385 tal-2005 - Regoli tal-2005 dwar l-Iġjene ta’ Oġġetti ta’ l-Ikel

L.N. 385 of 2005

VETERINARY SERVICES ACT

(CAP. 437)

Hygiene of Foodstuffs Rules, 2005

BY virtue of the powers conferred by articles 8 and 9 of the

Veterinary Services Act, the Minister for Rural Affairs and the

Environment has made the following rules>-

(1) The title to these rules is the Hygiene of Foodstuffs Rules, Title, scope and

applicability.

2005. (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.

(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.

I. 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 necessary.

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)

(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.

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

(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 (1). 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 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 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

Veterinary Services 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” shall mean 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 to these rules. 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 Adoption of specific

criteria.

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.

guides to good hygiene practice which may be used voluntarily by food

businesses as a guide to compliance with the provisions of rules 3 of

these rules.

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

in sub-rule (1) hereof 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 28 th 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

practice referred to in sub-rules (1) and (2) hereof with a view to

determining the extent to which they may be presumed to comply with

rule 3 of these rules.

(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 the attention

of the relevant food business sectors and the appropriate authorities in

their territories.

Member States shall, if they consider it appropriate, Application of

recommend food business operators to apply the European Standards 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, National Provisions.

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 subparagraph, 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 this Directive and, where appropriate, any

provisions laid down pursuant to Article 4 of this 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 this 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

foodstuffs imported into the Community are carried out 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 Threats to human

health.

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 30 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 30 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 Commission thereof

without delay and give reasons for its 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 the control of hygiene and shall notify the Commission

about them.

Amendments to references to international standards, such

as those of the Codex Alimentarius, contained in this rule, may be

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

Standing Committee

(1) The Commission shall be assisted by the Standing

Committee on Foodstuffs (hereinafter referred to as “the 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.