repair
and condition as to avoid the risk of contaminating foodstuffs and harbouring pests, so far as is reasonably prac-
ticable.

2. In particular and where necessary:

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

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

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

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(c) adequate provision must be made for the cleaning and,

if necessary, disinfecting of working utensils and

equipment;

(d) where foodstuffs are cleaned as part of the food business’s operations adequate provision must be made for this

to be undertaken hygienically;

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

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

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

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

must be available;

(h) foodstuffs must 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 must be kept clean and maintained in good repair
and condition in order to protect foodstuffs from contamination and must, where necessary, be designed and
constructed to permit adequate cleaning and/or disinfection.

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

may result in contamination of foodstuffs.

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

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 must be effective separation of products to protect against the risk of
contamination.

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

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

nation.

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

CHAPTER V

Equipment requirements

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

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

of contamination of the food;

(b) with the exception of non-returnable containers and packaging, be so constructed, be of such materials and be kept
if necessary,

in such good order, repair and condition as to enable them to be kept thoroughly cleaned and,
disinfected, sufficient for the purposes intended;

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

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CHAPTER VI

Food waste

1. Food waste and other refuse must not be allowed to accumulate in food rooms except so far as is unavoidable for the

proper functioning of the business.

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

3. Adequate provision must be made for the removal and storage of food waste and other refuse. Refuse stores must be
designed and managed in such a way as to enable them to be kept clean and to protect against access by pests.

Wastewater must be eliminated in a hygienic and environmentally friendly way in accordance with Community
legislation applicable to that effect, and must not constitute a source of contamination of the food, either directly or
indirectly.

CHAPTER VII

Water supply

1. There must be an adequate supply of potable water as specified in Council Directive 98/83/EC relating to the quality
of water intended for human consumption (1). This potable water must be used whenever necessary to ensure that
foodstuffs are not contaminated.

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

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

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

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

likely to contaminate the food.

CHAPTER VIII

Personal hygiene

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

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

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

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CHAPTER IX

Provisions applicable to foodstuffs

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

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

harmful deterioration and protect them from contamination.

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

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

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

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

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

and secure containers.

8. Raw materials used for the manufacture of processed products must have been produced and marketed or imported

in accordance with this Regulation.

CHAPTER X

Provisions applicable to the wrapping and packaging of foodstuffs

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

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

particular contamination arising from food, the storage environment, cleaning substances and pests.

3. In food businesses where packing operations are carried out in the presence of exposed products measures must be
taken to avoid contamination of these products. In particular, the room where packaging operations are undertaken
must be of sufficient size, construction and design to allow for hygienic operations. Packaging materials must be
assembled prior being brought into the packaging area and used without delay. Where packaging materials are to be
lined with a wrapping material this must be carried out hygienically.

4. Wrapping and packaging material must only be re-used for foodstuffs if it is made of materials that are easy to clean

and where necessary for the purposes of food hygiene, disinfect.

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CHAPTER XI

Special conditions for certain processing operations

1. Processing by heat treatment

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

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

9 if the heat treatment is applied before wrapping, measures must be taken to prevent recontamination of the food

after heating and before filling,

9 where appropriate and in particular in the case of cans and glass jars, the integrity of the container’s construction

and its cleanliness must be confirmed before filling,

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

9 in the case of a continuous heat treatment of liquid food, the mixture of heat-treated liquid with incompletely

heated liquid must be adequately prevented.

2. Smoking

9 fumes and heat must not affect other operations,

9 materials used for smoke production must be stored and used in such a way as to avoid contamination of

foodstuffs,

9 the combustion for smoke production of wood which is painted, varnished, glued or has undergone any chemical

preservation is prohibited.

3. Salting

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

CHAPTER XII

Training

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

Food business operators shall ensure that those responsible for the development and maintenance of the HACCP
system in a food business have received adequate training in the principles of HACCP.