S.I. No. 165/2000 - European Communities (Hygiene of Foodstuffs) Regulations, 2000

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. 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.

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.

GIVEN under my official seal this 3rd day of June, 2000

Micheál Martin

______________

Minister for Health and Children

Explanatory Note

(This note is not part of the Regulations and does not purport to be a legal interpretation).

These Regulations give effect to Council Directive 93/43/EEC on the hygiene of foodstuffs. They cover all stages after primary production and set down the obligations on proprietors of food businesses, 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 Directives 96/3/EC and 98/28/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 and the transport by sea of bulk raw sugar.

The Regulations also provide for the Food Safety Authority of Ireland to approve Guides to Good Hygiene Practice which may be used voluntarily by food businesses as a guide to compliance with these Regulations.

1

OJ No L175, 19.7.93, p.1

2

OJ No L21, 27.1.96, p.42

3

OJ No L140, 12.5.98, p.10

4

OJ No L186, 30.6.1989, p.23

5

OJ No L330, 5.12.1998, p.32

6

OJ No 121, 29.7.1964, p2012/64

(1) Insert the name and address of the person submitting the sample for analysis.

(2) Insert description (i.e. officer of Health Board etc.)

(3) Insert particulars of marking (e.g. name, date etc.)

(4) This may be left unanswered if the sample cannot be conveniently weighed or measured or the weight or measurement is not material to the result of analysis.

(5) State whether the analysis was carried out by an approved examiner or under his direction by deleting appropriate words (“by me” or “under my direction”).

(6) Here the approved examiner should specify the result of the analysis having regard to the provision of relevant legislation.

(7) Here the approved examiner may insert, at his discretion, his opinion whether the analysis indicates any addition, abstraction, deficiency or the presence of foreign matter or other defect and whether the composition or quality is thereby affected; any physical, chemical or other properties bearing on the composition or quality of the article; whether the article is injurious to health or unfit for human consumption; whether and in what respect a label and description relating to the sample is incorrect or misleading; and he may add any other observations as he may consider relevant.

(8) Insert the name and address of the laboratory carrying out the analysis/examination.

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.

PART II

SPECIFIC REQUIREMENTS IN ROOMS WHERE FOODSTUFFS ARE PREPARED, TREATED OR PROCESSED (EXCLUDING DINING AREAS AND THOSE PREMISES SPECIFIED IN PART III)

10. (1) In the enforcement of these Regulations, the Food Safety Authority of Ireland shall

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

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

(c) ensure that all food businesses are inspected at a frequency which has regard to the risk associated with the business.

(2) (a) The Food Safety Authority of Ireland 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, as amended, in order to ensure that the provisions of these Regulations are being complied with.

(b) Without prejudice to subparagraph (a), the powers contained in the Act of 1998 may be exercised for the purpose of ensuring compliance with these Regulations.

11. (1) If, in the enforcement of these Regulations, the Food Safety Authority of Ireland ascertains that failure to comply with the provisions 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 the destruction of the foodstuff or to the closure of all or part of a food business for an appropriate period of time.

(2) In determining, for the purposes of these Regulations, 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.

12. The Minister for Health and Children, after consultation with the Food Safety Authority of Ireland, may, by order, provide for interim protective measures with regard to imports of foodstuffs from all or part of a third country as provided for in Article 10 of Directive 93/43/EEC.

13. Without prejudice to Regulations 7 to 12, before entry into a service contract by a health board with the Food Safety Authority of Ireland under the Act of 1998, the powers contained in Regulations 14 to 28 may be exercised for the purpose of ensuring compliance with these Regulations and these Regulations shall be enforced and executed by health boards in their functional areas.

14. (1) The Chief Executive Officer of a health board may appoint in writing such and so many officers of the health board or a local authority as he or she thinks fit to be authorised officers for the purposes of ensuring compliance with these Regulations in the functional area of the health board.

(2) A person appointed as an authorised officer under the European Communities (Hygiene of Foodstuffs) Regulations, 1998 (

S.I. No. 86 of 1998

) and holding office as an authorised officer immediately before the making of these Regulations shall continue in office as if appointed under this Regulation.

(3) 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 under these Regulations, shall, if requested by any person affected, produce the certificate to that person.

(4) For the purposes of ensuring compliance with these Regulations after entering into a service contract between the Food Safety Authority of Ireland and a health board, the appointments referred to in paragraph (1) and (2) shall continue in force.

15. A health board, when determining compliance with the Regulations shall have due regard to-

(a) Any relevant guide to good hygiene practice approved in accordance with paragraph (1) of Regulation 5 and forwarded to the Commission pursuant to paragraph (6) of that Regulation, and

(b) any European guide to good hygiene practice developed in accordance with Article 5.6 and 5.7 of Directive 93/43/EEC and published per Article 5.8 thereof.

16. (1) In the enforcing of these Regulations, a health board shall :-

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

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

(c) ensure that all food businesses are inspected with a frequency which has regard to the risk associated with the business.

(2) A health board shall ensure that controls on foodstuffs imported into the Community are carried out in accordance with these Regulations.

17. (1) If, in the enforcement of these Regulations, a health board ascertains that failure to comply with the provisions 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 the destruction of the foodstuff or to the closure of all or part of a food business for an appropriate period of time in accordance with the provisions of these Regulations.

(2) In determining for the purposes of these Regulations 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.

18. (1) An authorised officer may for the purpose of ensuring that these Regulations are being complied with -

(a) require any employee of the health board, a former employee of the health board or any person otherwise currently or previously retained by the health board, or any person who carries or has carried on any trade, business or activity to which these Regulations relate or any person currently or previously employed in connection with that trade, business or activity to produce to him or her such records, and in the case of such information in a non-legible form to reproduce it in a permanent legible form, or to give him or her such information, as the officer may reasonably require in relation to any entries in such records,

(b) at all reasonable times enter any premises, subject to paragraph (3), at which there are reasonable grounds to believe that any trade, business or activity in connection with the production, processing, disposal, manufacture, exportation, importation, storage, distribution or sale of food, is or has been carried on, or that records in relation to such trade, business or activity are kept, and search and inspect the premises and any records in or on the premises,

(c) secure for later inspection any premises or any part thereof in which such records are kept or there are reasonable grounds for believing that such records are kept,

(d) require any person in charge thereof or so employed therein, to produce to the officer such records and to give to the officer such information as the officer may reasonably require in relation to any entries in such records,

(e) inspect and take copies of or extracts from any such records (including in the case of information in a non-legible form a copy of or extract from such information in a permanent legible form),

(f) remove and retain the said records for such period as may be reasonable for further examination or until the conclusion of any legal proceedings,

(g) as regards any foodstuff the officer finds at or in a premises, require any person in charge thereof or any person who appears to the officer to be in possession of the foodstuff, to supply without payment, for test, examination or analysis sufficient samples thereof,

(h) require any person to afford the officer such facilities and assistance within his or her control or responsibilities as are reasonably necessary to enable the officer to exercise any of the powers conferred on an authorised officer under this Regulation,

(i) require a person referred to in subparagraph (a) to give to the officer any information which the officer may reasonably require in regard to the trade, business or activity or in regard to the persons carrying on such trade, business or activity or employed in connection with that trade, business or activity,

(j) require any person referred to in subparagraph (a) by or on whose behalf data equipment is or has been used in relation to a business within the meaning of subparagraph (b) or any person having charge of, or otherwise concerned with the operation of, the data equipment or any associated apparatus or material, to afford the officer all reasonable assistance in relation to its use thereto,

(k) summon, at any reasonable time, any other person being or having been an employee of the health board or retained or having been retained by the health board or employed in connection with the trade, business or activity under examination by the health board to give to the officer any information which the officer may reasonably require in regard to that trade, business or activity and to produce to the officer any records which are in that person's power or control;

(l) examine any procedure connected with the manufacture of a foodstuff, and

(m) exercise such other powers as may be necessary to ensure that these Regulations are being complied with.

(2) Where an authorised officer has reasonable grounds for believing that a person has contravened any provision of these regulations and so informs such person, the authorised officer may require such person to state his name and address and, if the authorised officer thinks it necessary, to produce corroborative evidence of his name and address.

(3) An authorised officer shall not, other than with the consent of the occupier, enter a private dwelling unless he or she has obtained a warrant from the District Court under paragraph (6) authorising such entry.

(4)

Where an authorised officer in the exercise of the officer's powers under this Regulation is prevented from entering any premises an application may be made to the District Court under paragraph (6) for a warrant authorising such entry.

(5) An authorised officer may require a member of the Gárda Síochána to assist him in the exercise of any power conferred on him by these Regulations which involves the detention of any person, the bringing of any person to any place, the breaking open of any premises or any other action in which the use of force may be necessary and is lawful, and any member of the Gárda Síochána so required shall comply with the requirement. An authorised officer where he considers is necessary, may be accompanied by a member of the Garda Síochána when performing any powers conferred on an authorised officer under this Regulation.

(6) If a judge of the District Court is satisfied on the sworn information of an authorised officer that there are reasonable grounds for suspecting that there is information required by an authorised officer under this Regulation held on or in any premises, or any part of any premises or there is a product which an authorised officer requires to inspect for purposes of these Regulations or that such inspection is likely to disclose evidence of a contravention of these Regulations, the judge may issue a warrant authorising an authorised officer, accompanied, if appropriate, by other authorised officers or by a member of the Garda Síochána, at any time or times within one month from the date of issue of the warrant, on production, if so requested, of the warrant, to enter, if need be by reasonable force, the premises and exercise all or any of the powers conferred on an authorised officer under this Regulation.

(7) An application under paragraph (6) shall be made to the judge of the District Court in whose district court district the premises is situated.

(8) A person who has gained access to information by virtue of inspections made in the enforcement of these Regulations shall not disclose such information unless it is necessary to do so for the purpose of the enforcement of these Regulations. Any person who contravenes this paragraph shall be guilty of an offence.

19. Control for the purposes of these Regulations shall comprise one or more of the following operations in accordance with the conditions laid down in these Regulations, and in the light of the examinations to be carried out

(a) inspection;

(b) sampling and analysis;

(c) inspection of staff hygiene;

(d) examination of written and documentary material;

(e) examination of any verification systems set up by the undertaking and of the results obtained.

20. (1) The following may be subject to inspection by an authorised officer in the enforcement and execution of these Regulations

(a) the state and use which is made at the different stages enumerated in Regulation 9(3) of the European Communities (Official Control of Foodstuffs) Regulations, 1998 (

S.I. No. 85 of 1998

), as amended, of the site, premises, offices, plant and plant surroundings, means of transport, machinery and equipment;

(b) raw materials, ingredients, technological aids and other products used for the preparation and production of foodstuffs;

(c) semi-finished products;

(d) finished products;

(e) materials and articles intended to come into contact with foodstuffs;

(f) cleaning and maintenance products and processes and pesticides;

(g) processes used for the manufacture or processing of foodstuffs;

(h) labelling and presentation of foodstuffs;

(i) preserving methods.

(2) The operations enumerated in paragraph (1) of this Regulation may where necessary be supplemented by

(a) interviews with the head of the inspected undertaking and with persons working for that undertaking;

(b) the reading of values recorded by measuring instruments installed by the undertaking;

(c) inspections carried out by the health board, with its own instruments, of measurements taken with the instruments installed by the undertaking.

21. (1) Inspections shall be carried out

(a) regularly and/or

(b) where non-compliance is suspected.

(2) Inspections shall be carried out using means proportionate to the end to be observed.

(3) Inspection shall cover all stages of production, manufacture, import, processing, storage, transport, distribution and trade.

(4) As a general rule, inspections shall be carried out without prior warning.

(5) The health board shall, in each case, select the stage or stages which it considers the most appropriate for its examination from those listed in paragraph (3) of this Regulation.

22. (1) Persons who, in the exercise of their activity come into contact, whether directly or indirectly, with the materials and products referred to in Regulation 20(1)(b) to (f) shall be subject to the hygiene inspection referred to in Regulation 19(c).

(2) The inspection referred to in paragraph (1) shall be carried out for the purpose of checking that the health standards concerning personal cleanliness and clothing are respected. Performance of this inspection shall be without prejudice to medical examinations.

23. (1) An authorised officer may, for the purposes of these Regulations purchase or take without payment a sample of any controlled item.

(2) An authorised officer may for the purpose of taking a sample of a controlled item open any receptacle.

(3) Where an authorised officer purchases or takes without payment, with the intention of having it analysed by an approved examiner, a sample of a controlled item which is suspected by him -

(a) to be diseased, contaminated or otherwise unfit for human consumption, and/or

(b) to fail to comply with the provisions of any other Regulations applicable to such a controlled item,

he may, by notice in writing to the seller, owner or person in apparent charge or control of such item (as the case may be) prohibit the removal of the controlled item except to any place which may be specified in the notice, during such period as may be specified in the notice, but not exceeding fourteen days from the date of the taking of the sample.

(4) Where an authorised officer purchases or takes without payment a sample of a controlled item with the intention of having it analysed by an approved examiner within the meaning of the European Communities (Official Control of Foodstuffs) Regulations, 1998, as amended, in an official laboratory approved under the European Communities (Official Control of Foodstuffs) (Approved Laboratories) Order, 1998 (

S.I. No. 95 of 1998

), he shall after purchasing or taking the sample forthwith notify the seller, owner or person in apparent charge or control of the controlled item (as the case may be) of his intention of having the sample analysed.

(5) Nothing in this Regulation shall authorise the examination or detention of a controlled item without the consent of an officer of the Revenue Commissioners where the duties of such officer in relation to such item have not been wholly discharged.

24. (1) Where a sample of any product, article or substance is supplied pursuant to paragraph (1)(g) of Regulation 18 and where the division of the sample is reasonably practicable, the authorised officer concerned may divide the sample into not more than three approximately equal parts each of which he shall mark in such a way as to identify it as a part of the sample taken by the officer. The authorised officer shall mark, seal and fasten each part in such a manner as its nature will permit, forward one part to a laboratory approved under the European Communities (Official Control of Foodstuffs) (Approved Laboratories) Order, 1998 (

S.I. No. 95 of 1998

), where it may be tested, examined or analysed for the purposes of these Regulations by an approved examiner, within the meaning of the European Communities (Official Control of Foodstuffs) Regulations, 1998, as amended, give or send one part to the seller, owner or person in apparent charge or control of the product, article or substance and retain the third part.

(2) Where an authorised officer takes a sample consisting of a product, article or substance contained in unopened containers and its division into parts—

(a) is not reasonably practicable, or

(b) might affect the composition or impede the proper analysis of the sample,

the provision of paragraph (1) as regards the division of samples into parts shall be deemed to be complied with if the authorised officer divides the containers into three lots and deals with each lot as if it were a sample as specified under paragraph (1).

(3) In proceedings for an offence under these Regulations, the result of any test, examination or analysis of, or report on a sample of a controlled item taken pursuant to these Regulations shall not be adduced unless before the proceedings were instituted the sample was divided as specified in paragraphs (1) and (2) of this Regulation. The part, package or container retained by the authorised officer shall be produced at the hearing.

25. (1) The approved examiner within the meaning of Regulation 23(4) or a person under his direction shall analyse as soon as possible any sample of a product, article of substance submitted to him in pursuance of these Regulations and the approved examiner shall certify to the person who submitted the sample to him the result of such analysis. If the sample is found to be diseased, contaminated or otherwise unfit for human consumption, the form of certificate set out in the First Schedule to these Regulations or a certificate in like form shall be used.

(2) An official certificate given in accordance with paragraph (1) may be adduced in evidence in a prosecution under these Regulations and shall be

prima facie

evidence of the matters contained therein, until the contrary is proved.

26. Where a sample of a product, article or substance is taken by an authorised officer in pursuance of these Regulations for analysis by an approved examiner, and where the seller, owner or person in apparent charge or control of such item requests in writing the results of such analysis, the request shall be made to the health board in whose area the sample was taken and the health board shall comply with such request.

27. (1) Whenever a Chief Executive Officer of a health board has evidence that there is a grave and immediate danger that a foodstuff or foodstuffs intended for sale for human consumption may become so diseased, contaminated or otherwise unfit for human consumption as to be liable to cause serious illness if consumed, he may apply to the Justice of the District Court for a Closure Order prohibiting the operation of the food business and on such application such Justice may, as he thinks fit, grant, or refuse to grant, such an Order.

(2) A Chief Executive Officer of a health board shall cause written notice of his intention to seek a Closure Order against a food business to be given to the proprietor of the said business before the date of the court hearing.

(3) A proprietor of a food business in respect of which a Closure Order is enforced may, at any time, apply to the Justice of the District Court for an annulment of the Closure Order and such District Justice may, as he thinks fit, confirm or annual the Closure Order.

(4) No person shall carry on a food business in respect of which an Order under this Regulation is for the time being in force.

28. (1) An authorised officer may seize, remove, detain and/or direct the withdrawal from the market of any controlled item intended for sale for human consumption which is -

(a) suspected by him to be diseased, contaminated or otherwise unfit for human consumption, and/or

(b) suspected by him to fail to comply with the provisions of any other Regulations applicable to such a controlled item.

(2) With the consent in writing of the owner or person in apparent charge or control of such controlled item, or in accordance with an order of a Justice of the District Court under paragraph (4) of this Regulation destroy or otherwise dispose of same as to prevent it being used for human consumption.

(3) An authorised officer who has seized a controlled item in pursuance of the provisions of this Regulation may, on giving notice in writing to the owner or person responsible for such item of his intention to do so, apply to a Judge of the District Court for an order directing that such item be destroyed or otherwise disposed of.

(4) A Judge of the District Court to whom the application is made for an order under paragraph (3) may, if satisfied that such item -

(a) is diseased, contaminated or otherwise unfit for human consumption, and/or

(b) fails to comply with the provisions of any other Regulations applicable to such a controlled item,

order that it be destroyed or otherwise disposed of after such period, not exceeding fourteen days, as may be specified in such order, and an authorised officer shall destroy or dispose of it accordingly.

29. (1) A person who fails to comply with these Regulations shall be guilty of an offence.

(2) A person who falsely represents himself to be an authorised officer shall be guilty of an offence.

(3) A person who -

(a) obstructs or interferes with an authorised officer in the exercise of the officer's powers under these Regulations, or

(b) fails or refuses to state his name or address in compliance with a requirement under these Regulations, or

(d) fails to comply with a request from an authorised officer under these Regulations, or

(e) makes a statement to an authorised officer which the person knows is false or misleading,

(f) gives in purported compliance with a requirement under these Regulations a name, an address or corroborative evidence which is false or misleading

shall be guilty of an offence.

(4) A person who is guilty of an offence under these Regulations shall be liable on summary conviction to a fine not exceeding £1,500 or at the discretion of the Court to imprisonment for a term not exceeding six months, or both.

(5) For the purposes of these Regulations, every contravention of a Regulation shall be deemed to be a separate contravention and every contravention of a paragraph shall be deemed to be a separate contravention and shall carry the same penalty as for a single contravention of any Regulation of these Regulations.

30. Where an offence under these Regulations is committed by a body corporate or by a person acting on behalf of a body corporate and is proved to have been so committed with the consent, connivance or approval of, or to be attributable to any neglect on the part of any director, manager, secretary or any other officer of such body or a person who was purporting to act in any such capacity, such person shall also be guilty of an offence and shall be liable to be proceeded against and punished as if he were guilty of the first-mentioned offence.

31. An offence under these Regulations may be prosecuted by the health board in whose functional area the offence was committed.

32. (1) The European Communities (Hygiene of Foodstuffs) Regulations, 1998 (

S.I. No. 86 of 1998

) are hereby revoked.

(2) References in any other instrument to the Regulations revoked under paragraph (1) shall be construed as references to these Regulations, as appropriate.

First Schedule

Form of official certificate to be given by an approved examiner to an authorised officer.

European Communities (Hygiene of Foodstuffs) Regulations, 2000

Certificate of Analysis

To (1)

..............................

I, the undersigned (2)

........................................

being the Approved Examiner for the purpose of Regulations 23 to 26 of the above Regulations certify that on

the ............................day of ...................20 ....

a sample marked (3)

..............................

Date .................................

Number .....................................

Weight or Measure (4)

........................

was submitted to me by you and I certify that the sample has been analysed/examined by me or under my direction (5)

and as a result I am of the opinion that (6)

Observations : (7)

I further certify that the sample has undergone no change which would affect my opinion/observations expressed above.

Certified by me this ..................... day of ..................... 20 ....

at (8)

...........................

Name in BLOCK LETTERS ....................... Status .....................

Signature ........................

_____________

Official Stamp

NOTES

Second Schedule

PREFACE

I, Micheál Martin, 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), for the purpose of giving effect to Council Directive 93/43/EEC

1

of 14 June 1993 on the hygiene of foodstuffs, Commission Directive 96/3/EC

2

of 26 January 1996 granting a derogation from certain provisions of Council Directive 93/43/EEC on the hygiene of foodstuffs as regards the transport of bulk liquid oils and fats by sea, and Commission Directive 98/28/EC

3

of 29 April 1998 granting a derogation from certain provisions of Directive 93/43/EEC on the hygiene of foodstuffs as regards the transport by sea of bulk raw sugar, hereby make the following Regulations