Annexes to COM(2000)438-1 - Hygiene of foodstuffs

Please note

This page contains a limited version of this dossier in the EU Monitor.

dossier COM(2000)438-1 - Hygiene of foodstuffs.
document COM(2000)438 EN
date April 29, 2004
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,

- adopting practices and measures to ensure that food and food sources are produced under appropriate hygienic conditions,

- adopting measures with regard to hazards from the environment,

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

- 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:

- implementing suitable cleaning and disinfection procedures for animal housing, equipment, premises, transport crates and vehicles, etc.,

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

- proper use of veterinary medicinal products and feed additives,

- proper disposal of dead animals, waste and litter,

- implementing effective pest-control programmes,

- isolating diseased animals,

- the cleanliness of slaughter animals,

- Protective measures to prevent the introduction of contagious diseases or diseases transmissible to humans,

- the possible hazards associated with feedingstuffs,

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

- 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:

- the nature and origin of feedingstuffs,

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

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

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

- 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,

- 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:

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

- appropriate production, handling, storage and transport methods,

- practices and measures to avoid contamination with biological, chemical or physical hazards such as mycotoxins, heavy metals, radioactive material, etc.

- the use of water in primary production,

- the use of organic waste in primary production,

- 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:

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

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


ANNEX II

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

Introductory remarks

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.

The remaining Chapters of the Annex 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.

CHAPTER I

General requirements for food premises including outside areas and sites (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, 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.

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 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, 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.

(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 '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 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 minimise the risk of contamination.

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

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

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 [14]. This potable water must be used whenever necessary to ensure that foodstuffs are not contaminated.

[14] OJ L 330, 5.12.1998, p. 32.

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.

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.

CHAPTER XI Special conditions for certain processing operations

1. Processing by heat treatment

- 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.

- 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;

- If the heat treatment is applied before wrapping, measures must be taken to prevent recontamination of the food after heating and before filling;

- 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;

- 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.

- 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

- Fumes and heat must not affect other operations.

- Materials used for smoke production must be stored and used in such a way as to avoid contamination of foodstuffs.

- 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 contamination. 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.