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HYGIENE OF FOOD REGULATIONS

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Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

SUBSIDIARY LEGISLATION 449.31

HYGIENE OF FOOD REGULATIONS

1st October, 2002;

1st July, 2003

LEGAL NOTICE 264 of 2002, as amended by Legal Notices 137 of 2003,

and 105 and 447 of 2004.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

The title of these regulations is the Hygiene of Food

Regulations.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

(Regulation 8)

This schedule provides the regulatory framework for ensuring

the hygiene and safety of food and shall be applicable as follows

-

Part I to all food premises except those covered by Part

III;

-

Part II to all rooms where food is prepared, treated or

processed except those covered by Part III and

excluding dining areas;

-

Part III to those premises listed in the heading to that

Part;

-

Part IV to all transportation; and

Parts V to IX of this Schedule apply throughout all

stages after primary production during preparation,

processing, manufacturing, packaging, storing,

transportation, and distribution, handling and offering

for sale or supply to the consumer.

PART I

GENERAL REQUIREMENTS FOR FOOD PREMISES

(OTHER THAN THOSE SPECIFIED IN PART III)

1. The requirements of this Part of the Schedule apply to all

food premises except those specified in Part III below.

Food premises must be kept clean and maintained in a state

of good repair and condition.

3. The layout, design, construction and size of food premises

(a) permit adequate cleaning

or,

where

relevant,

disinfecting of all areas;

(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 any surface;

(c) facilitate and permit the implementation of good food

hygiene practice or standards for assuring food

hygiene;

(d) protect against cross contamination between and

during operations by food, equipment, materials,

water, air supply or personnel and external sources of

contamination such as pests;

(e) provide, where necessary, suitable temperature

conditions for the hygienic processing, handling and

storage of products.

4. (1) An adequate number of washbasins designated for

cleaning hands must be installed in the food premises

Provided that these are located to the satisfaction of the health

authority

Provided also that these washbasins are supplied with cold

running water and hot running water that is at a suitably controlled

temperature.

(2) Suitable materials for cleaning hands and for hygienic

drying of hands must be available at all times.

(3) An adequate number of flush lavatories must be available

and connected to an effective drainage system to the satisfaction of

the health authority or in compliance to any other law.

(4) Sanitary conveniences must not lead directly into any room

in which food is stored, processed or handled.

5. (1) The food premises must have suitable provisions and

facilities for washing food.

When determined by the health authority as necessary, these

provisions and facilities must be separate from the hand-washing

facilities described in these regulations.

(2) Every washbasin or any other facility provided for the

washing of food must have an adequate supply of cold running

potable water and hot potable running water that is at a suitably

controlled temperature to the satisfaction of the health authority.

(3) Every washbasin or any other facility provided for the

washing of food must be kept clean.

(4) Materials and tools for hygienic cleaning of food must be

available for use at all times and located in close proximity to every

washbasin or other facility for the washing of food.

6. (1) There must be suitable and sufficient means of natural

or mechanical ventilation in all rooms of the food premises and to

the satisfaction of the health authority or in accordance to any other

law or standard

Provided that the health authority may establish different

ventilation requirements for different areas or rooms of a food

premises.

(2) Mechanical air flow from a contaminated area to a clean

area must be avoided.

(3) Ventilation systems must be so constructed as to enable

filters and other parts requiring cleaning or replacement to be

readily accessible and cleaned.

7. All areas of the food premises must have adequate natural

or artificial lighting to the satisfaction of the health authority

Provided that the health authority may establish different

lighting requirements for different rooms of the same premises.

8. Drainage facilities must be adequate for the purpose

intended and must be designed and constructed to avoid the risk of

contamination of food.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

These regulations have the scope of assuring food hygiene

at, and are applicable to, all stages after primary production, during

preparation, processing, manufacturing, packaging, storing,

transportation, distribution, handling or offering for sale or supply

to the consumer.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

In these regulations, unless the context otherwise requires

"Act" means the Food Safety Act;

"authorised officer" has the same meaning as is assigned to it in

the Act;

"food" has the same meaning as is assigned to it in the Act;

"food business" has the same meaning as is assigned to it in the

Act;

"food hygiene", or "hygiene", means all measures necessary to

ensure the safety and wholesomeness of food at all stages after

primary production, during preparation, processing, manufacturing,

packaging, storing, transportation, distribution, handling or

offering for sale or supply to the consumer;

"Minister" means the Minister responsible for public health;

"proprietor", in relation to a food business, means the person or

persons by whom the business is carried on and includes owners

and occupiers of premises, licence holders for the business or

premises, and the persons who appear on the register of food

premises;

"primary production" includes harvesting, slaughtering and

milking;

"sale" has the same meaning as is assigned to it in the Act and

includes an act to offer, expose, advertise or keep for sale and to

supply by way of compensation or otherwise;

"wholesome food" means food which is fit for human

consumption as far as hygiene is concerned.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

(1) In the enforcement of compliance with and execution

of these regulations, the health authority shall

(a) ensure that inspections include a general assessment of

the potential food safety hazards associated with the

business;

(b) pay particular attention to the critical points identified

by food businesses to assess whether the necessary

controls are being monitored and verification controls

are being operated; and

(c) ensure that food premises are inspected with a

frequency which has regard to the risk associated with

the business carried on from those premises.

(2) In determining a risk to food safety 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 or stored.

(3) If, in the opinion of the health authority, failure to comply

w i th t h e s e r e g u l at i o n s m ay r es u l t i n r i s k s t o t h e s af et y o r

wholesomeness of food, it shall take all the appropriate measures to

prevent or minimize such risks, including the withdrawal of the

food or the closure of all or part of a food business for such period

as may be required to secure compliance with the provisions of

these regulations.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

(1) The health authority may, by notice in the Gazette,

establish the temperature control or microbiological control criteria

for certain classes of food.

(2) The proprietor of a food business shall comply with any

order made by the health authority under sub-regulation (1).

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

(1) Without prejudice to specific requirements set out in

these regulations, the proprietor of a food business shall ensure that

the preparation, processing, manufacturing, packaging, storing,

transportation, distribution, handling and offering for sale or supply

of food, shall be carried out in a hygienic way and in accordance

with these regulations.

(2) The proprietor shall also adopt such appropriate working

methods as will ensure the safety of the food. For such purpose,

compliance with any guide -

(a) published by the Food Safety Commission in terms of

article 7(1)(i) of the Act, or

(b) approved and

recognized

by

the

Food

Safety

Commission,

shall be deemed, to the extent provided in the guide, to constitute

appropriate working methods.

(3) Where the guides referred to in sub-regulation (2)(b) are

developed, they shall be developed as follows

(a) by food business sectors and representatives of other

interested parties, such as appropriate authorities and

consumer groups,

(b) in consultation with interests substantially affected,

including the Food Safety Commission,

(c) where appropriate, having regard to the Recommended

International Code of Practice, General Principles of

Food Hygiene of the Codex Alimentarius.

(4) The Food Safety Commission, prior to approving and

recognizing any guide referred to in sub-regulation (2)(b), shall

assess it with a view to determining the extent to which it may be

presumed to comply with regulation 7.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

The proprietor of a food business shall ensure that any

stage in the activities of his food business which is critical to

ensuring food safety is identified and ensure that adequate safety

procedures are identified, implemented, maintained and reviewed

on the basis of a system of Hazard Analysis Critical Control Points

(HACCP) that comprises the activities set out below

(a

the analysis of the potential food hazards in a food

business operation;

(b) the identification of the points in those operations

where food hazards may occur;

(c) the determination of those points that are critical to

food safety - hereinafter known as the critical points;

(d) the identification and implementation of elective

control and monitoring procedures at those critical

control points; and

(e) the periodical review of the analysis of food hazards,

the critical control points and the control and

monitoring procedures or whenever the food business

operations change.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

(1) Subject to sub-regulation (2), the proprietor of a food

business shall comply with the provisions set out in the Schedule.

(2) The proprietor of a food business may derogate from

compliance with the provisions of hygiene as set in the Schedule

provided that such proprietor does so in accordance with

Comm ission Directive 96/3/E C as amended by Com mission

Directive 2004/4/EC (corrected version) or in accordance with

Commission Directive 98/28/EC.

HYGIENE OF FOOD

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

Adequate changing facilities for personnel must be

p rov ided where th e h ealth autho rity estab lish es th at this is

necessary

Provided that the need for such facilities shall be made that gives

due consideration to the nature of the food or the process of

handling, storage or processing of food.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

(1) The requirements of this Part apply to rooms where

food is prepared, treated or processed, excluding dining areas and

those premises specified in Part III.

(2)

Floor and wall surfaces must

(a) be maintained in a sound condition; and

(b) be easy to clean and, where necessary, disinfect.

(3) Without prejudice to any other law or regulation, floors and

wall shall be covered with impervious, non-absorbent, washable

and non-toxic materials

Provided that food business operators may use other materials

and can satisfy the health authority that these materials are

appropriate.

(4) Where appropriate, floors must allow adequate surface

drainage so as to prevent the accumulation of water in any area.

(5) Ceilings and overhead fixtures must be designed in such a

fashion, and constructed and finished in such a manner as to

prevent the accumulation of dirt and to reduce to a minimum

condensation, the growth of undesirable moulds and the shedding

of particles.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

Windows and other openings must be constructed to

prevent the accumulation of dirt. Those which can be opened to the

outside environment must be fitted with insect-proof screens which

can be easily removed for cleaning

Provided that the health authority may authorise the use of other

insect control mechanisms in lieu of the requirement for an insect-

proof screen.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

(1) Doors must be

(a) maintained in a sound condition; and

(b) easy to clean and, where necessary, disinfect.

(2) Doors shall be made of impervious, non-absorbent,

washable and non-toxic materials

Provided that food business operators may use other materials

and can satisfy the health authority that these materials are

appropriate.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

(1) Surfaces, including surfaces of equipment that come in

contact with food must be

(a) maintained in a sound condition; and

(b) be easy to clean and, where necessary, disinfect.

(2)

Surfaces shall be smooth, impervious, washable and non-

toxic.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

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.

Laws of Malta — Subsidiary Legislation 449.31 — HYGIENE OF FOOD REGULATIONS

When appropriate, adequate facilities and tools for the

hygienic food. washing in accordance to paragraph 5 shall be made

for readily available.

PART II

SPECIFIC REQUIREMENTS IN ROOMS WHERE FOOD IS

PREPARED, TREATED OR PROCESSED

(EXCLUDING DINING AREAS AND THOSE PREMISES

SPECIFIED IN PART III)

1. The requirements of this Part apply to rooms where food is

prepared, treated or processed, excluding dining areas and those

premises specified in Part II.

2. (1)

Floor and wall surfaces must

(a) be maintained in a sound condition; and

(b) be easy to clean and, where necessary, disinfect.

(2) Without prejudice to any other law or regulation, floors and

wall shall be covered with impervious, non-absorbent, washable

and non-toxic materials

Provided that food business operators may use other materials

and can satisfy the health authority that these materials are

appropriate.

(3) Where appropriate, floors must allow adequate surface

drainage so as to prevent the accumulation of water in any area.

3. Ceilings and overhead fixtures must be designed in such a

fashion, and constructed and finished in such a manner as to

prevent the accumulation of dirt and to reduce to a minimum

condensation, the growth of undesirable moulds and the shedding

of particles.

4. Windows and other openings must be constructed to

prevent the accumulation of dirt. Those which can be opened to the

outside environment must be fitted with insect-proof screens which

can be easily removed for cleaning; where open windows would

result in contamination of food, windows must remain closed and

fixed during production

Provided that the health authority may authorise the use of other

insect control mechanisms in lieu of the requirement for an insect-

proof screen.

5. (1)

Doors must be

(a

maintained in a sound condition; and

(b) easy to clean and, where necessary, disinfect.

(2

Doors shall be made of impervious, non-absorbent,

washable and non-toxic materials

Provided that food business operators may use other materials

and can satisfy the health authority that these materials are

appropriate.

6. (1)

Surfaces, including surfaces of equipment that come in

contact with food must be

(a) maintained in a sound condition; and

(b) easy to clean and, where necessary, disinfect.

(2)

Surfaces shall be smooth, impervious, washable and non-

toxic.

7. 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.

8. When appropriate, adequate facilities and tools for the

hygienic washing in accordance with paragraph 5 of Part I of this

Schedule shall be made readily available.

PART 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. The requirements of this Part of this Schedule shall apply

to moveable or temporary premises including marquees, market

stalls, mobile sales vehicles, premises used primarily as a private

dwelling house, premises used occasionally for catering purposes

and vending machines.

2. (1) The proprietor of a food business which is carried out

from a food premises referred to in paragraph 1 and from vending

machines shall ensure that the provisions in sub-paragraph (2) are

complied with.

(2) 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 food and harbouring

pests or growth of undesirable moulds, so far as is reasonably

practicable.

3. 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 as established by the health authority

Provided that the specifications for such facilities shall be made

in a manner that gives due consideration to the nature of the food or

the process of handling, storage or processing of food.

4. (1) Surfaces, including surfaces of equipment that come in

contact with food must be

(a) maintained in a sound condition; and

(b) be easy to clean and, where necessary, disinfect.

(2)

Surfaces shall be smooth, impervious, washable and non-

toxic.

5. Adequate provision must be made for the cleaning and,

where necessary, disinfecting of work utensils and equipment to the

satisfaction of the health authority

Provided that the health authority shall act in a manner that gives

due consideration to the nature of the food or the process of

handling, storage or processing of food.

6. Adequate provision must be made for the cleaning of food

to the satisfaction of the health authority

Provided that the health authority shall act in a consistent manner

and giving due consideration to the nature of the food or the

process of handling, storage or processing of food.

7. An adequate supply of hot and cold potable water must be

available at all times and to the satisfaction of the health authority

Provided that the health authority shall act in a manner that gives

due consideration to the nature of the activity or premises.

8. Adequate arrangements or facilities for the hygienic

storage and disposal of any substance or waste, whether in the

liquid or solid form must be available at all times to the satisfaction

of the health authority

Provided that the health authority shall act in a manner that gives

due consideration to the nature of the substance or waste to be

disposed of and in accordance to the provision of any other law.

9. Adequate facilities or arrangements for maintaining and

monitoring suitable food temperature conditions must be available

at all times of operation and to the satisfaction of the health

authority

Provided that the health authority shall act in a manner that gives

due consideration to the nature of the activity or premises.

10. Food must be placed as to avoid, so far as is reasonably

practicable, the risk of contamination.

11. The premises and all its equipment or facilities shall,

where necessary, be drained to the satisfaction of the health

authority.

PART IV

TRANSPORT

1. Unless otherwise provided for by any other Act, this Part

of this Schedule shall apply to all means and equipment used for

the transport of food.

2. (1) The person responsible for the transport of the food

shall take all necessary measures to ensure that the means of

transport and equipment used in the transport of food shall protect,

assure and preserve the hygiene of the food being transported.

(2) Conveyances or containers used for transporting food must

be kept clean and maintained in good repair and condition in order

to protect the transported food from contamination and must, where

necessary, be designed and constructed to permit adequate cleaning

or disinfection.

3. Containers in vehicles must not be used for transporting

anything other than food where this may result in the contamination

of food.

4. (1) Bulk food in liquid, granular or powder form must be

transported in containers or tankers specifically designed and

reserved for the transport of food.

(2) Such containers must be marked in a clearly visible and

indelible fashion, to show that they are used for the transport of

food.

5. Where containers are used for transporting anything in

addition to food or for transporting different food at the same time,

there must be effective separation of the different products, if this

separation is considered necessary in order to protect against risk of

cross-contamination.

6. Where containers have been previously used for

transporting anything other than food or for transporting different

food to that being transported at the time, the container must be

effectively cleaned between loads to avoid risk of cross-

contamination.

7. Food and the container in which the food is stored for

transport must be also placed and protected as to minimise the risk

of contamination.

8. Where necessary, containers used for transporting food

must be capable of maintaining food at appropriate temperatures

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

monitored.

PART V

EQUIPMENT REQUIREMENTS

1. This Part of this Schedule shall apply to all articles, fittings

and equipment with which food comes into contact at any time

during its storage, handling, processing, transport or sale.

2. All articles, fittings and equipment with which food comes

into contact, shall be

(a) kept clean;

(b) constructed or made of such materials and kept in such

a state of order, repair and condition so as to prevent or

minimise any risk of contamination of the food;

(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 thoroughly cleaned and, where

necessary, disinfected, sufficient for the purposes

intended;

(d) be installed in such a manner as to allow adequate

cleaning of the surrounding area.

PART VI

FOOD WASTE

1. This part of this Schedule shall apply to the proper keeping

and handling of food waste in any food premises.

2. Food waste and other refuse must not be allowed to

accumulate in any food premises or area in the food premises that is

not specifically designed and designated for the purpose of storing

food waste.

3. Food waste and other refuse must be deposited in a

container that is of an appropriate construction, kept in sound

condition, may be closed and, where necessary, be easy to clean or

disinfect and to the satisfaction of the health authority

Provided that the health authority shall act in a manner that gives

due consideration to the nature of the activity or premises.

4. (1) Any food premises must make adequate provision for

the periodical removal and transitory storage of food waste and

other refuse to the satisfaction of the health authority

Provided that the health authority shall act in a manner that gives

due consideration to the nature of the activity or premises.

(2) Food premises may have a room or an area that is designed

for the storage of refuse on the premises and such a room or area

must be designed and managed in such a way as to enable them to

b e k ep t c lean , p r ev en t acce ss b y p es ts , pr o t ect ag ai n st th e

contamination of food, drinking water, equipment or any other area

of the food premises

Provided that the area or room shall be used only for the purpose

of storage of refuse.

PART VII

WATER SUPPLY

1. This part of this Schedule shall apply to all food premises

and concerns the availability of potable water in these premises.

2. All food premises must have an adequate supply of potable

water at all times of operation.

3. Ice that comes in contact with food or that is intended for

human consumption shall be

(a) produced from potable water;

(b) produced, handled and stored under conditions which

protect it from all contamination.

4. Steam that is used or otherwise intended to come in contact

with food must not contain any substance which presents or may

present a hazard to health or is likely to contaminate the food.

5. Water unfit for drinking used for the generation of steam,

refrigeration, fire control or any other similar purposes not relating

to food, must be made available and accessible to the food premises

or any area therein through a separate system from that used for

potable water and this system shall be readily identifiable and have

no connection with, nor have any possibility of reflux into, the

potable water systems.

PART VIII

PERSONAL HYGIENE

1. This part of this Schedule shall apply to all food handlers

and concerns the assurance of suitable levels of personal hygiene at

all times that the food handler is in contact, or may come in contact,

with any food where "food handler" means any person engaged in

the preparation, manufacture and treatment in terms of the Act, in a

food business, whether for profit or not, and who handles or

prepares food intended for human consumption.

2. Any food handler shall maintain a high degree of personal

cleanliness and shall wear suitable, clean and, where appropriate,

protective clothing at all times during which he may come in

contact with any food and to the satisfaction of the health authority

Provided that any requirement for personal hygiene shall be

made in a manner that gives due consideration to the nature of the

food or the process of handling, storage or processing of food or the

nature of the food business.

3. (1) 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.

(2) Any food handler who knows or suspects that he is

suffering form any condition as described in sub-paragraph (1),

shall inform his employer and shall not handle any food until such

condition or suspicion is no longer present.

PART IX

PROVISIONS APPLICABLE TO FOOD

1. This part of this Schedule shall apply to all food and

concerns its proper storage.

2. No raw materials or ingredients shall be accepted by a food

business if they are known to be, or reasonably suspected to be,

contaminated with any parasite, pathogen micro-organism or toxic.

decomposed or foreign substance that would or may result in

m a k i n g t h e f o o d t h a t , a f t e r u n d e rg o i n g n o r m a l s o r t i n g o r

preparation or processing procedures hygienically applied by food

businesses, they would still be unfit for human consumption.

3. Raw materials and food ingredients stored in the

establishment shall be kept in appropriate conditions that are

designed to prevent harmful deterioration and to protect them from

contamination.

4. 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 minimise any risk of contamination.

5. Adequate procedures must be in place to ensure that the

presence of pests in any food premises is prevented and controlled

to the satisfaction of the health authority.

6. 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. However, and consistent

with measures that maintain food safety, the keeping of these foods

for limited periods outside temperature control are permitted where

necessary to accommodate the practicalities of handling during

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

7. When food is to be held or served at chilled temperatures it

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.

8. Hazardous and / or inedible substances, including animal

feedstuffs, shall be adequately labelled and stored in separate and

secure containers.

PART 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.

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