S.I. No. 126/1995:

EUROPEAN COMMUNITIES (MEAT PRODUCTS AND OTHER PRODUCTS OF ANIMAL ORIGIN) REGULATIONS, 1995.

EUROPEAN COMMUNITIES (MEAT PRODUCTS AND OTHER PRODUCTS OF ANIMAL ORIGIN) REGULATIONS, 1995.

I, IVAN YATES, Minister for Agriculture, Food and Forestry, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972) and for the purpose of giving effect to Council Directive No. 77/99/EEC⁽¹⁾ of 21 December 1976 as updated and amended by Council Directive No. 92/5/EEC ⁽²⁾ of 10 February 1992 and subsequently amended by Council Directive No. 92/45/ EEC⁽³⁾ of 16 June 1992, Council Directive No. 92/116/EEC⁽⁴⁾ of 17 December 1992, Council Directive No. 92/118/EEC⁽⁵⁾ of 17 December 1992, Council Directive No. 92/120/EEC⁽⁶⁾ of 17 December 1992 and Commission Decision No. 94/383/EC⁽⁷⁾ of 3 June 1994, hereby make the following Regulations:

PART I PRELIMINARY

1. (1) These Regulations may be cited as the European Communities (Meat Products and other Products of Animal Origin) Regulations, 1995.

(2) These Regulations shall come into operation on the twenty fourth day of May, 1995.

2. (1) In these Regulations, except where the context otherwise requires--

"authorised officer" means a person authorised in writing by the Minister to exercise for the purposes of these Regulations and the Council Directive the powers conferred on an authorised officer by these Regulations;

⁽¹⁾ O.J. No. L26 of 31.1.1977, P.85.

⁽²⁾ O.J. No. L57 of 2.3.1992, P.1.

⁽³⁾ O.J. No. L268 of 14.9.1992, P.35.

⁽⁴⁾ O.J. No. L62 of 15.3.1993, P.1.

⁽⁵⁾ O.J. No. L62 of 15.3.1993, P.49.

⁽⁶⁾ O.J. No. L62 of 15.3.1993, P.86.

⁽⁷⁾ O.J. No. L174 of 8.7.1994, P.33.

"certificate" means a veterinary certificate or any other document issued by a veterinary examiner and has the meaning and form assigned to it in the Council Directive;

"commercial document" has the meaning assigned to it in the Council Directive;

"consumer" means a person who buys meat products or other products of animal origin--

( a ) for his own consumption;

( b ) for consumption on premises either in his ownership or under his personal supervision or in the ownership or under the personal supervision of a person employed by him; or

( c ) for cooking on premises either in his ownership or under his personal supervision or in the ownership or under the personal supervision of a person employed by him for sale as take-away food for consumption off those premises;

"the Council Directive" means Council Directive No. 77/99/EEC of 21 December 1976 as updated and amended by Council Directive No. 92/5/EEC of 10 February 1992 and subsequently amended by Council Directive No. 92/45/EEC of 16 June 1992, Council Directive No. 92/116/EEC of 17 December 1992, Council Directive No. 92/118/EEC of 17 December 1992, Council Directive No. 92/120/EEC of 17 December 1992 and Commission Decision No. 94/383/EC of 3 June 1994;

"an establishment manufacturing meat products without an industrial structure or production capacity" means an establishment producing a quantity of less that 7.5 tonnes of finished meat product per week or one tonne per week in the case of foie gras production;

"Member State" means a Member State of the European Communities;

"the Minister" means the Minister for Agriculture, Food and Forestry;

"other products of animal origin" has the meaning assigned to it in the Council Directive;

"premises" includes any land and any buildings, structures or private dwellings;

"products which contain a small percentage of meat" has the meaning assigned to it by Article 2 of Commission Directive No. 83/201/EEC⁽⁸⁾ of 12 April 1983;

"third country" means a country which is not a member of the European Communities;

"veterinary examiner" means a veterinary inspector who is an officer of the Minister.

(2) In these Regulations--

( a ) a reference to a Regulation is to a Regulation of these Regulations, unless it is indicated that reference to some other provision is intended;

( b ) a reference to a Schedule is to a Schedule to these Regulations;

( c ) a reference to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it is indicated that reference to some other provision is intended.

(3) A word or expression that is used in these Regulations and is also used in the Council Directive has, unless the contrary intention appears, the same meaning in these Regulations as it has in the Council Directive.

3. (1) Subject to the provisions of paragraph (3), a person shall not produce or cause to be produced, rewrap, reassemble, store or place on the market meat products and other products of animal origin which are intended for human consumption or for the preparation of other foodstuffs other than in compliance with these Regulations.

(2) Subject to the provisions of paragraph (3), a person shall not use any establishment or rewrapping centre for the production, rewrapping, reassembly or storage of meat products and other products of animal origin which are intended for human consumption or the preparation of other foodstuffs, or to place these products on the market unless that establishment or rewrapping centre has been approved by the Minister in accordance with these Regulations or such products are stored in a cold store approved by the Minister under the terms of Council Directive 64/433/EEC⁽⁹⁾.

⁽⁸⁾ O.J. No. L112 of 28.4.1983, P.28.

(3) The requirements of these Regulations shall not apply to the preparation and storage, in retail shops or in premises adjacent to sales points, of meat products and other products of animal origin intended for human consumption, where the preparation and storage are performed solely for the purpose of supplying the consumer directly.

PART II APPROVAL OF MEAT PRODUCTS ESTABLISHMENTS

4. (1) Subject to the provisions of Regulation 6, the Minister may, on application, approve an establishment for the preparation and storage of meat products (including prepared meat meals) in respect of which he is satisfied that such establishment--

( a ) meets the general structural and hygienic conditions as laid down in the First Schedule;

( b ) meets the special conditions for approval and hygiene laid down in Chapters I and II of the Second Schedule;

( c ) in the case of establishments preparing and storing meat products which contain a small percentage of meat, they must comply with the requirements set out in Commission Directive No. 83/201/EEC.

(2) Where approval is sought under these Regulations for an establishment which forms an integral part of an establishment already approved by the Minister under Council Directives 64/433/EEC, 71/118/EEC⁽¹⁰⁾, 9¼95/EEC⁽¹¹⁾ of 27 November 1990 or the European Communities (Minced Meat) Regulations, 1994 ( S.I. No. 215 of 1994 ), the Minister may allow the premises, equipment and installations for staff

⁽⁹⁾ Updated by Council Directive No. 9¼97/EEC -- O.J. No. L268 of 24.9.1991, P.69.

⁽¹⁰⁾ Updated by Council Directive No. 92/116/EEC -- O.J. No. L62 of 15.3.1993, P.1.

⁽¹¹⁾ O.J. No. L268 of 24.9.1991, P.41.

and certain specified parts of the premises, where he is satisfied that there is no risk of contamination of raw materials or unwrapped products, to be common to both establishments.

(3) An approval granted under this Regulations shall relate to the owner of the establishment who originally applied for the approval. This approval shall cease in the event of the establishment being sold, ceasing trading or operation, or in the event of the death of the owner or the owner being adjudged bankrupt. Approval will also cease where an incorporated body is for any reason dissolved.

5. (1) No person shall use a premises as a rewrapping centre for meat products and other products of animal origin unless it has been approved by the Minister.

(2) The Minister may lay down the conditions for approval of rewrapping centres.

(3) The Minister may, on application, approve a premises as a rewrapping centre for meat products and other products of animal origin provided he is satisfied that such premises meets the approval conditions.

(4) An approval granted under this Regulation shall relate to the owner of the rewrapping centre who originally applied for the approval. This approval shall cease in the event of the rewrapping centre being sold, ceasing trading or operation, or in the event of the death of the owner or the owner being adjudged bankrupt. Approval will also cease where an incorporated body is for any reason dissolved.

6. (1) The Minister may, on application, and subject to compliance with the other requirements of these Regulations, grant derogations from certain of the requirements of paragraph (1) of Regulation 4 in the case of an establishment without an industrial structure or production capacity manufacturing meat products. The establishment may, subject to the production limits laid down by the Minister in paragraph (4), be granted derogations--

(i) from the requirements of paragraph 2 (g) (as regards taps) and paragraph 11 (lockers may be substituted for changing rooms) in Chapter I of the First Schedule and Chapter I of the Second Schedule; and

(ii) from paragraph 3 of Chapter I of the First Schedule, as regards rooms where the raw materials and finished products are stored. However, in this case, the establishment must have at least--

(I) a room or a secure place, where appropriate refrigerated, for the storage of raw materials, if such storage takes place;

(II) a room or a secure place, where appropriate refrigerated, for the storage of finished products, if such storage takes place.

(2) Establishments referred to in--

(i) Article 4 (1) of Council Directive No. 64/433/EEC, where the requirements laid down in the second subparagraph of Article 13 (1) to that Directive are met,

(ii) Article 4 (2) and the second subparagraph of Article 13 (1) of Council Directive 64/433/EEC,

which are engaged in the production of meat products may, on application to the Minister, be extended the derogation provided for in paragraph (1) on the understanding that the treatment of meat products in such establishments satisfies the other requirements of these Regulations.

(3) The provisions of Chapter VII of the Second Schedule shall not apply to storage operations in the establishments referred to in paragraph (1), nor to the transportation of products other than those requirements referred to in Regulation 12 (2).

(4) For the purpose of granting the derogations referred to in paragraphs (1) and (2), the Minister may fix a maximum production limit for each establishment in accordance with Commission Decision No. 94/383/EC of 3 June 1994. The granting of the derogations referred to in paragraphs (1) and (2) is subject to the observance by each establishment of the production limit laid down by the Minister.

(5) The Minister may, on application, in accordance with Commission Decision No. 94/383/EC increase the maximum production limit for an establishment.

(6) The Minister may, if he is satisfied that the production limits set under paragraphs (4) or (5) are too high in respect of any establishment without an industrial structure or production capacity, reduce the production limit for such an establishment.

(7) The Minister may, if he is satisfied that the production limits fixed under paragraph (4) have not been observed, withdraw the derogations set out in paragraphs (1) and (2).

PART III CONDITIONS FOR THE PRODUCTION AND MARKETING OF MEAT PRODUCTS

7. (1) Meat products intended to be placed on the market for human consumption must be produced in accordance with the provisions of this Part of the Regulations.

(2) The Minister may approve meat products and may set conditions for such approval.

(3) Each meat product intended to be placed on the market by an establishment must be approved by the Minister prior to such placing on the market.

(4) Meat products intended to be placed on the market for human consumption must be prepared in an establishment approved by the Minister in accordance with Regulation 4.

(5) Meat products to be placed on the market must be prepared from meat as defined in the Fourth Schedule, on the understanding that meat imported from a third country must have been inspected in accordance with the terms of Council Directive No. 90/675/EEC⁽¹²⁾ of 10 December 1990 and poultrymeat must meet the minimum requirements of Chapter III of Council Directive No. 71/118/EEC⁽¹³⁾.

(6) Meat products may not be prepared from meat declared unfit for human consumption under European Community rules.

⁽¹²⁾O.J. No. L373 of 31.12.1990, P.1.

⁽¹³⁾Updated by Council Directive No. 92/116/EEC-- O.J. No. L62 of 153.1993, P.1.

(7) Meat products must have been prepared in accordance with the requirements of Chapter III of the Second Schedule and, in the case of pasteurised or sterilised products in hermetically sealed containers or of prepared meals, comply with the requirements of Chapters VIII or Chapter IX, respectively of the Second Schedule.

(8) Meat products to be placed on the market must have undergone the establishment's own checks in accordance with Regulation 12.

(9) Meat products shall not be subject to ionising radiation.

(10) The use of food additives in meat products must comply with the terms of national legislation on the use of such additives.

8. (1) Notwithstanding the provisions of Regulation 7 (5) and in addition to the requirements of the other Regulations in Part III, a meat product may be placed on the market if it--

( a ) has been prepared by heating, curing, marinating or drying, which processes may be combined with smoking or maturing, possibly under specific microclimatic conditions, and which may have been associated with certain curing agents and food additives in accordance with Regulation 7 (10). The meat products may also be associated with other foodstuffs and condiments; or

( b ) is obtained from a meat product or meat preparation coming from an establishment approved by the Minister for such production.

(2) Until the expiry of the derogations provided for in Council Directive No. 71/118/EEC and Council Directive No. 9¼98/EEC⁽¹⁴⁾ of 29 July 1991, the Minister may authorise, subject to such conditions as he shall specify, the use of premises, tools and equipment used for the preparation of meat products from or with meat bearing the EC health mark for the preparation of meat products from or with meat which does not bear that mark.

⁽¹⁴⁾O.J. No. L268 of 24.9.1991, P.105.

9. (1) A person shall not place on the market meat products unless they bear one of the following marks--

( a ) the EC health mark, in the case of establishments approved under Regulation 4;

( b ) a national health mark where the raw material used meets the requirements of paragraph 1 (2) of Chapter III of the Second Schedule;

( c ) until 31 December 1995, a national health mark where the establishment is awaiting classification under paragraph (5).

(2) A health mark, which must accord with the requirements of Chapter VI of the Second Schedule, must be printed on the label or affixed to the product or the wrapping.

(3) The procurement, printing or reprinting of labels or marks under this Regulation for use by an approved establishment must be authorised by an authorised officer.

(4) The meat products referred to in paragraph (1) (b) and (c) cannot be sent to the territory of another Member State and may only be marketed within the State.

(5) All establishments producing meat products must apply to the Minister for classification either under Regulation 4 or 6.

(6) It is the responsibility of the owner or person in charge of an establishment to ensure that the provisions of this Regulation are followed.

10. (1) The storage, handling and transportation of meat products must be carried out in accordance with Chapter VII of the Second Schedule and if they are stored in a cold store separate from the establishment, that store must have been approved by the Minister in accordance with Article 10 of Council Directive 64/433/EEC.

(2) Consignments of meat products must be accompanied during transportation by either a health certificate or by a commercial document, whichever the Minister requires. It must be made available on request by an authorised officer.

(3) Any person who sends or receives a consignment of meat products accompanied by a commercial document or a health certificate, must retain a copy of that document or certificate and must make it available for inspection when requested by an authorised officer, for a period of at least one year after receipt or sending.

(4) An application for a health certificate required for the purposes of compliance with these Regulations shall be made to an authorised officer and shall be in such form and contain such particulars as the Minister may require and, unless the Minister otherwise agrees, such an application shall be received by the authorised officer to whom it is made not later than the day, being a day which is not a Saturday, Sunday or a bank or public holiday, preceding the day on which the certificate is required by the applicant.

(5) A person shall not supply false or misleading particulars to an authorised officer for the purpose of obtaining a health certificate or shall not include false or misleading particulars in a commercial document.

11. Wrapping packaging or labelling of meat products, within the meaning of Article 3 A.6 of the Annex to the Council Directive, may only be carried out in accordance with Chapter V of the Second Schedule in an establishment approved by the Minister in accordance with Regulation 4 or in a wrapping centre approved by the Minister for that purpose.

PART IV CONDITIONS RELATING TO ALL ESTABLISHMENTS

12. (1) A person who is for the time being the owner or person in charge of an establishment or rewrapping centre approved by the Minister in accordance with Regulations 4, 5, or 14 shall ensure that, at all stages of production or rewrapping, the specifications of these Regulations are complied with. To this end, the said persons must constantly carry out their own checks to ensure that--

( a ) the critical points in the establishment based on the processes used are identified; and

( b ) methods of monitoring and checking such critical points are established and implemented; and

( c ) such sampling, as is specified by an authorised officer, is carried out for the purpose of checking cleaning and disinfection methods and for checking compliance with the standards as may be set by the Minister from time to time; all samples shall be analysed in a laboratory approved annually by the Minister for the purposes of these Regulations; and

( d ) a written or registered record of the information required under subparagraphs (a), (b) and (c) is kept for examination, upon request, by an authorised officer for a period of at least two years. This period may be reduced to six months after the minimum conservation date of the product in the case of the products referred to in paragraph (2); and

( e ) the conditions as laid down in Regulation 9 regarding the application of the health mark, are adhered to; and

( f ) the Minister is notified immediately when the laboratory analysis of the samples, referred to in subparagraph (c), or any other information reveals a serious health risk; and

( g ) in the event of an immediate human health risk, referred to in subparagraph (f), the withdrawal from the market of the quantity of products to which the sample refers and any other products obtained in technologically similar conditions and which are likely to present the same risk. This withdrawn quantity must stay under the supervision and control of the Minister until in accordance with a notice issued by an authorised officer--

(i) it is destroyed, or

(ii) used for purposes other than human consumption, or

(iii) as may be directed in the said notice, reprocessed, under the terms of the European Communities (Disposal, Processing and Placing on the Market of Animal By-Products) Regulations, 1994 ( S.I. No. 257 of 1994 ); and

( h ) the requirements of subparagraphs (a) and (b) must be drawn up in conjunction with and to the satisfaction of an authorised officer, who may monitor compliance with the requirements of this paragraph as he considers necessary.

(2) For inspection purposes, the person who is for the time being the owner or person in charge of an establishment or rewrapping centre must ensure that the packaging of meat products which cannot be stored at ambient temperatures bears a clear and legible indication of the temperature at which the products must be transported and stored, as well as the minimum durability date or, in the case of microbiologically perishable products, the use-by date.

(3) The person who is for the time being the owner or person in charge of an establishment shall in accordance with the directions of an authorised officer and subject to any time limits that he may specify, arrange a staff training programme enabling workers, who have not, in the opinion of the authorised officer, already received acceptable training, to satisfy the hygiene standards appropriate to that type of production.

(4) An authorised officer may analyse the results of the checks provided for in paragraph (1). He may, on the basis of these analyses, conduct further examinations at all stages of production and on the products.

(5) An authorised officer may instruct the owner or person in charge of an establishment to carry out an increased number of tests.

(6) Where an authorised officer finds a failure to comply with hygiene rules laid down in these Regulations or the Council Directive or finds obstacles to an adequate health inspection, he may require the owner or person in charge of the establishment to remedy such defects as he may specify within a specified period. The owner or person in charge of an establishment shall rectify any shortcomings notified to him by an authorised officer under this Regulation.

(7) Where the owner or person in charge fails to carry out any instruction issued by an authorised officer under paragraph (6) or where an authorised officer considers that there is a serious hygiene risk in an establishment, he may--

(i) require the owner or person in charge of the establishment or premises to reduce the rate of production; or

(ii) require the owner or person in charge to temporarily suspend the type of production in question; or

(iii) remove the labels and seals bearing the health mark.

PART V PREPARED MEALS AND OTHER PRODUCTS OF ANIMAL ORIGIN

13. Prepared meals (other than prepared meat meals) obtained from raw materials of animal origin other than those referred to in Article 2 (b) of the Annex to the Council Directive where they are manufactured in an establishment approved by the Minister in accordance with Regulation 4 or 14 and where they are intended to be placed on the market for human consumption must meet the specific requirements laid down in Chapter IX of the Second Schedule.

14. (1) Subject to the provisions of paragraph (2), the Minister may, on application, approve an establishment for the preparation and storage of other products of animal origin provided he is satisfied that the establishment meets the standards laid down in the First Schedule and the Third Schedule.

(2) The Minister may, until 31 December 1995, approve establishments manufacturing products of animal origin which do not meet all the requirements set out in paragraph (1), on foot of an application to the Minister by the owner or person in charge of such an establishment. These establishments may be granted a derogation, at the discretion of the Minister, from some of the structural requirements laid down in Chapter I of the First Schedule and in Chapters II (A) and III of the Third Schedule provided the Minister is satisfied that the establishment meets the remaining requirements set down in paragraph (1) of this Regulation.

(3) Other products of animal origin may be placed on the market provided they--

( a ) are obtained in an establishment approved by the Minister under paragraph (1) or (2);

( b ) are manufactured in accordance with the conditions laid down in the Third Schedule;

( c ) are inspected as provided for in Regulation 18;

( d ) are accompanied on transportation, as provided for in Regulation 10, by a commercial document or a health certificate specifying the origin of the products;

( e ) are imported from third countries in compliance with the requirements of Council Directive No. 92/118/EEC of 17 December 1992.

(4) An approval granted under this Regulation shall relate to the owner of the establishment who originally applied for the approval. This approval shall cease in the event of the establishment being sold, ceasing trading or operation, or in the event of the death of the owner or the owner being adjudged bankrupt. Approval will also cease where an incorporated body is for any reason dissolved.

PART VI MINISTERIAL APPROVAL, INSPECTION AND SUPERVISION

15. (1) The Minster may attach conditions, as he sees fit, to an approval granted under Regulations 4, 5 or 14, or subsequently, and may amend or revoke a condition attached to the approval and shall notify the owner or person in charge of the establishment or rewrapping centre concerned in writing of the conditions, amendment or revocation concerned.

(2) The Minister may, if he is satisfied that the relevant provisions of these Regulations are not being complied with in relation to an establishment or rewrapping centre, refuse to approve the establishment or rewrapping centre and shall notify the owner or person in charge of the establishment or rewrapping centre in writing of the refusal and the reasons for such refusal.

(3) In the event of continued non compliance with these Regulations or failure by the owner or person in charge of an approved establishment or rewrapping centre to take the measures required under these Regulations the Minister may either temporarily suspend or revoke an approval.

(4) The Minister shall not--

( a ) revoke or suspend an approval given under Regulations 4, 5 or 14, or

( b ) refuse to approve an establishment or rewrapping centre on foot of an application, without--

(i) notifying the holder of, or applicant for, the approval of his intention to revoke or suspend or refuse the approval, as the case may be; and

(ii) specifying his reason for the intended revocation or suspension or refusal, as the case may be; and

(iii) affording the holder of, or the applicant for, the approval an opportunity of making representations or having representations made on his behalf within 14 days, to the Minister in relation to the proposed revocation or suspension or refusal, as the case may be.

(5) Where an approval under Regulations 4, 5 or 14 in respect of an establishment or rewrapping centre is suspended or revoked, the owner or person in charge of that establishment or rewrapping centre shall not produce, place on the market, supply, sell or use products originating from that establishment or rewrapping centre subsequent to the date of revocation or suspension, as the case may be, except with the approval of the Minister.

(6) The Minister may restore approval, if approval has been suspended in accordance with paragraph (3), in instances where--

( a ) the owner or person in charge of the suspended establishment or rewrapping centre has rectified the shortcomings notified to him by the Minister, and

( b ) the tests or checks carried out by an authorised officer confirm the safety of the meat products and other products of a animal origin emanating from the suspended establishment or rewrapping centre, and

( c ) the Minister is satisfied that the suspended establishment or rewrapping centre will fully comply with the requirements of Regulation 12.

16. (1) Where in relation to any meat products or other products of animal origin intended for human consumption, an authorised officer forms an opinion that there is a risk to public or animal health--

( a ) he may seize any meat products or other products of animal origin, or

( b ) he may serve or cause to be served on any person who is the owner of the meat products or other products of animal origin or an importer, or exporter of such products or the person who appears to such officer to be in control for the time being of such products a notice requiring either the owner, importer, exporter, or person in control for the time being of the meat products or other products of animal origin, that such products--

(i) be destroyed in such manner and at such place as the authorised officer shall direct, or

(ii) be used or disposed of in such manner as the authorised officer shall direct, and

(iii) any costs pertaining to action required under subparagraphs (i) and (ii) will be borne by the person on whom the notice is served,

(2) A requirement contained in a notice may specify a time limit within which it is to be complied with.

(3) A requirement specified in a notice served under paragraph (1) (in this paragraph referred to as "the earlier notice") may be modified or withdrawn in a further such notice and in that event the earlier notice shall have effect subject to such modification or withdrawal.

(4) A notice may require the owner, importer, exporter, or person in control for the time being of the meat products or other products of animal origin as the case may be to choose between two or more of the requirements specified in the notice.

(5) A notice referred to in paragraph (1) may be served on the owner, importer, exporter, or person in control for the time being of the meat products or other products of animal origin as the case may be by delivery of it by hand, or by sending it by prepaid registered post to or by leaving it at his last known place of abode or business.

(6) ( a ) An owner, importer, exporter or person in control for the time being of meat products or other products of animal origin may appeal within 7 days of the seizure of the meat products or other products of animal origin or service of the notice under paragraph (1) to the Judge of the District Court having jurisdiction in the District Court District where such products are situated or to the Judge of the District Court having jurisdiction in the District Court District where the person bringing the appeal ordinarily resides or carries on business on the grounds that the seizure or the notice or any of the terms thereof are not justified having regard to the provisions of these Regulations.

( b ) An appeal made pursuant to subparagraph (a) may be heard at any sitting of the District Court within the appropriate District Court District.

( c ) (i) Notice of an appeal made pursuant to subparagraph (a) shall be served on the Minister and the said notice shall be served at least 48 hours prior to the hearing of the appeal by serving it on the Minister or by leaving it at the place and in the manner specified in the notice issued under this Regulation;

(ii) the notice of appeal shall contain a statement of the grounds upon which it is alleged that the seizure or the notice or any of the terms thereof are not justified.

( d ) A copy of the notice of appeal shall be lodged with the District Court Clerk in the manner specified in the notice issued pursuant to paragraph (1), at least 48 hours prior to the hearing of the appeal.

( e ) The Minister shall, as well as the appellant, be entitled to be heard and to adduce evidence at the hearing of an appeal brought under paragraph (6) of this Regulation in opposition to an appeal made pursuant to this Regulation.

(7) On the hearing of an appeal under this Regulation a Judge of the District Court may, at his discretion, confirm, modify or annul the action taken under paragraph (1).

(8) ( a ) No person, including a person upon whom a notice has been served under paragraph (1), shall deal with the meat products or other products of animal origin concerned other than in accordance with the terms of the notice.

( b ) In the event of an appeal against the terms of a notice referred to in subparagraph (a), pursuant to paragraph (6), no person, including the person appealing, shall deal with the meat products or other products of animal origin concerned pending the determination of the appeal other than in accordance with such directions as shall be given in writing to the appellant by an authorised officer.

( c ) Where the terms of a notice referred to in subparagraph (a) are confirmed with or without modification by the Judge of the District Court hearing the appeal made under the said paragraph (6) no person, including the person who made the appeal, shall deal with the meat products or other products of animal origin concerned other than in accordance with such notice as confirmed.

(9) ( a ) where--

(i) an owner, importer, exporter or a person for the time being in control of the meat products or other products of animal origin fails to comply with the terms of a notice served upon him under paragraph (1) within the time specified therein, or

(ii) an authorised officer has reasonable grounds for believing that the terms of a notice served under paragraph (1) will not be complied with, or

(iii) a notice served under paragraph (1) has been confirmed with or without modification under paragraph (7) and the notice has not been complied with, or

(iv) an authorised officer has reasonable grounds for believing that the terms of a notice served under paragraph (1) which has been confirmed with or without modification under paragraph (7) will not be complied with or,

(v) pending the determination of an appeal made pursuant to subparagraph (a) of paragraph (6), an authorised officer has reasonable grounds for believing that directions given pursuant to paragraph (8) have not been or shall not be complied with,

an authorised officer may at any time seize the meat products or other products of animal origin at such premises or place as he thinks fit in the circumstances of the case.

( b ) In relation to any seized meat products or other products of animal origin, an authorised officer may destroy it, or cause it to be destroyed in such manner and at such place as the authorised officer shall direct, or such products may be used or disposed of in such manner as the authorised officer shall direct.

( c ) Any profits arising out of the disposal of the products referred to subparagraph (b) shall be paid to the owner of such products less any expenses incurred in connection with the said disposal.

(10) The costs of disposal or destruction of the meat products or other products of animal origin under this Regulation shall, subject to the provisions of subparagraph (9) (c), be recoverable by the Minister as a simple contract debt in any court of competent jurisdiction from the person who was the owner of these products at the time the disposal or destruction was carried out.

(11) In this Regulation--

"importer" and "exporter" includes any person who, whether as owner, consignor, consignee, agent or broker is in possession of or in any way entitled to the custody or control of the meat products or other products of animal origin which is being or has been imported into or exported from the State.

17. (1) Subject to the provisions of paragraph (2), the Minister in approving an establishment or rewrapping centre in accordance with Regulation 4 or 5, shall allocate an approval number to the establishment or rewrapping centre and shall notify the owner or person in charge of the establishment, or rewrapping centre in writing of the approval and of the number.

(2) The Minister may allocate a single approval number:

( a ) where an establishment or rewrapping centre processing or rewrapping products obtained from or with raw materials covered by several of the Directives referred to in the Fourth Schedule;

( b ) where an establishment is located on the same site as an establishment approved, by the Minister, in accordance with one of the Directives referred to in the Fourth Schedule.

(3) All establishments approved by the Minister under Regulation 14 shall be given a specific official number for inspection purposes and in order to be able to trace the establishment of origin of the products concerned. However, where production of other products of animal origin takes place in an establishment adjacent to a slaughterhouse approved by the Minister in accordance with Council Directive 64/433/EEC, the approval number of the slaughterhouse shall, provided the requirements of these Regulations are complied with, be extended to cover the establishment in question.

18. (1) The Minister may appoint such and so many persons as he thinks fit to be authorised officers for the purposes of these Regulations.

(2) An authorised officer shall be furnished with a warrant of his appointment by the Minister as an authorised officer and when exercising any power conferred on him by these Regulations such officer shall, if required by any person affected, produce the warrant to that person.

(3) An authorised officer or an expert from the European Commission, within the meaning of Article 12.1 of the Annex to the Council Directive, may at all reasonable times enter an establishment or rewrapping centre approved under these Regulations or for which an application for approval has been received for the purposes of carrying out inspections and supervision as required by these Regulations and the Council Directive.

(4) An authorised officer may at all reasonable times enter an approved establishment or rewrapping centre or any other premises or place in which he has reasonable grounds for believing that meat products or other products of animal origin are being produced for human consumption or for placement on the market in contravention of these Regulations and the Council Directive.

(5) An authorised officer shall have at all times free access to all parts of an establishment, rewrapping centre or premises and to accounting or other documents which enable the premises or holding of origin of the raw materials to be traced and for any other purpose of these Regulations.

(6) An authorised officer may:

( a ) make such examinations, tests and inspections at all stages of production and on any products, and

( b ) inspect, take or take copies of or extracts from any books, documents, or other records as he finds in the course of his inspection, and

( c ) take such reasonable samples of any meat product or other product of animal origin, which he finds in the course of his inspection,

as he may consider appropriate for the purposes of these Regulations and the Council Directive.

PART VII CERTIFICATION

19. (1) A person shall not print or cause to be printed, order, import, purchase, sell, offer or expose for sale a certificate or any document purporting to be or in any way resembling a certificate save with the consent in writing of the Minister.

(2) A person shall not have in his possession or under his control a certificate or any document purporting to be or in any way resembling a certificate

unless he is--

(i) an authorised officer or an officer of the Minister, or

(ii) a person who is in possession or control of the certificate or document with the consent in writing of the Minister, or

(iii) a person who is in possession or control of the certificate or document, in accordance with the provisions of these Regulations.

(3) A person shall not make or cause to be have made, order, import, purchase, sell, offer or expose for sale any instrument for affixing a health mark on meat products in accordance with Regulation 9, or any instrument for affixing a health mark in accordance with Regulation 9 or any certificate, document, wrapping label, carton or other thing, save in accordance with these Regulations.

(4) A person shall not apply a health mark or anything purporting to be a health mark to a certificate or a commercial document except in accordance with these Regulations.

(5) A person shall not procure by fraud or by misrepresentation, forge or without lawful authority or excuse, alter or tamper with, any document purporting to be a certificate or a commercial document or any other document purporting to be issued under these Regulations or for the purposes of the Council Directive nor utter any such certificate or document knowing it to be procured by fraud or by misrepresentation, forged, altered or tampered with.

(6) Nothing in paragraph (1) shall be construed as prohibiting the importation of a certificate where such importation is for the purpose only of complying with these Regulations.

PART VIII MISCELLANEOUS PROVISIONS

20. (1) An offence under these Regulations may be prosecuted by the Minister.

(2) Any person who contravenes a provision of these Regulations shall be guilty of an offence.

(3) If any person fraudulently--

( a ) tampers or otherwise interferes with any meat, meat products, or other products of animal origin so as to procure that any sample of it taken under these Regulations does not correctly represent, the meat, meat products or other products of animal origin,

( b ) tampers or otherwise interferes with any sample taken under these Regulations,

that person shall be guilty of an offence.

(4) Any person who obstructs or otherwise interferes with an authorised officer in the exercise of a power conferred on him by these Regulations shall be guilty of an offence.

(5) 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 have been facilitated by any neglect on the part of, any director, manager, secretary or other official of such body, each such person shall also be guilty of an offence.

21. A person 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 twelve months or to both such fine and such imprisonment.

22. The provisions of these Regulations and the Council Directive shall be applicable in lieu of sections 10 , 11 , 12 , 13 , 21 and 22 of the Pigs and Bacon Act, 1935 (No. 24 of 1935) and sections 33 and 34 of the Slaughter of Cattle and Sheep Act, 1934 (No. 42 of 1934), in cases to which these Regulations apply. The following Orders and Regulations are hereby revoked

( a ) Pigs and Bacon Act, 1935 (Part II) (No. I) Regulations, 1935 ( S.I. No. 245 of 1935 );

( b ) Bacon (Production from Carcases of Pigs Slaughtered in Licensed Slaughter Premises) Order, 1936 ( S.I. No. 142 of 1936 );

( c ) Meat (Regulations of Import) Order, 1969, ( S.I. No. 108 of 1969 ).

23. Notwithstanding the provisions of Regulation 22, the--

( a ) Pigs and Bacon Act, 1935 (Part II) Regulations, 1965 ( S.I. No. 113 of 1965 );

( b ) Pigs and Bacon Act, 1935 (Part II) (Amendment) Regulations, 1980 ( S.I. No. 154 of 1980 );

( c ) Pigs and Bacon Act, 1935 (Part II) (Amendment) Regulations, 1985 ( S.I. No. 259 of 1985 );

shall continue in force and shall apply to establishments approved by the Minister in accordance with Regulation 4 as if they were licensed under the Pigs and Bacon Act, 1935 (No. 24 of 1935).

FIRST SCHEDULE

General Conditions

CHAPTER I

General Conditions for Approval of Establishments

Establishments shall have at least the following facilities:

1. working areas of sufficient size for work to be carried out under adequate hygienic conditions. Their design and layout shall be such as to preclude contamination of the raw materials and the products referred to in these Regulations;

2. in areas where the raw materials are handled, prepared and processed and the products referred to in these Regulations are manufactured:

( a ) solid, waterproof flooring which is easy to clean and disinfect and laid in such a way as to facilitate the drainage of the water to trapped drains;

( b ) walls which have smooth surfaces and are easy to clean, durable and impermeable, covered with a light-coloured, washable coating up to a height of at least two metres, or at least storage height in refrigeration and storage rooms;

( c ) ceilings or roof linings which are easy to clean;

( d ) doors in non-corrodible materials which are easy to clean;

( e ) adequate ventilation and, where necessary, good steam and watervapour extraction facilities;

( f ) adequate natural or artificial lighting;

( g ) an adequate number of facilities with hot and cold running water, or water pre-mixed to a suitable temperature, for cleaning and disinfecting hands. In work rooms and lavatories, taps must not be hand-operable. These facilities must be provided with cleaning and disinfecting products and hygienic means of drying hands;

( h ) facilities for cleaning tools, equipment and utensils;

3. in rooms where the raw materials and the products covered by these Regulations are stored, the same conditions as those at paragraph 2 apply, except in:

( a ) chilling and refrigeration rooms, where a floor which is easy to clean and disinfect, laid in such a way as to facilitate the draining of water is sufficient, and

( b ) freezing and deep-freezing rooms, where waterproof and rotproof flooring which is easy to clean is sufficient,

in that case, a sufficiently powerful refrigeration plant to keep the raw materials and products at the temperatures specified in these Regulations must be available.

The use of wooden walls in the rooms referred to in sub-paragraph (b) does not constitute grounds for withdrawing approval provided they were built before 1 January 1983.

The capacity of the store rooms must be adequate to store the raw materials used and the products referred to in these Regulations;

4. facilities for hygienic handling and protection of raw materials and non-packaged or wrapped finished products during loading and unloading;

5. appropriate arrangements for protection against pests including insects, rodents and birds;

6. instruments and working equipment such as cutting tables, containers, conveyor belts, saws and knives, intended to come into direct contact with raw materials and products made of corrosion-resistant material and easy to clean and disinfect;

7. special watertight, non-corrodible containers, with lids and fastners to prevent unauthorised persons from removing unfit material from them, in which to put raw materials or products not intended for human consumption, or a lockable room for such purposes if the quantities are large enough to necessitate this or if they are not removed or destroyed at the end of each stage of work. Where such raw materials or products are removed through conduits, these must be so constructed and installed as to avoid any risk of contamination of the other raw materials or products;

8. appropriate facilities for the cleaning and disinfecting of equipment and utensils;

9. a waste water disposal system which meets hygiene requirements;

10. a supply of potable water only, within the meaning of the European Communities (Quality of Water intended for Human Consumption) Regulations, 1988 ( S.I. No. 81 of 1988 ). However, the use of non-potable water may be authorised in exceptional cases for steam production, fire fighting and refrigeration equipment, provided that the pipes installed for this purpose preclude the use of this water for other purposes and present no direct or indirect risk of contamination of the product. Non-potable water pipes must be clearly distinguished from those used for potable water;

11. an appropriate number of changing rooms with smooth, waterproof washable walls and floors, wash basins and flush lavatories. The latter must not open directly on to work rooms. Wash basins must be equipped for hand-washing and have hygienic means of drying hands; washbasin taps must not be hand operable;

12. if the volume of products treated requires the regular or permanent presence of authorised officers, an adequately equipped lockable room must be available for their exclusive use;

13. a room or a secure place for the storage of detergents, disinfectants and similar substances;

14. a room or cupboard for storing cleaning and maintenance material;

15. adequate facilities for cleaning and disinfecting means of transport. However, such facilities are not compulsory if the means of transport are to be cleaned and disinfected in an establishment or premises which is acceptable to an authorised officer.

CHAPTER II

General Conditions of Hygiene

A. General conditions of hygiene applicable to premises, equipment and tools

1. Equipment and instruments used for working on raw materials and products, floors, walls and partitions, ceilings or roof linings or any other equipment must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for raw materials or products. Water for cleaning tools must be at a temperature of not less than +82°C.

2. No animals may enter the establishments. Rodents, insects and any other vermin in the premises or on the equipment must be systematically exterminated; rodenticides, insecticides, disinfectants and any other potentially toxic substances must be stored in premises or cupboards which are lockable; their use must not present any risk of contamination of the products.

3. Working areas, instruments and working equipment must be used only for work on products for which approval has been granted. However, following authorisation by an authorised officer, they may be used at the same time or other times for work on other foodstuffs fit for human consumption. This restriction does not apply to transport equipment used in premises where no work is done on raw materials or products covered by these Regulations.

4. Potable water, within the meaning of the European Communities (Quality of Water intended for Human Consumption) Regulations, 1988 ( S.I. No. 81 of 1988 ), must be used for all purposes. However, by way of exception, non-potable water may be used for steam production, fire-fighting and the cooling of equipment, provided that the pipes installed for the purpose preclude the use of such water for other purposes and present no risk of contamination of the raw materials and products.

5. Detergents, disinfectants and similar substances must be acceptable for use in establishments covered by these Regulations and used in such a way that they do not have adverse effects on the machinery, equipment, raw materials and products. Records and details must be kept of all chemicals used in the establishment in a form that is acceptable to an authorised officer. Their use must be followed by thorough rinsing of such instruments and working equipment with potable water, if so required. Products for maintenance and cleaning must be kept in the room provided for in paragraph 14 of Chapter I of this Schedule.

6. The spreading of sawdust or any other similar substance on the floor of the workrooms and storage rooms for the raw materials and products referred to in these Regulations is prohibited.

B. General conditions of hygiene applicable to staff

1. Absolute cleanliness is required of staff. Specifically:

( a ) staff must wear suitable clean working clothes and headgear which completely encloses the hair. This applies particularly to persons handling exposed, non-packed raw materials and products;

( b ) staff assigned to the handling and preparation of raw materials and products must be required to wash their hands at least each time work is resumed and in cases where contamination has occurred, wounds to the hands must be covered by a waterproof dressing;

( c ) smoking, spitting, chewing gum, eating and drinking in rooms where raw materials and products are worked on or stored is prohibited.

2. The owner or person in charge of an establishment shall take all the requisite measures to prevent persons liable to contaminate raw materials and products from handling them, until there is evidence that such persons can do so without risk.

Any person who is a possible source of contamination, in particular through pathogenic agents, shall be prohibited from working with or handling fresh meat or meat products.

When recruited, any person working on and handling raw materials and products shall be required to prove, by a medical certificate, that there is no impediment to such employment. The medical certificates shall be renewed every year, unless another staff medical check-up scheme can offer equivalent guarantees to the satisfaction of an authorised officer.

The owner or person in charge of an establishment shall ensure that these medical certificates are available for inspection on request by an authorised officer.

SECOND SCHEDULE

Special Conditions for Meat Products

CHAPTER I

Special Conditions for Approval of Establishments preparing Meat Products

1. In addition to the general requirements laid down in Chapter I of the First Schedule, establishments manufacturing, handling and wrapping meat products shall have at least:

( a ) suitable rooms large enough for the separate storage:

(i) of raw materials, under refrigeration; and

(ii) of meat products at ambient temperature or, where appropriate, depending on the nature of the products, under refrigeration;

on the understanding that non-packaged raw materials, meat products and other products of animal origin must be stored separately from packaged raw materials and products;

( b ) one or more appropriate large enough for the manufacture and wrapping of meat products. Provided these operations constitute a single production cycle complying with the requirements of these Regulations and guaranteeing the safety of the raw materials and finished products, and provided the design and dimensions of the manufacturing room allow, they may be carried out in the same room;

( c ) a room or a secure place for the storage of certain ingredients such as food additives;

( d ) a room for packaging, unless the conditions laid down for packaging in paragraph 3 of Chapter V of this Schedule are fulfilled, and for dispatch;

( e ) a room for the storage of wrapping and packaging materials;

( f ) a room for cleaning equipment and instruments, such as hooks and containers.

2. Depending on the type of product involved, the establishment must have:

( a ) a room or -- if, in the opinion of an authorised officer, there is no danger of contamination -- an area where packaging is removed;

( b ) a room or -- if, in the opinion of an authorised officer, there is no danger of contamination -- an area for thawing raw materials;

( c ) a cutting room;

( d ) a room or equipment for drying or maturing;

( e ) a room or equipment for smoking;

( f ) a room for desalting, soaking and any other treatment, particularly of natural guts, where these raw materials have not undergone such operations in the establishment of origin;

( g ) a room for the prior cleaning of the raw materials needed to prepare meat products;

( h ) a room for salting, if deemed necessary in the opinion of an authorised officer, with air-conditioning facilities to maintain the temperature provided for in paragraph 4 of Chapter II of this schedule;

( i ) a room for the prior cleaning, if deemed necessary in the opinion of an authorised officer, of meat products to be sliced or cut and wrapped;

( j ) a room, if deemed necessary in the opinion of an authorised officer, with air-conditioning facilities, for slicing or cutting and packaging of meat products intended for sale in pre-packed form;

( k ) the specific rooms provided for in the Third Schedule, where the products referred to therein are manufactured in the establishments referred to in this Chapter;

( l ) where the conditions laid down in paragraph 1 (b) are met, it may be decided following the agreement of an authorised officer, that some of these operations may be carried out in the same room.

Where the conditions laid down in paragraph 1 (b) are not met, operations which might constitute a health risk in the case of certain products manufactured simultaneously and operations associated with excessive heat production must be carried out in a separate room;

( m ) work-rooms and working instruments and equipment shall not be used for purposes other than work on fresh meat, meat products and meat preparations.

However, they may be used for the preparation of other foodstuffs either simultaneously or at different times, after authorisation by an authorised officer, provided that all appropriate measures are taken to prevent contamination of the products covered by these Regulations or adverse changes in them.

CHAPTER II

Special Conditions of Hygiene for Establishments preparing Meat Products

1. Rooms used for storing or working on foodstuffs other than meat or meat products, liable to form part of the composition of meat products, must be subject to the general rules on hygiene laid down in these Regulations.

2. Raw materials and the ingredients forming part of the composition of meat products as well as the products themselves and products of animal origin and their containers shall not come into direct contact with the ground and shall be handled under conditions which preclude any risk of contamination. Care must be taken to ensure that there is no contact between raw materials and finished products.

3. The use of wood is permitted in rooms in which meat products are smoked, cured, matured, pickled, stored or dispatched, when essential for technological reasons, provided there is no risk of the products being contaminated. Wooden pallets may be brought into the said rooms solely for transporting packaged meat or meat products and for no other purposes. In addition, the use of galvanised metals may be authorised by an authorised officer for the drying of hams and sausages, provided that they are not corroded and do not come into contact with the meat products.

4. The temperature in rooms or parts of rooms where work on meat, minced meat used as a raw material, meat products and meat preparations is carried out must ensure hygienic production; if deemed necessary in the opinion of an authorised officer, such rooms or parts of rooms must be provided with air-conditioning facilities.

During cutting, slicing and curing operations, rooms for cutting and curing must be kept at a temperature not exceeding 12°C, except in the case of the establishments referred to in Regulation 6.

However, in the case of other establishments an authorised officer may grant a derogation from this requirement where he considers such a derogation justified in the light of the technology used in preparing the meat product.

CHAPTER III

Requirements for Raw Material to be used for the Manufacture of Meat Products

1. (1) Subject to the provisions of paragraph (2) of this Chapter, meat which is to be used for the manufacture of meat products must:

( a ) come from an establishment approved in accordance with the Council Directives referred to in the Fourth Schedule and have been transported under satisfactory hygiene conditions in accordance with the said Council Directives,

( b ) from the time of its arrival in the processing establishment until the time of its use, be kept in accordance with the requirements of the Directives referred to in the Fourth Schedule,

(2) However, until 31 December 1995, meat obtained from establishments granted derogations under Council Directive 9¼98/EEC⁽¹⁵⁾ of 29 July 1991 may be held in approved establishments. Until that date, meat which does not comply with the conditions set out in the Directives referred to in the Fourth Schedule may be held in approved establishments only if it is stored in a place separate from meat marked with the EEC health mark; it must not be used in the same place or at the same time as meat which bears the EEC health mark. Meat products obtained from such meat must bear the national mark.

2. Minced meat and meat preparations, unless produced in the manufacturing room referred to in paragraph (1) (b) of Chapter I of this Schedule, must:

( a ) come from an establishment approved in accordance with the European Communities (Minced Meat) Regulations, 1994 ( S.I. No. 215 of 1994 ) and have been transported under satisfactory health conditions in accordance with that Council Directive; and

( b ) from the time of their arrival in the processing establishment until the time of their use. be kept in accordance with the requirements of the European Communities (Minced Meat) Regulations, 1994.

3. The inclusion of fishery products in the preparation of meat products is permitted where such products comply with the requirements of Council Directive 9¼93/EEC⁽¹⁶⁾ of 22 July 1991.

CHAPTER IV

Supervision of Production

1. Establishments shall be subject to supervision by authorised officers, who may carry out such checks and sampling as may be necessary to ensure that the requirements of these Regulations and of the Council Directive are met.

2. Authorised officers must have free access at all times to cold stores and all working premises to check that the provisions of these Regulations and the Council Directive are being complied with.

CHAPTER V

Wrapping, Packaging and Labelling

1. Wrapping, packaging and labelling must take place under satisfactory hygiene conditions in rooms provided for that purpose.

Without prejudice to the provisions of the European Communities (Materials and Articles intended to come into contact with Foodstuffs) Regulations, 1991 ( S.I. No. 307 of 1991 ), wrapping and packaging must comply with all the rules of hygiene, laid down in these Regulations, and be strong enough to protect the meat products effectively.

⁽¹⁵⁾O.J. No. L268 of 24.9.1991, P.105.

⁽¹⁶⁾O.J. No. L268 of 24.9.1991, P.15.

2. Wrapping or packaging may not be re-used for meat products, with the exception of certain special types of containers such as earthenware, glass or plastic containers which may be re-used after thorough cleaning and disinfecting.

3. Manufacture of meat products and packaging operations may take place in the same room if the packaging is as described in paragraph 2 and subject to an authorised officer being satisfied that the following conditions can be met:

( a ) the room must be sufficiently large and so equipped that the hygiene of the operations is assured;

( b ) the packaging and wrapping must be enclosed in a sealed protective cover immediately after manufacture; this cover must be protected from damage during transport to the establishment and stored under hygienic conditions in a room intended for that purpose;

( c ) the rooms for storing the packaging material must be free from dust and vermin and have no atmospheric connection with rooms containing substances which might contaminate meat, minced meat, meat preparations or meat products. Packaging must not be placed directly on the floor;

( d ) packaging must be assembled under hygienic conditions before being brought into the room. A derogation from this requirement may be granted by an authorised officer in the case of the automatic assembly of packaging, provided there is no risk of contamination of the meat products;

( e ) packaging must be brought to the room under hygienic conditions and used without delay. It may not be handled by staff handling unwrapped meat, minced meat, meat preparations or meat products;

( f ) immediately after packaging, the meat products must be placed in the storage rooms provided for that purpose.

4. In addition to the requirements of the European Communities (Labelling, Presentation and Advertising of Foodstuffs) Regulations, 1982 ( S.I. No. 205 of 1982 ), the following information shall be visible and legibly displayed on the wrapping or on the label of the meat products:

( a ) where it is not clear from the sales description of the product or from the list of ingredients the species from which the meat was obtained;

( b ) a reference, for example a batch number, permitting identification of a quantity of products obtained in technologically similar conditions and likely to present the same risk;

( c ) for packaging not intended for the final consumer, the date of preparation;

( d ) the sales description.

CHAPTER VI

Health Mark

1. Subject to the provisions of paragraph 3, meat products must carry a health mark. Marking must be carried out during or immediately after manufacture in the establishment or wrapping centre, in an easily visible place. The mark shall be legible, indelible and its characters easily distinguishable. The health mark may be applied to the product or to the wrapping, if the meat product is individually wrapped, or to a label affixed to this wrapping in accordance with paragraph 4 (c). However, where a meat product is individually wrapped and packaged, it will suffice for the health mark to be applied to the packaging.

2. Subject to the provisions of paragraph 3, where meat products marked in accordance with paragraph 1 are subsequently placed in a packaging, the health mark must also be applied to the packaging.

3. By way of derogation from paragraphs 1 and 2, the health marking of meat product in palletised consignments intended for further processing or wrapping in an approved establishment is not necessary provided that:

( a ) the said consignments containing the meat products bear the health mark in accordance with paragraph 4 (a) or (b) on the external surface; and

( b ) the recipient establishment maintains a separate record of the quantities, type and origin of meat products received in accordance with this paragraph; and

( c ) the destination and intended use of meat products are clearly indicated on the external surface of the outer packaging except when this is transparent.

However, where a consignment of wrapped products is contained in a transparent packaging, it is not necessary to health mark the packaging as long as the health mark on the wrapped products is clearly visible through the packaging.

4. The health mark must give the following particulars:

( a ) the EEC health mark shall consist of an oval mark containing in legible form and in printed capital letters the following information -- in the upper part, the letters "IRL", in the centre, the approval code of the meat products premises preceded by the letter "P", and in the lower part the letters "EEC";

( b ) where meat products are to be marketed bearing the national health mark, that mark shall consist of a square mark containing in legible form and in printed capital letters the following information -- in the upper part, the letters "IRL", in the centre the approval code of the meat products premises preceded by the letter "P", and in the lower part the letters "IRL";

( c ) the health mark may be applied to the product, wrapping or packaging by an ink stamp or by branding, or it may be printed on or applied to a label. If it is applied to the packaging, the mark must be destroyed when the package is opened. Non-destruction of this mark may be tolerated only when the packaging is destroyed by being opened. In the case of products in hermetically sealed containers, the mark must be indelibly applied either to the lid or to the can;

( d ) the health mark may also consist of an irremovable plate of resistant material complying with all the hygiene requirements and bearing all relevant information specified in subparagraphs (a) and (b).

CHAPTER VII

Storage and Transport

1. Meat products must be stored in the rooms provided for in paragraph 1 (a) of Chapter I of this Schedule. However, meat products which can be kept at ambient temperature may be stored in stores, of solid construction and easy to clean and disinfect, if approved by an authorised officer.

2. Meat products for which certain storage temperatures are indicated in accordance with Regulation 12 (2) must be maintained at those temperatures in rooms equipped with a recording thermometer or recording telethermometer.

3. Meat products must be dispatched in such a way that they are protected during transportation from anything which might contaminate or adversely affect them. For this purpose account shall be taken of the length of the journey, the means of transport employed and the weather conditions.

4. Meat products must, if the product so requires, be transported in vehicles equipped to ensure that they can be transported at the required temperatures and in particular that the temperatures indicated in accordance with Regulation 12 (2) are not exceeded.

CHAPTER VIII

Special Conditions for Pasteurised or Sterilised Products in Hermetically Sealed Containers

A. In addition to the conditions laid down in the First Schedule, establishments manufacturing pasteurised or sterilised products in hermetically sealed containers

1. must have:

( a ) a device for conveying empty cans hygienically to the work room;

( b ) equipment enabling cans to be thoroughly cleaned immediately before filling;

( c ) equipment for washing containers in potable water hot enough to remove grease after they have been hermetically sealed and before retorting;

( d ) a suitable room, area or installation for cooling and drying containers after heat treatment;

( e ) facilities for the incubation of samples taken from meat products packed in hermetically sealed containers;

( f ) adequate facilities for checking whether containers are hermetically sealed and undamaged;

( g ) in rooms or areas deemed necessary by an authorised officer, indicating thermometers or recording thermometers or recording telethermometers;

2. must ensure that:

( a ) hermetically sealed containers are removed from the heating equipment at a sufficiently high temperature to ensure rapid evaporation of humidity and are not touched by hand until completely dry;

( b ) containers in which gas appears to be present undergo a further examination;

( c ) the thermometers, recording thermometers or recording telethermometers are checked against calibrated thermometers or telethermometers;

( d ) containers are:

(i) rejected if damaged or badly made;

(ii) rejected or cleaned if they are dirty and, in the case of cans, thoroughly cleaned immediately before filling, by means of the cleaning equipment referred to in paragraph 1 (b); the use of stagnant water is not authorised;

(iii) if necessary, drained for a sufficiently long time after cleaning and before filling;

(iv) if necessary, washed in potable water, sufficiently hot to remove grease if appropriate, after they have been hermetically sealed and before retorting, by means of the equipment referred to in paragraph 1 (c);

(v) cooled, after heating, in water meeting the requirements of paragraph (e) in B;

(vi) handled, before and after heat treatment, in such a way that any damage or contamination is avoided.

B. The owner or person in charge of an establishment manufacturing meat products in hermetically sealed containers must also check by sampling that:

( a ) (i) a process is applied to meat products intended for storing at ambient temperature which results in an Fc value equal to or exceeding 3.00, unless the same stability of the product has been obtained by curing, or

(ii) that a heat treatment procedure is applied which is at least equivalent to pasteurisation, the parameters being approved by an authorised officer;

( b ) empty containers meet production standards;

( c ) checks on the daily output are carried out at intervals determined in advance, to ensure the efficacy of the sealing. To this end, suitable equipment must be available for examining perpendicular sections of the seams of the sealed containers;

( d ) the necessary checks are carried out, using in particular control markers to ensure that the containers have undergone adequate heat treatment;

( e ) the necessary checks are carried out to ensure that the cooling water contains a residual level of chlorine after use. A derogation from this requirement, may be granted, if the water fulfils the requirements of the European Communities (Quality of Water intended for Human Consumption) Regulations, 1988 ( S.I. No. 81 of 1988 );

( f ) seven-day incubation tests at 37°C or 10-day incubation tests at 35°C are carried out on preserved meat products in hermetically sealed containers which have undergone heat treatment;

( g ) pasteurised products in hermetically sealed containers satisfy criteria recognised by the Minister.

C. ( a ) The Minister may approve the addition of certain substances to the water used in retorts in order to prevent corrosion of cans and to soften and disinfect the water;

( b ) an authorised officer may allow the use of recirculated water for cooling heat-processed containers. Such water must be purified in accordance with the terms of the European Communities (Quality of Water intended for Human Consumption) Regulations, 1988 ( S.I. No. 81 of 1988 );

( c ) the recirculated water shall circulate in closed circuit so that it cannot be used for other purposes. However, where there is no risk of contamination, the water used for cooling containers and water from retorts may be used at the end of a working period for cleaning floors.

CHAPTER IX

Special Conditions for Meat-based Prepared Meals

In addition to the general conditions in the First Schedule and in Chapters I, II and III of this Schedule:

1. establishments manufacturing prepared meals must have a separate room for the preparation and wrapping of prepared meals; a separate room is not required where meat products and meat are handled at separate times, provided the rooms used for these operations are cleaned and disinfected between use for each type of product;

2. (a) the meat product contained in the prepared meal must, as soon as it has been cooked:

(i) either be immediately mixed with the other ingredients; in that event the time during which the temperature of the meat product is between 10°C and 63°C must be kept to a minimum;

(ii) or be refrigerated to 10°C or less before being mixed with the other ingredients;

( b ) the meat product and the prepared meal must be refrigerated to an internal temperature of + 10°C or less within a period of not more than two hours after the end of cooking and to the storage temperature as soon as possible. However, an authorised officer may authorise the establishment to derogate from the two-hour period where a longer period is justified for reasons connected with the production technology employed, provided that the safety of the end product is guaranteed;

( c ) the prepared meal must, where appropriate, be frozen or quick-frozen immediately after cooling;

3. labelling of products must comply with the European Communities (Labelling, Presentation and Advertising of Foodstuffs) Regulations, 1982 ( S.I. No. 205 of 1982 ). The list of ingredients, shall for the purposes of these Regulations, include an indication of the animal species. Prepared meals shall bear the date of manufacture very clearly on one of the outer surfaces of the wrapping in addition to the information already specified;

4. the results of the various checks to be carried out by the owner or person in charge of the establishment must be kept, so that they can be shown on receipt of any request from an authorised officer, for a minimum period of time specified by an authorised officer according to the durability of the product concerned.

THIRD SCHEDULE

Specific Hygiene Standards for the Manufacture of other Products of Animal Origin

CHAPTER I

General Conditions

The premises may be used for the production of products not intended for human consumption only under the following conditions:

( a ) raw materials unfit for human consumption must be stored in a completely separate room or separate reception area;

( b ) they must be processed in separate rooms using separate installations and equipment, except where the processing takes place in completely enclosed installation or equipment used exclusively for this purpose;

( c ) the final products from these raw materials must be stored in a different room or separate tanks which are labelled appropriately and must not go for human consumption.

CHAPTER II

Special Conditions for Rendered Animal Fats, Greaves and By-products

In addition to the conditions in the First Schedule, the following conditions apply:

A. Standards applicable to establishments collecting or processing raw materials

1. Centres for the collection of raw materials and further transport to processing establishments must be equipped with a cold store to store raw materials at a temperature of 7°C or less, unless the raw materials are collected and rendered within the time limit laid down in B. -- paragraphs (3) (b) and (c).

2. The processing establishment must have at least:

( a ) a cold store, unless the raw materials are collected and rendered within the time limits laid down in B.-- - paragraph (3) (b);

( b ) a room or place to receive raw materials;

( c ) an installation to facilitate the visual inspection of raw materials by an authorised officer;

( d ) if appropriate, an installation to crush raw materials;

( e ) equipment for the rendering of raw materials by heat or pressure or some other appropriate method;

( f ) containers or tanks in which the fat can be kept in liquid state;

( g ) apparatus for plastification or crystallisation of the fat to facilitate market preparation and packaging, unless the establishment dispatches liquid rendered animal fat only;

( h ) a dispatch room, unless the establishment dispatches melted animal fat only by means of tankers;

( i ) watertight containers for the containment and removal of raw materials unfit for human consumption;

( j ) if appropriate, suitable equipment for the preparation of products consisting of rendered animal fat mixed with other foodstuffs and/or seasonings;

( k ) if greaves are intended for human consumption, suitable facilities ensuring hygienic collection, wrapping and packaging and storage under the conditions laid down in B. -- paragraph (9).

B. Additional hygiene requirements relating to the preparation of rendered animal fat, greaves and by-products

1. Raw materials shall originate from animals which, after ante and post mortem inspection, have been found fit by an authorised officer for human consumption.

2. The raw materials shall consist of adipose tissues or bones found fit by an authorised officer for human consumption and which are reasonably free from blood and impurities. They must not show signs of deterioration and must be obtained under hygienic conditions.

3. ( a ) Subject to the provisions of sub-paragraphs (b) and (c), for the preparation of rendered animal fat, only adipose tissues or bones, collected at slaughterhouses, cutting plants or meat processing establishments shall be used. Raw materials shall be transported and stored until rendered in hygienic conditions and at an internal temperature of 7°C or less;

( b ) by way of derogation from subparagraph (a), raw materials may be stored and transported unrefrigerated provided that they are rendered within twelve hours after the day on which they were obtained;

( c ) by way of derogation from subparagraph (a), raw materials collected at retail shops or in premises adjacent to sales points, where the cutting and the storage of meat or poultrymeat is performed for the sole purpose of supplying the final consumer directly, may be used for the preparation of rendered animal fat, provided they are in satisfactory hygienic condition and properly packed. When the raw materials are collected daily the temperature requirements laid down in sub-paragraphs (a) and (b) must be complied with. If the raw materials are not collected daily, they must be refrigerated immediately after they have been obtained.

4. Vehicles and containers for the collection and transport of raw materials must have smooth internal surfaces, easy to wash, clean and disinfect and vehicles must be adequately covered. Vehicles for refrigerated transport must have been designed in such a way that the temperature required can be maintained throughout the period of transport.

5. Before rendering, raw materials shall be inspected by the owner or person in charge for the presence of raw materials unfit for human consumption, or extraneous matter. When present these must be removed.

6. Raw materials shall be rendered by heat, pressure or any other appropriate method, followed by separation of the fat by decantation, centrifugation, filtration or any other appropriate method. The use of dissolvents is prohibited.

7. Rendered animal fat which is prepared in accordance with paragraphs 1, 2, 3, 5 and 6 may for the production of raw materials be refined in the same or another establishment to improve its physico-chemical quality when the fat for refining satisfies the standards laid down in paragraph 8.

8. Rendered animal fat, depending on type, shall meet the following standards:

9. Greaves intended for human consumption shall be stored:

(i) when rendered at a temperature of 70°C or less: at a temperature of less than 7°C for a period not exceeding 24 hours or at -18°C or lower;

(ii) when rendered at a temperature of more than 70°C and having a moisture content of 10 per cent (m/m) or more:

( a ) at a temperature of less than 7°C for a period not exceeding 48 hours or at a time/temperature ratio offering an equivalent guarantee,

( b ) at -18°C, or lower;

(iii) when rendered at a temperature of more than 70°C and having a moisture content of less than 10 per cent (m/m): no specific requirement.

CHAPTER III

Special Conditions for Stomachs, Bladders and Intestines

In addition to the conditions in the First Schedule, and Chapters I, II and III of the Second Schedule, establishments treating stomachs, bladders and intestines must comply with the following conditions:

1. premises, instruments and tools must be used only for work on the products concerned; there must be a clear division between clean and unclean sections;

2. the use of wood is forbidden; however the use of wooden pallets is authorised for the transport of the containers of the products concerned;

3. premises must be provided for storing wrapping and packaging materials;

4. wrapping and packaging must take place under hygienic conditions in a room or in a place intended for that purpose;

5. products which cannot be kept at ambient temperature must be stored until their dispatch in premises intended for that purpose. In particular, products which are not salted or dried must be kept at a temperature not exceeding 3°C;

6. Raw materials must be transported from the slaughterhouse of origin to the establishment under satisfactory hygiene conditions and, where appropriate in the light of the period between slaughter and the collection of the raw materials, refrigerated. Vehicles and containers for transporting such materials must have smooth internal surfaces which are easy to wash, clean and disinfect. Vehicles for refrigerated transport must have been designed in such a way that the temperature required can be maintained throughout the period of transport.

FOURTH SCHEDULE

Definition of Meat

Meat as defined in--

1. Article 2 (a) of Council Directive No. 64/443/EEC as amended by Council Directive No. 9¼97/EEC⁽¹⁾ and Article 1 of Council Directive No. 72/461/EEC⁽²⁾ in relation to fresh red meat.

2. Article 2 of Council Directive No. 72/462/EEC ⁽³⁾ in relation to fresh red meat from third countries.

3. Article 2 of Council Directive No. 88/657/EEC⁽⁴⁾ in relation to minced meat and meat preparations.

4. Article 2 (1) and (2) of Council Directive No. 9¼95/EEC⁽⁵⁾ in relation to rabbit and farmed game meat.

5. Article 2 (1) (d) and meeting the requirements of Articles 3 and 5 of Council Directive No. 92/45/EEC⁽⁶⁾ in relation to wild-game meat.

6. Article 2 of Council Directive No. 71/118/EEC as amended by Council Directive No. 92/116/EEC⁽⁷⁾ in relation to poultry.

GIVEN under my Official Seal, this 18th day of May, 1995.

IVAN YATES,

Minister for Agriculture, Food and

Forestry.

EXPLANATORY NOTE.

These Regulations transpose the EC Directives which lay down the health rules for the production and marketing of meat products and other products of animal origin intended for human consumption or for the preparation of other foodstuffs. They cover the standards of manufacturing premises and the operational procedures for hygienic production.

⁽¹⁾O.J. No. L268 of 24.9.1991, P.69.

⁽²⁾O.J. No. L302 of 31.12.1972, P.24.

⁽³⁾O.J. No. L302 of 31.12.1972, P.28.

⁽⁴⁾O.J. No. L382 of 31.12.1988, P.3.

⁽⁵⁾O.J. No. L268 of 24.9.1991, P.41.

⁽⁶⁾O.J. No. L268 of 14.9.1992, P.35.

⁽⁷⁾O.J. No. L62 of 15.3.1993, P.1.