HYGIENE OF FOODSTUFFS RULES

SUBSIDIARY LEGISLATION 437.90

HYGIENE OF FOODSTUFFS RULES

25th November, 2005

LEGAL NOTICE 385 of 2005.

(1)

The title of these rules is the Hygiene of Foodstuffs

Rules.

(2) The scope of these rules is to implement the provisions

found under European Union Council Directive 93/43/EEC

regarding the hygiene of foodstuffs, hereinafter referred to as "the

Directive".

(3) These rules aim at laying down the general rules of hygiene

for foodstuffs and the procedures for verification of compliance

with these rules.

Preface

1. Chapters V to X of this Schedule apply throughout all stages after primary

production during preparation, processing, manufacturing, packaging, storing,

transportation, distribution, handling and offering for sale or supply to the consumer.

The remaining chapters of the Schedule apply as follows

-

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

-

Chapter II: to all rooms where food is prepared, treated or processed

except those covered by Chapter III and excluding dining areas,

-

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

-

Chapter IV: to all transportation.

2. The terms 'where appropriate' and 'where necessary' used in this Schedule

mean for the purposes of ensuring the safety and wholesomeness of foodstuffs.

General requirements for food premises (other than those specified in

Chapter III)

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

condition.

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

(a) permit adequate cleaning and/or disinfection;

(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 operations by foodstuffs, equipment,

materials, water, air supply or personnel and external sources of

contamination such as pests;

(d) provide, where necessary, suitable temperature conditions for the

hygienic processing and storage of products.

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 lead

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. When necessary, the

provisions 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 air flow 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. All sanitary conveniences within food premises 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.

9. Adequate changing facilities for personnel must be provided where

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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

(a) floor surfaces must be maintained in a sound condition and they must be

easy to clean and, where 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 they must be

easy to clean and, where 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 designed, constructed and

finished to prevent the accumulation of dirt and to 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 contact with food must be

maintained in a sound condition and be easy to clean and, where

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. Where necessary, adequate facilities must be provided for the cleaning and

disinfecting of work tools and equipment. 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. When appropriate, adequate provision must be made for any necessary

washing of the food. 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.

III Requirements for movable and/or temporary premises (such as marquees,

market stalls, mobile sales vehicles) premises used primarily as a private dwelling

house, 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 practicable.

HYGIENE OF FOODSTUFFS

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, where 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;

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

disinfecting of work utensils and equipment;

(d) adequate provision must be made for the cleaning of foodstuffs;

(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, so far as is reasonably

practicable, the risk of contamination.

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 'for foodstuffs only'.

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, where necessary, to protect against the risk

of contamination.

4. Where conveyances and, or containers have been used for transporting

anything other than foodstuffs or for transporting 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 minimize the risk of contamination.

6. Where necessary, conveyances and, or containers used for transporting

foodstuffs, must be capable of maintaining foodstuffs at appropriate temperatures

and, where necessary, designed to allow those temperatures to be monitored.

V

Equipment requirements

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

kept clean and

HYGIENE OF FOODSTUFFS

(a) be so constructed, be of such materials and be kept in such good order,

repair and condition as to minimize 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 in such good order, repair

and condition as to enable them to be kept thoroughly cleaned and,

where necessary, disinfected, sufficient for the purposes intended;

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

surrounding area.

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 and other refuse must be deposited in closable containers unless

food business operators can satisfy the competent authority that other types of

containers used are appropriate. These containers must be of an appropriate

construction, kept in sound condition and where necessary be easy to clean and

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 and against

contamination of food, drinking water, equipment or premises.

VII

Water supply

1. There must be an adequate supply of potable water as specified in Council

Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for

human consumption. This potable water must be used whenever necessary to ensure

foodstuffs are not contaminated.

2. When appropriate, ice must be made from water which meets the

specifications referred to in Directive 80/778/EEC. This ice must be used whenever

necessary to ensure foodstuffs are not contaminated. It must be made, handled and

stored under conditions which protect it from all contamination.

3. Steam used directly in contact with food must not contain any substance

which presents a hazard to health or is likely to contaminate the product.

4. Water unfit for drinking used for the generation of steam, refrigeration, fire

control and other similar purposes not relating to food, must be conducted in

separate systems, readily identifiable and having no connection with, nor any

possibility of reflux into, the potable water systems.

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 appropriate,

protective clothing.

2. No person, known or suspected to be suffering from, or 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 with diarrhoea, shall be permitted to work

in any food handling area in any capacity in which there is any likelihood of directly

or indirectly contaminating food with pathogenic micro-organisms.

IX

Provisions applicable to foodstuffs

1. No raw materials or ingredients shall be accepted by a food business if they

HYGIENE OF FOODSTUFFS

are known to be, or might reasonably be expected to be, so 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 the establishment shall be kept in

appropriate conditions designed to prevent harmful deterioration and to protect them

from contamination.

3. All food which is handled, stored, packaged, displayed and transported shall

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. In particular, food must be so

placed and, or protected as to minimize any risk of contamination. 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.

Consistent with food safety, limited periods outside temperature control are

permitted where necessary to accommodate the practicalities of handling during

preparation, transport, storage, display and service of food.

5. When foodstuffs are to be held or served at chilled temperatures they must

be cooled as quickly as possible following the final 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. Hazardous and, or inedible substances, including animal feedstuffs, shall be

adequately labelled and stored in separate and secure containers.

X

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.

(1) For the purposes of these rules, the following

definitions shall apply

"the Act" means the Veterinary Services Act;

"the Commission" means the European Commission;

"the Community" means the European Community as established

under the Treaty establishing the European Community;

"the competent authority" means the Veterinary Services within

the territory of Malta as provided under article 2 of the Act;

"food business" means any undertaking, whether for profit or not

and whether public or private, carrying out any or all of the

following: preparation, processing, manufacturing, packaging,

storing, transportation, distribution, handling or offering for sale or

supply of foodstuffs;

"food hygiene", hereinafter called "hygiene", means all measures

necessary to ensure the safety and wholesomeness of foodstuffs.

The measures shall cover all stages after primary production (the

latter including, for example, harvesting, slaughter and milking),

during preparation, processing, manufacturing, packaging, storing,

transportation, distribution, handling and offering for sale or supply

to the consumer;

"Member State" means a State which is a Member within the

European Community;

"wholesome food" means food which is fit for human

consumption as far as hygiene is concerned.

(1) The

preparation,

processing,

manufacturing,

packaging, storing, transportation, distribution, handling and

offering for sale or supply of foodstuffs shall be carried out in a

hygienic way.

(2) Food business operators shall identify any step in their

activities which is critical to ensuring food safety and ensure that

adequate safety procedures are identified, implemented, maintained

and reviewed on the basis of the following principles, used to

develop the system of HACCP (Hazard analysis and critical control

points)

(i)

analysing the potential food hazards in a food business

operation,

(ii) identifying the points in those operations where food

hazards may occur,

(iii) deciding which of the points identified are critical to

food safety, the ‘critical points’,

(iv) identifying and implementing effective control and

monitoring procedures at those critical points,

(v) reviewing the analysis of food hazards, the critical

control points and the control,

(vi) monitoring procedures periodically and whenever the

food business operations change.

(3) Food business operators shall comply with the rules of

hygiene as listed in the Schedule. Derogations from certain

provisions of the said Schedule may be granted according to the

procedure laid down in Article 14 of the Directive.

Without prejudice to more specific rules of the European

Union, microbiological criteria and temperature control criteria for

certain classes of foodstuffs may be adopted in accordance with the

procedure laid down in Article 14 of the Directive and after

consulting the Scientific Committee for Food set up by Decision

74/234/EEC.

(1) Member States shall encourage the development of

guides to good hygiene practice which may be used voluntarily by

food businesses as a guide to compliance with the provisions of

rule 3.

(2) Where the guides to good hygiene practice referred to in

sub-rule (1) are developed, they shall be developed as follows

(i)

by food business sectors and representatives of other

interested parties, such as appropriate authorities and

consumer groups,

(ii) in consultation with interests substantially affected,

including the competent authorities,

(iii) where appropriate, having regard to the Recommended

International Code of Practice, General Principles of

Food Hygiene of the Codex Alimentarius.

(3) The guides referred to in sub-rules (1) and (2) may be

developed under the aegis of a national standards institute referred

to in list 2 of the Schedule to Council Directive 83/189/EEC of the

28th March 1983 laying down a procedure for the provision of

information in the field of technical standards and rules.

(4) Member States shall assess the guides to good hygiene

pr actice r eferr ed to in sub-ru les (1) and (2) with a view to

determining the extent to which they may be presumed to comply

with rule 3.

(5) Member States shall forward to the Commission those

guides to good hygiene practice which they presume to comply

with Article 3 of the Directive. The Commission shall make these

guides available to the Member States.

(6) Where one or more Member States, or the Commission,

consider that, for the purposes of harmonization, there may be a

need for guides to good hygiene practice to be developed on a

European basis (hereafter referred to as ‘European guides to good

hygiene practice’), the Commission shall consult Member States in

the framework of the Standing Committee on Foodstuffs in

accordance with Article 14 of the Directive. The object of this

consultation shall be to consider the case for such voluntary guides

in the sectors or activities concerned, and, where such guides are

considered necessary

(i)

to indicate the intended scope, subject matter and

timetable for development of such voluntary guides,

taking into account the time needed for consultation

with interests substantially affected by them, and

(ii) to refer such voluntary guides for development and, or

assessment under the aegis of a European standards

institute.

(7) In developing the European guides to good hygiene

practice referred to in sub-rule (6), all necessary measures shall be

taken in order to

(i)

ensure that such guides are developed by

representatives of food business sectors and

representatives of other interests substantially

affected, such as, for example, the competent

authorities and consumer groups,

(ii) ensure that the contents of such guides comply with

the provisions of rule 3 of these rules and, where

appropriate, have regard to the Recommended

International Code of Practice, General Principles of

Food Hygiene of the Codex Alimentarius,

(iii) ensure that the contents of such guides are practicable

for the food industry sectors to which they refer

throughout the Community,

(iv) ensure that the relevant guides to good hygiene

practice drawn up in accordance with sub-rules (1) and

(3) are taken into account,

(v) ensure that all interests substantially affected by such

guides, including Member States, are consulted and

their comments taken into account.

(8) The titles and references of European guides to good

hygiene practice developed in accordance with the procedure in

paragraphs 6 and 7 Article 5 of the Directive are published in the C

series of the Official Journal of the European Communities.

Member States shall ensure that such published guides are drawn to

th e a t te n ti o n o f t he r e l e v a n t f oo d bu s in es s sec t or s a n d t h e

appropriate authorities in their territories.

Member States shall, if they consider it appropriate,

reco mm en d fo od bu siness operators to apply the European

Standards of the EN 29000 series in order to implement the general

rules of hygiene and the guides to good hygiene practice.

(1) Subject to the Treaty, Member States may maintain,

amend or introduce national hygiene provisions that are more

specific than those laid down by the Directive, provided that such

provisions

(i)

are not less stringent than those given in the Schedule,

(ii) do not constitute a restriction, hindrance or barrier to

trade in foodstuffs produced in accordance with the

Directive.

(2) Until detailed provisions have been laid down in

accordance with Article 4 of the Directive, Member States may

maintain, amend or introduce the relevant national provisions,

subject to the Treaty.

(3) Should a Member State deem it necessary, in the cases

provided for in paragraphs 1 and 2 of Article 7 of the Directive, to

adopt new legislation or amend existing legislation, it shall

communicate to the Commission and the other Member States the

measures envisaged and give the reasons justifying them. The

Commission shall consult the Member States within the Standing

Committee on Foodstuffs set up by Decision 69/414/EEC if it

considers such consultation to be useful or if a Member State so

requests.

The Member State may take the envisaged measures only

three months after such communication and provided that it has not

received an opinion to the contrary from the Commission.

In the latter event, before the expiry of the period referred

to in the second paragraph, the Commission shall initiate the

procedure provided for in Article 14 of the Directive in order to

determine whether the envisaged measures may be implemented

subject, if necessary, to the appropriate amendments.

(1) The competent authorities shall carry out controls in

accordance with Directive 89/397/EEC in order to ensure that the

provisions of Article 3 of the Directive and, where appropriate, any

provisions laid down pursuant to Article 4 of the Directive are

being complied with by food businesses. In doing so, due

consideration shall be given to the guides to good hygiene practice

referred to in Article 5 of the Directive, where they exist.

(2) Inspections by competent authorities shall include a general

assessment of the potential food safety hazards associated with the

business. Competent authorities shall pay particular attention to

critical control points identified by food businesses to assess

whether the necessary monitoring and verification controls are

being operated.

Member States shall provide that all food premises are

inspected at a frequency which has regard to the risk associated

with the premises.

(3) The competent authorities shall ensure that controls on

fo odst uffs im po rt ed int o the Co mm un it y a re carr ied o ut in

accordance with Directive 89/397/EEC for the purpose of ensuring

that the relevant provisions of Article 3 and, where appropriate, any

provisions laid down pursuant to Article 4, are being observed.

(1) If while carrying out the controls referred to in rule 8,

the competent authorities ascertain that failure to comply with the

provisions of rule 3 or, where appropriate, any provisions laid

down pursuant to rule 4 might result in risks to the safety or

wholesomeness of foodstuffs, they shall take appropriate measures

which may extend to the withdrawal and, or the destruction of the

foodstuff or to the closure of all or part of the undertaking for an

appropriate period of time.

In determining the risk to food safety or wholesomeness

regard shall be had to the nature of the food, the manner in which it

is handled and packed and any process to which the food is

subjected before supply to the consumer and the conditions under

which it is displayed and, or stored.

(2) Member States shall take the necessary measures to ensure

that any natural or legal person affected by the control has a right

of appeal against the measures taken by the competent authority

following the control.

(1) If a hygiene problem likely to pose a serious risk to

human health arises or spreads in the territory of a third country,

the Commission, either on its own initiative or at the request of a

Member State, shall take the following measures without delay,

depending on the seriousness of the situation

(i)

suspend imports from all or part of the third country

concerned and, where necessary, from the transit third

country, and, or

(ii) lay down special conditions for foodstuffs from all or

part of the third country concerned.

(2) The Commission may, in the case provided for in sub-rule

(1), take interim protective measures regarding the foodstuffs

concerned.

(3) Except in an emergency, the Commission shall consult the

Member States before taking the measures referred to in sub-rules

(1) and (2).

(4) The Commission shall notify the Council and the Member

States without delay of any decision taken pursuant to sub-rules (1)

and (2).

Any Member State may refer the Commission’s decision to

the Council within thirty days of the notification referred to in sub-

rule (1). The Council, acting by a qualified majority, may confirm,

amend or revoke the decision adopted by the Commission. If the

Council has not taken a decision within thirty days, the decision of

the Commission is deemed to be revoked.

(5) Where a Member State officially informs the Commission

of the need to take safeguard measures and the Commission has not

had recourse to the provisions of sub-rules (1) and (2), that Member

State may take interim protective measures with regard to imports

of the foodstuffs in question.

When a Member State takes interim protective measures, it

shall inform the other Member States and the Commission.

Within ten working days, the Commission shall put the

matter before the Standing Committee on Foodstuffs in accordance

with the procedure laid down in rule 14 with a view to the

extension, amendment or abrogation of the national interim

protective measures.

(1) Where as a result of new information or of a

reassessment of existing information, Malta has good reason to

suspect that application of the detailed provisions laid down

pursuant to rule 4 constitutes a health risk, the competent authority

may temporarily suspend or restrict application of the provisions in

question in Malta. It shall inform the other Member States and the

Comm ission thereof without delay and gi ve reasons for i ts

decision.

(2) The Commission shall examine the reasons given by the

Member State referred to in sub-rule (1) as soon as possible in the

Standing Committee on Foodstuffs and shall deliver its opinion and

take any necessary measures in accordance with the procedure laid

down in rule 14.

Member States shall designate the competent authorities

responsible for th e control of hygiene and shal l no t if y t he

Commission about them.

Amendments to references to international standards, such

as those of the Codex Alimentarius, contained in these rules, may

be adopted in accordance with the procedure laid down in rule 14.

(1) The Commission shall be assisted by the Standing

C o m m i t t e e o n F o o d s t u ff s ( h e r e i n a f t e r r e f e r r e d t o a s " t h e

Committee").

(2) The representative of the Commission shall submit to the

Committee a draft of the measures to be taken. The Committee

shall deliver its opinion on the draft within a time limit which the

chairman may lay down according to the urgency of the matter. The

opinion shall be delivered by the majority laid down in Article

148(2) of the Treaty in the case of decisions which the Council is

required to adopt on a proposal from the Commission.

(3) The votes of the representatives of the Member States

within the Committee shall be weighted in the manner set out in

that Article. The chairman shall not vote.

(4) The Commission shall adopt the measures envisaged if they

are in accordance with the opinion of the Committee.

(5)

If the measures envisaged are not in accordance with the

opinion of the Committee, or if no opinion is delivered, the

Commission shall, without delay, submit to the Council a proposal

relating to the measures to be taken. The Council shall act by a

qualified majority.

(6) If, three months from the date of referral to the Council, the

Council has not acted, the proposed measures shall be adopted by

the Commission, save where the Council has decided against the

said measures by a simple majority.