S.I. No. 86/1998:

EUROPEAN COMMUNITIES (HYGIENE OF FOODSTUFFS) REGULATIONS, 1998

EUROPEAN COMMUNITIES (HYGIENE OF FOODSTUFFS) REGULATIONS, 1998

I, BRIAN COWEN, Minister for Health and Children, in exercise of the powers conferred on me by Section 3 of the European Communities Act, 1972 (No. 27 of 1972) hereby make the following Regulations for the purposes of giving effect to Council Directive 9¾3/EEC⁽¹⁾ on the subject of the hygiene of foodstuffs and Commission Directive 96/3/EC⁽²⁾ on the subject of the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea.

⁽¹⁾OJ No. L 175, 19.7.1993 p.1

⁽²⁾OJ No. L21 27.1.96 p.42

PART 1

1. These Regulations may be cited as the European Communities (Hygiene of Foodstuffs) Regulations, 1998.

2. These Regulations shall come into operation on the first day of April 1998.

3. (1) In these Regulations "Authorised Officer" means

(a) an officer of the Minister who is authorised in writing by the Minister to be an authorised officer for the purposes of these Regulations; or

(b) an officer of a health board or of a local authority who is authorised in writing by the Chief Executive Officer of the health board to be an authorised officer for the purposes of these Regulations;

(2) An authorised officer shall be furnished with a certificate of his appointment as an authorised officer and when exercising any power conferred on an authorised officer by these Regulations shall, if so requested by a person affected, produce the certificate for the inspection of the person.

4. In these Regulations--

"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" means all measures necessary to ensure the safety and wholesomeness of foodstuffs. The measures shall cover all stages after primary production (including, for example, harvesting, slaughtering and milking) during preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply to the consumer;

"health board" means a health board established under Section 4 (1) of the Health Act, 1970 (No. 1 of 1970);

"the Minister" means the Minister for Health and Children;

"potable water" means water which complies with the standards of the Council of European Communities and, in particular, European Communities (Quality of Water intended for Human Consumption) Regulations, 1988 ( S.I. No. 207 of 1988 ),

"proprietor" in relation to a food premises, means the person who carries on the food business at that premises and includes the person, for the time being, in charge;

"sale" and "sell" include offering or keeping for sale or for any other manner of disposal in the community;

"where appropriate" and "where necessary" means for the purposes of ensuring the safety and wholesomeness of foodstuffs.

"wholesome food" means food which is fit for human consumption as far as hygiene is concerned.

5. These Regulations shall be enforced and executed by health boards in their functional areas.

6. (1) Any person who contravenes any article or sub-article of these Regulations shall be guilty of an offence and shall, unless otherwise provided for in the specific regulations, be liable on summary conviction to a fine not exceeding £1,000 or at the discretion of the Court, to imprisonment for a term not exceeding 6 months or to both.

(2) For the purposes of these Regulations, every contravention of an Article shall be deemed a separate contravention and every contravention of a sub-article shall also be deemed to be a separate contravention and shall carry the same penalty as for a single contravention of any Article of these Regulations.

(3) Where an offence under these Regulations is committed by a body corporate and the offence is proved to have been committed with the consent or connivance of, or to be attributed to any neglect on the part of any director, secretary or other similar officer of the body, or other person who was purporting to act in any such capacity, he, as well as the body, shall be guilty of the offence.

(4) Notwithstanding Section 10(4) of the Petty Sessions (Ireland) Act, 1851, proceedings for an offence under these Regulations may be instituted within twelve months from the date of the offence or any time within twelve months from the date on which knowledge of the commission of the offence came to the attention of an authorised officer.

7. An offence under these Regulations may be prosecuted by--

(a) the Minister, or

(b) a health board within whose functional area the offence was committed.

8. A word or expression that is used in these Regulations and is also used in Council Directive 9¾3/EEC or Commission Directive 96/3/EC has, unless the contrary intention appears, the meaning in these Regulations that it has in the Council Directive or Commission Directive.

9. (1) A Health Board shall carry out controls in accordance with the European Communities (Official Control of Foodstuffs) Regulations, 1998 ( S.I. No. 85 of 1998 ) in order to ensure that the provisions of these Regulations and where appropriate the provisions of any order made in accordance with Article 12 of these Regulations are being complied by food businesses.

(2) A Health Board shall ensure that controls on foodstuffs imported into the Community are carried out in accordance with the European Communities (Official Control of Foodstuffs) Regulations, 1998 ( S.I. No. 85 of 1998 ) in order to ensure that the provisions of these Regulations and where appropriate the provisions of any order made in accordance with Article 12 of these Regulations are being observed.

(3) In enforcing and executing these Regulations, a health board shall--

(a) ensure that

(i) food premises are inspected with a frequency which has regard to the risk associated with those premises, and

(ii) inspections include a general assessment of the potential food safety hazards associated with the business;

(b) pay particular attention to the critical control points identified by food businesses to assess whether the necessary controls are being monitored and verification controls are being operated.

(4) In determining for the purposes of these Regulations whether any matter involves a 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.

(5) If while carrying out controls referred to in this article, a health board ascertains that failure to comply with the provisions of these Regulations or where appropriate the provisions of any order made in accordance with Article 12 of these Regulations, might result in risks to the safety or wholesomeness of foodstuffs, it shall take appropriate measures, which may extend to the withdrawal and/or closure of all or part of a food business for an appropriate period of time in accordance with the provisions of the European Communities (Official Control of Foodstuffs) Regulations, 1998 ( S.I. No. 85 of 1998 )

10. (1) The Minister may aprove guides to good hygiene practice which may be used by food businesses as a guide to compliance with the provisions of these Regulations.

(2) The Minister may withdraw any approval to any guide to good hygiene practice referred to in sub-article (1) of this Article.

(3) Where guides to good hygiene practice referred to in sub-article (1) are developed, they shall be developed as follows--

(i) by food business sectors or by organisations representative of food business sectors or other interested parties,

(ii) in consultation with the interests substantially affected including the health boards, and

(iii) where appropriate, having regard to the Recommended International Code of Practice, General Principles of Food Hygiene of the Codex Alimentarius.

(4) Guides to good hygiene practice may be developed under the aegis of a national standards institute, which for the time being, shall be the National Standards Authority of Ireland.

(5) The Minister shall, if he considers it appropriate, recommend that the proprietor of a food business apply the European Standards of the EN 29000 series in order to comply with the requirements of these Regulations and/or any approved guide to good hygiene practice.

11. A Health Board when determining compliance with these Regulations shall have due regard to any relevant guide to good hygiene practice which has been--

(a) approved by the Minister in accordance with Article 10 of these Regulations and forwarded to the Commission pursuant to Article 5.5 of Council Directive 9¾3/EEC, or

(b) developed in accordance with Article 5.6 and 5.7 and published in accordance with Article 5.8 of the Council Directive 9¾3/EEC.

12. (1) The Minister may by order prescribe temperature control or microbiological control criteria for certain classes of foodstuffs.

(2) The proprietor of a food business shall comply with any order made by the Minister under sub-article (1) of this Article.

PART II

13. (1) These Regulations shall not apply to a food premises or that part of a food premises in which no food business is carried on other than that which is subject to:--

(a) Dairy Produce Act, 1924 , (No. 58 of 1924), or

(b) the European Communities (Hygienic Production and Placing on the Market of Raw Milk, Heat-Treated Milk and Milk-Based Products) Regulations, 1996 ( S.I. No. 9 of 1996 ), or

(c) European Communities (Wild Game) Regulations 1995 ( S.I. No. 298 of 1995 ), or

(d) European Communities (Rabbit Meat and Farm Game Meat) Regulations 1995, ( S.I. No. 278 of 1995 ), or

(e) European Communities (Meat Products and Other Products of Animal Origin) Regulations, 1995 ( S.I. No. 126 of 1995 ), or

(g) European Communities (Fresh Poultymeat) Regulations, 1996 ( S.I. No. 3 of 1996 )

(h) The Fresh Meat Acts (1930 -- 1988), or

(i) The Abattoirs Act 1988 (No. 8 of 1988), or

(j) Directive 64/433/EEC⁽¹⁾ on health conditions for the production and marketing of fresh meat, as amended, or

⁽¹⁾OJ No. 121, 29/7/1964, p2012/64)

(k) European Communities (Minced Meat and Meat Preparations) Regulations, 1996 ( S.I. No. 243 of 1996 ), or

(l) European Communities (Live Bivalve Molluscs) (Health Conditions for Production and Placing on the Market) Regulations, 1996. ( S.I. No. 147 of 1996 ), or,

(m) European Communities (Fishery Products) (Health Conditions and Hygiene Rules for Production and Placing on the Market) Regulations, 1996 ( S.I. No. 170 of 1996 )

(2) These Regulations shall not apply to a food business in which two or more different classes of food business as described in sub-article (1) are carried on, and to which these Regulations would not apply if each class of business were carried on separately in the same premises or part thereof.

14. Notwithstanding more specific requirements set out in this Part of 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 foodstuffs shall be carried out in a hygienic way.

15. The proprietor of a food business shall ensure that any step 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 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-hereinafter known as the critical points,

(iv) identifying and implementing effective control and monitoring procedures at those critical points, and

(v) reviewing the analysis of food hazards, the critical control points and the control and monitoring procedures periodically and whenever the food business operations change.

16. The following provisions shall be complied with in relation to a food premises and a food business carried on in connection therewith by the proprietor thereof--

(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) (a) an adequate number of washbasins must be available, suitably located and designated for cleaning hands.

(b) an adequate number of flush lavatories must be available and connected to an effective drainage system.

(c) 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) (a) There must be suitable and sufficient means of natural or mechanical ventilation.

(b) 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 and must be designed and constructed to avoid the risk of contamination of foodstuffs.

(9) Adequate changing facilities for personnel must be provided where necessary.

17. (1) The proprietor of a food premises in which a food business is carried on shall ensure that the following provisions are complied with in relation to rooms (excluding dining areas) where food is prepared, treated or processed:--

(a) (i) 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 health board that other materials used are appropriate;

(ii) 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 nontoxic materials and require a smooth surface up to a height appropriate for the operations unless food business operators can satisfy the health board 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) (i) 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.

(ii) 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 health board 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 health 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) (a) When appropriate, adequate provision must be made for any necessary washing of the food.

(b) 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.

18. The provisions of Article 17 shall not apply to a food business to which the provisions of Article 19 apply.

19. The proprietor of a food business which is carried on from a 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 or from a vending machines on shall ensure that the following provisions are complied with

(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 health board 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.

20. The proprietor of a food business shall ensure that the following provisions are complied with:--

(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.

(3) Subject to the provisions of Article 28 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".

(4) 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.

(5). 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.

(6) Foodstuffs in conveyances and/or containers must be so placed and protected as to minimise the risk of contamination.

(7) 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.

21. The proprietor of a food business shall ensure that in relation to all articles, fittings and equipment with which food comes into contact, the following provisions shall be complied with:--

(a) shall be kept clean, and 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, where necessary, disinfected, sufficient for the purposes intended;

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

22. The proprietor of a food business shall ensure that the following provisions are complied with:--

(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 health board 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.

23. The proprietor of a food business shall ensure that the following provisions are complied with:--

(1) There must be an adequate supply of potable water. This potable water must be used whenever necessary to ensure foodstuffs are not contaminated.

(2) When appropriate, ice must be made from potable water. 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.

24. 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.

25. The proprietor of a food business shall ensure that 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.

26. The proprietor of a food premises in which a food business is carried on shall ensure that the following provisions are complied with in respect of food used for the business:--

(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 minimise any risk of contamination.

(4) Adequate procedures must be in place to ensure pests are controlled.

(5) 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.

(6) 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.

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

27. The proprietor of a food business shall ensure that food handlers are supervised and instructed and/or trained in food hygiene matters commensurate with their work activity.

28. (1) (a) The bulk transport in sea-going vessels of liquid oils and fats which are to be processed, and are intended for, or likely to be used for human consumption, is permitted in tanks that are not exclusively reserved for the transport of food subject to the following conditions--

(i) where the oil or fat is transported in a stainless steel tank, or tank lined with epoxy resin or technical equivalent, the immediate previous cargo transported in the tank shall have been food or a cargo from the list of acceptable previous cargoes set out in the Schedule to these Regulations,

(ii) where the oil or fat is transported in a tank of materials other than those specified in sub-paragraph (i), the three previous cargoes transported in the tanks shall have been food, or from the list of previous acceptable cargoes as set out in the Schedule to these Regulations.

(b) The bulk transport in sea-going vessels of liquid oils and fats which are not to be processed and are intended for, or likely to be used for human consumption, is permitted in tanks that are not exclusively reserved for the transport of food subject to the following conditions--

(i) the tank shall be of stainless steel or lined with epoxy resin or technical equivalent,

(ii) the three previous cargoes transported in the tank shall have been food.

(3) The captain of the sea-going vessel transporting in tanks, bulk liquid oils and fats intended for or likely to be used for human consumption shall keep accurate documented evidence relating to the three previous cargoes carried in the tanks concerned and the effectiveness of the cleaning process applied between these cargoes.

(4) Where the cargo has been trans-shipped, in addition to the documented evidence required in sub-article (3), the captain of the receiving vessel shall keep accurate documented evidence that the transport of the bulk liquid oil or fat complied with the provisions in sub-articles (1) and (2) during previous shipment and of the effectiveness of the cleaning process applied between these cargoes on the other vessel.

(5) Upon the request of an authorised officer the captain of a vessel to which this Article relates shall provide the authorised officer with the documented evidence described in sub-articles (3) and (4).

SCHEDULE

List of acceptable previous cargoes

GIVEN under the Official Seal of the Minister for Health and Children, this 31st day of March, 1998.

BRIAN COWEN,

Minister for Health and Children.

EXPLANATORY NOTE.

These Regulations give effect to Council Directive 9¾3/EEC on the hygiene of foodstuffs. They set down the obligations on proprietors of food business, including the requirement that such business is operated in a hygienic way. The rules of hygiene cover requirements for premises, rooms where food is prepared, foodstuffs, transportation, equipment, food waste, water supply, personal hygiene and training. Proprietors are also obliged to identify steps in the activities of the business which are critical to ensuring food safety and ensure that adequate safety procedures are identified, implemented and reviewed.

The Regulations also give effect to Commission Directive 96/3/EC which provides a derogation from part of the Annex to Directive 94/43/EEC and lays down equivalent conditions to ensure the protection of the public health and safety of food in the case of the bulk transport in sea going vessels of liquid oils or fats.

The Regulations also provide for the Minister for Health to approve Guides to Good Hygiene Practice which may be used voluntarily by food businesses as a guide to compliance with these Regulations.