S.I. No. 243/1996 - European Communities (Minced Meat and Meat Preparations) Regulations, 1996

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. 94/65/EC (1) of 14 December 1994 hereby make the following Regulations:—

⁽¹⁾ O.J. No. L368 of 31.12.1994, p.10.

Part I Preliminary

1 Title and Commencement

1. (1) These Regulations may be cited as the European Communities (Minced Meat and Meat Preparations Regulations), 1996.

(2) These Regulations shall come into operation on the fourteenth day of August 1996.

2 Interpretation

2. (1) In these Regulations -

"authorised officer" has the meaning assigned to it by Regulation 15;

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

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

"consumer" means a person who buys minced meat or meat preparations -

( 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. 94/65/EC of 14 December 1994;

"establishment" means a production plant or an independent production unit;

"independent production unit" means a production plant which is not located on the premises of, or in an annex to, an establishment approved by the Minister in accordance with Council Directive 64/433/EEC ⁽²⁾, the European Communities (Fresh Poultrymeat) Regulations, 1996 (S.I. No., 3 of 1996) or the European Communities (Meat Products and Other Products of Animal Origin) Regulations, 1995 ( S.I. No. 126 of 1995 ) and which fulfils the requirements of paragraph 2 of Chapter 1 or paragraph 2 of Chapter III of the First Schedule to these Regulations;

⁽²⁾ As Amended by Council Directive No. 91/497/EEC of 29 July 1991 - O.J. No. L268 of 24.9.1991, p.69 and Council Directive 95/23/EC of 22 June 1995 O.J. No. L243 of 11.10.1995, P.7.

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

"premises" includes land, with or without buildings;

"production plant" means any plant in which minced meat or meat preparations are produced:

(a) which is located in a cutting plant and satisfies the requirements of Chapter I of the First Schedule;

(b) which in the case of the production of meat preparations, is located in a plant fulfilling the requirements of Chapter III of the First Schedule;

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

"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;

"trade" means trade between Member States of the European Communities.

(2) 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) 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 General Conditions and Exemptions

3. (1) Subject to the provisions of paragraphs (2) and (3), a person shall not produce or place on the market minced meat and meat preparations other than in compliance with these Regulations and the Council Directive.

(2) The requirements of these Regulations and the Council Directive shall not apply to meat preparations and minced meat which are produced in retail shops or in premises adjacent to sales points, with a view to sale there directly to the consumer.

(3) The provisions of these Regulations and the Council Directive shall not apply to mechanically recovered meat for industrial use, within the meaning of Article 1.3 of the Council Directive, which undergoes heat treatment in establishments approved in accordance with the European Communities (Meat Products and Other Products of Animal Origin) Regulations, 1995 ( S.I. No. 126 of 1995 ).

Part II Production of Minced Meat for Placement on the Market

A. Minced Meat intended for Trade Conditions of Approval

4 ..

4. (1) The Minister may, on application, approve an establishment for the production of minced meat intended for trade provided he is satisfied that it meets the requirements of Chapter I of the First Schedule and the requirements of Regulations 5 and 6.

(2) Where approval is sought under these Regulations for a plant which forms an integral part of an establishment already approved by the Minister under Council Directives 64/433/EEC, the European Communities (Fresh Poultry Meat) Regulations, 1996 ( S.I. No. 3 of 1996 ), the European Communities (Meat Products and Other Products of Animal Origin) Regulations, 1995 ( S.I. No. 126 of 1995 ) or the European Communities (Wild Game) Regulations, 1995 ( S.I. No. 298 of 1995 ), the Minister may allow the premises, equipment and installations for staff and, generally all 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 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.

5 Conditions for Placing on the Market

5. Minced meat intended for trade must be prepared, in an establishment approved by the Minister in accordance with Regulation 4, from fresh meat from bovine animals, pigs, sheep or goats and presented in the form of minced meat, which meets the following requirements:

(a) it must be prepared from striated muscle, except heart muscle, which meets the requirements of:

(i) Article 3 of Directive 64/433/EEC; or

(ii) Council Directive No. 72/462/EEC ⁽³⁾;

⁽³⁾ O.J. No. L302 of 31.12.1972, p.28 (as amended).

and has been inspected in accordance with the European Communities (Importation of Animals and Animal Products from Third Countries) Regulations, 1994 ( S.I. No. 255 of 1994 ).

In the case of fresh pigmeat, it must furthermore have been examined for trichinae in accordance with Article 2 of Council Directive No. 77/96/EEC ⁽⁴⁾ of 21 December 1976 or have undergone cold treatment as referred to in Annex IV to that Directive;

⁽⁴⁾ O.J. No. L26 of 31.1.1977, p.67.

(b) it must be prepared, in accordance with the requirements of Chapter II of the First Schedule, in an establishment approved by the Minister under the terms of Regulation 4;

(c) it must be marked with a Community health mark and labelled in accordance with Chapter V of the First Schedule;

(d) it must be wrapped, packaged and stored in accordance with the respective provisions of Chapters VI and VII of the First Schedule;

(e) it must be transported in accordance with Chapter VIII of the First Schedule;

(f) it must, during transportation, other than in cases of trade between approved establishments, be accompanied by:

(i) a commercial document which must:

(I) be drawn up by the dispatching establishment,

(II) bear the veterinary approval number of the establishment and in the case of deep-frozen minced meat, clearly show the month and year of freezing,

(III) be kept by the consignee for at least one year so that it can be produced at the request of an authorised officer. In addition, computer data must be printed out at the requested of an authorised officer;

(ii) a health certificate, in the case of minced meat from an establishment situated in a restricted region or area or minced meat to be sent to another Member State, after transit through a third country in a sealed lorry.

6 Other Conditions

6. (1) Minced meat must meet the following requirements in addition to those listed in Regulation 5:

(a) the fresh meat from which it is obtained must:

(i) where it has been frozen or deep-frozen, be obtained from fresh boned meat which has been stored for no longer than 18 months for beef and veal, 12 months for sheepmeat and 6 months for pigmeat, after freezing or deep-freezing, in a cold store approved in accordance with Article 10 of Council Directive 64/433/EEC. However, the Minister may, on application, authorise the boning of pigmeat and sheepmeat on the spot immediately before mincing where he is satisfied that this operation can be carried out in satisfactory conditions of hygiene and quality;

(ii) where it has been chilled, be used:

(I) within no more than 6 days after slaughter of the animals, or

(II) within no more than 15 days after slaughter of the animals in the case of boned, vacuum-packed beef and veal;

(b) the minced meat must have undergone cold treatment in a period of not more than one hour after portioning and wrapping, except where processes requiring the lowering of the internal temperature of the meat during production are used;

(c) the minced meat must be packaged and presented in one of the following forms:

(i) chilled and in this case obtained from meat described in subparagraph (a) (ii) and cooled to an internal temperature below + 2°C in the shortest time possible.

However, the addition of a limited quantity of frozen meat satisfying the conditions laid down in subparagraph (a) (i) shall be authorised to accelerate the refrigeration process provided that this addition is mentioned on the label. In such cases, the period must not exceed one hour.

(ii) deep-frozen, and in this case obtained from meat as described in subparagraph (a) and cooled to an internal temperature below - 18°C as quickly as possible, in accordance with the European Communities (Quick-frozen Foodstuffs) Regulations, 1992 ( S.I. No. 290 of 1992 );

(d) the minced meat must not have been subjected to ionising radiation or ultra-violet treatment;

(e) the designations in Section I of the Second Schedule, possibly combined with the names of the species of animal from which the meat was obtained, may be used on packages only if the requirements set out in Section I of the Second Schedule are met for those designations.

(2) Minced meat to which not more than 1% salt has been added shall be subject to the requirements of this Regulation.

(3) Any addition of additives to the minced meat must comply with the provisions of Council Directive No. 94/36/EC ⁽⁵⁾ of 30 June 1994.

⁽⁵⁾ O.J. No. L237 of 10.9.94, p 13

B. Minced Meat intended for sale on the National Market.

7 Conditions of Registration

7. (1) The Minister may, on application, register an establishment for the production and placing on the market of minced meat intended only for sale within the State provided he is satisfied that the establishment meets the requirements of Chapter I of the First Schedule.

(2) Minced meat produced in establishments registered under paragraph (1) must be prepared in accordance with the requirements of Chapter II of the First Schedule and must comply with the requirements of Regulations 5 and 6 and be obtained from meat as defined in Article 2.2(b). However, minced meat produced in registered establishments may be:

(a) produced, without the necessity of complying with

(i) paragraph 4 of Chapter V of the First Schedule, and

(ii) paragraphs (e) and (f) of Regulation 5 and Regulation 6 other than paragraph (e) as it refers to the first, second and third indents of Section I of the Second Schedule.

(3) Minced meat obtained in accordance with this Regulation must bear the national health mark provided for in Chapter V of the First Schedule and cannot be sent to the territory of another Member State.

Part III Placing on the Market of Meat Preparations

A. Meat Preparations intended for Trade

8 Conditions of approval.

8. (1) The Minister may, on application, approve an establishment for the production of meat preparations intended for trade provided he is satisfied it meets the requirements of Chapter III of the First Schedule, and the requirements of Regulation 9.

(2) Where approval is sought under these Regulations for a plant which forms an integral part of an establishment already approved by the Minister under Council Directives 64/433/EEC, the European Communities (Fresh Poultry meat) Regulations, 1996 ( S.I. No. 3 of 1996 ), the European Communities (Meat Products and Other Products of Animal Origin Regulations, 1995 (S.I. 126 of 1995) or the European Communities (Wild Game) Regulations, 1995 (S.I. No. 298 for 1995), the Minister may allow the premises, equipment and installations for staff and, generally all 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) The Minister may for the purpose of approval, grant manufacturing plants manufacturing meat preparations without an industrial structure or production capacity derogations from the requirements of Chapter III of the First Schedule and from those of Chapter I of the Second Schedule to the European Communities (Meat Products and Other Products of Animal Origin) Regulations, 1995 (S.I. 126 of 1995) and of Chapter I(2) (a) (as regards taps) and paragraph 11 (lockers may be substituted for changing rooms) of Annex A to Directive 64/433/EEC.

Moreover, the Minister may grant derogations from point 1 of Chapter I of the Second Schedule of the European Communities (Meat Products and Other Products of Animal Origin) Regulations, 1995 (S.I. 126 of 1995) as regards rooms where the raw materials and finished products are stored. However, in this case, the Minister must be satisfied that the plant has at least -

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

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

(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.

9 Conditions for Placing on the Market

9. (1) Meat preparations 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 preparations and may set conditions for such approval.

(3) Each meat preparation 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 preparations intended for trade must meet the following requirements:

(a) they must be prepared from fresh meat, other than meat from solipeds, which:

(i) complies with Article 3 of the Directives referred to in Article 2(2) (b) of the Council Directive;

(ii) in the case of imported meat, complies with Directive 72/462/EEC or Chapter III of the European Communities (Fresh Poultrymeat) Regulations, 1996 ( S.I. No. 3 of 1996 ) and the European Communities (Wild Game) Regulations, 1995 ( S.I. No. 298 of 1995 ) and the requirements of the European Communities (Rabbit Meat and Farmed Game Meat) Regulations 1995 ( S.I. No. 278 of 1995 ) or Chapter 11 of Annex I to Directive 92/118/EEC ⁽⁶⁾ and be inspected, in accordance with the European Communities (Importation of Animals and Animal Products from Third Countries) Regulations, 1994 ( S.I. No. 255 of 1994 ). In the case of fresh meat from pigs, it must have been examined for trichinae in accordance with Article 2 of Council Directive No. 77/96/EEC or have undergone cold treatment as referred to in Annex IV to that Directive;

⁽⁶⁾ O.J. No. L 62 of 15.3.1993, P. 49

(b) they must be prepared in a plant approved by the Minister in accordance with Regulation 8;

(c) they must be obtained from meat which, if it has been deep-frozen, must be used within a maximum period after slaughter of 18 months for beef and veal, 12 months for sheepmeat and goatmeat, poultry meat, rabbit meat and farmed game and 6 months for meat from other species. However, the Minister may, on application, authorise the boning of pigmeat and sheepmeat on the spot immediately before preparation provided he is satisfied that this operation is carried out in satisfactory conditions of hygiene and quality;

(d) they must be packaged and when they are to be placed on the market:

(i) chilled, they must be cooled as quickly as possible to an internal temperature below + 2°C for meat preparations obtained from minced meat, + 7°C for preparations obtained from fresh meat, + 4°C for preparations of poultry meat and + 3°C for preparations containing offal;

(ii) deep-frozen, they must be cooled to an internal temperature below - 18°C as quickly as possible, in accordance with the European Communities (Quick-frozen Food stuffs) Regulations, 1992 ( S.I. No. 290 of 1992 );

(5) Meat preparations must fulfil the following requirements in addition to those laid down in paragraph (4):

(a) they must be prepared in accordance with Chapter IV of the First Schedule;

(b) they must be marked with a Community health mark and labelled in accordance with Chapter V of the First Schedule;

(c) they must be wrapped and packaged in accordance with the requirements of Chapter VI of the First Schedule and stored in accordance with Chapter VII of the First Schedule;

(d) they must be transported in accordance with Chapter VIII of the First Schedule;

(e) they must during transportation, other than in cases of trade between approved establishments, be accompanied, as required by the Council Directive, by

(i) a health certificate which must be kept by the consignee for a period of not less than one year for presentation on request to the competent authority or,

(ii) a commercial document which must:

(I) be drawn up by the despatching establishment,

(II) bear the veterinary approval number of the establishment and in the case of frozen product clearly show the month and year of freezing,

(III) be kept by the consignee for at least two years so that it can be produced at the request of an authorised officer. In addition, computer data must be printed out at the request of an authorised officer, or

(iii) A health certificate, in the case of meat preparations from an establishment situated in a restricted region or area or meat preparations to be sent to another Member State, after transit through a third country in a sealed lorry.

(3) With the exception of fresh sausages and sausage meat, meat preparations obtained from minced meat produced by a continuous process may be traded if they fulfil the requirements of this Regulation. However, meat preparations produced from minced meat which is not part of a continuous process may only be traded if they fulfil the requirements of Regulations 5 and 6.

(4) Meat preparations must not have been subjected to ionizing radiation.

(5) Any addition of additives to the meat preparations must comply with the provisions of Council Directive 94/36/EC.

B. Meat preparations intended for Sale on the National Market

10 Conditions of Registration

10. (1) The Minister may, on application, register an establishment for the production of meat preparations intended only for sale within the State provided he is satisfied that it meets the requirements of Chapter III of the First Schedule.

(2) Meat preparation produced in establishments registered under paragraph (1) must be prepared in accordance with the requirements of Chapter IV of the First Schedule and must comply with the requirements of Regulation 9 and be obtained from meat as defined in Article 2(b). However, the meat preparations produced in registered establishments may be produced, without the necessity of complying with

(i) paragraphs (b) and (d) of Chapter IV of the First Schedule;

(ii) Regulation 9(4)(c) and (d);

(iii) paragraph 4 of Chapter V of the First Schedule;

(iv) Regulation 9(5) (d) and (e) and Regulation 9(6).

(3) Meat preparations obtained in accordance with this Regulation must bear the national health mark provided for in Chapter V of the First Schedule and cannot be sent to the territory of another Member State.

Part IV Conditions relating to all Establishments

11 Health Marking Conditions

11. (1) A person shall not place on the market minced meat or meat preparations unless they bear a health mark in accordance with these Regulations.

(2) The health mark shall accord with the requirements of Chapter V of the First Schedule and be applied in accordance with those provisions.

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

(5) Wrapping and packaging materials bearing the health mark shall be subject to such record and control systems as the authorised officer deems necessary.

12 Responsibilities of the Owner or Person in Charge

12. (1) A person who is for the time being the owner or person in charge of an establishment approved or registered by the Minister, in accordance with these Regulations, shall ensure that, at all stages of production, the provisions of these Regulations are complied with. To that end, the owner or person in charge shall ensure that the following requirements of Article 3 of Council Directive 93/43/EEC ⁽⁷⁾ are complied with

⁽⁷⁾ O.J. No. L175 of 19.7.1993, P.2.

— the preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply of foodstuffs must be carried out in a hygienic way.

— steps in their activities critical to ensuring food safety and ensuring adequate safety procedures must be identified, implemented, maintained and reviewed using a HACCP (Hazard Analysis and Critical Control Points) system based on the following principles:

(a) analysing the potential food hazards in a food business operation.

(b) identifying the points in those operations where food hazards may occur.

(c) deciding which of the points identified are critical to food safety — the "critical points".

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

In addition, the owner or person in charge must constantly carry out their own checks in compliance with the following principles:

(a) checking the raw materials entering the establishment to ensure compliance with the criteria set down in the Second and Third Schedules in respect of the final product; and

(b) checking cleaning and disinfection methods; and

(c) taking samples for analysis in a laboratory approved by the Minister and

(d) keeping a written or recorded account of the information required under subparagraph (c) with a view to submitting it to the authorised officer. The results of the different checks shall in particular by kept for a period of at least two years, save in the case of chilled products for which this period may be reduced to six months after the use-by date of the products; and

(e) providing guarantees for the Minister as regards the administration of the health marking, particularly the labels bearing the health mark; and

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

(g) in the event of an immediate human health risk, withdrawing from the market the quantity of 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 authorised officer, until, in accordance with a notice issued by him —

(i) it is destroyed, or

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

(iii) as may be directed in the said notice, reprocessed, in an appropriate manner to ensure its safety.

(2) The person who is for the time being the owner or person in charge must ensure that:

(a) microbiological tests are carried out on minced meat as referred to in Regulations 5 and 6 and meat preparations as referred to in Regulation 9 on a daily basis and at least weekly on other minced meat and meat preparations. These tests must be carried out in a laboratory approved by the Minister.

(b) The samples taken for analysis must comprise five units and be representative of daily production. Samples of meat preparations must be taken from deep in the muscle after the skin has been cauterised.

(c) The results of the microbiological checks must be assessed using the criteria for interpretation laid down in the Second and Third Schedules.

(3) The person who is for the time being the owner or person in charge of an establishment must ensure that the packaging of the products bears a clear and legible indication of the temperature at which the products must be transported and stored, as well as the use-by date for deep-frozen products or the minimum conservation date for chilled products.

(4) 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, unless, in the opinion of the authorised officer, such staff already have adequate qualifications attested, by diplomas.

(5) The requirements as regards self-monitoring, including training and implementation, set down in this regulation must be drawn up in conjunction with an authorised officer.

Part V Approval and Registration

13 Granting of Approval or Registration relating to all Establishments

13. (1) The Minister may attach conditions, as he sees fit, to an approval or registration, as the case may be, granted under Regulations 4, 7, 8 and 10, or subsequently, and may amend or revoke a condition attached to the approval or registration, as the case may be, and shall notify the owner or person in charge of the plant concerned in writing of the conditions, amendment or revocation concerned.

(2) The Minister may, if he is not satisfied that the relevant provisions of these Regulations are being complied with in relation to an establishment refuse to approve or register the establishment, as the case may be, and shall notify the owner or person in charge of the establishment 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 the establishment to take the measures required under these Regulations the Minister may either temporarily suspend or revoke, as the case may be, an approval or a registration, as the case may be.

(4) The Minister shall not —

(a) revoke or suspend an approval or registration given under these Regulations, or

(b) refuse to approve or register, as the case may be, an establishment on foot of an application, without—

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

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

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

(5) Where the Minster, suspends or revokes an approval or registration, as the case may be, granted under these Regulations, the establishment shall not place on the market, supply, sell or use minced meat or meat preparations originating from that establishment subsequent to the date of revocation or suspension, as the case may be, except with the approval of the Minister.

(6) Where an approval or registration, as the case may be, granted under these Regulations is suspended or revoked the Minister may issue a notice requiring that plant to cease production from a date specified in that notice.

(7) The Minister may restore approval or registration, as the case may be, if approval or registration has been suspended in accordance with paragraph (6) or (8), in instances where —

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

(b) tests or checks carried out by an authorised officer confirm the safety of the minced meat or meat preparations emanating from the suspended establishment.

(8) Notwithstanding the other provisions of this Regulation, the Minister may where he is satisfied that there is a serious and immediate risk to animal and human health, suspend without notice an approval or registration, as the case may be, granted under these Regulations.

14 Approval and Registration Numbers

14. (1) When the Minister approves an establishment producing minced meat or meat preparations for trade under these Regulations, he shall allocate an approval number to the establishment. When the Minister registers an establishment producing minced meat or meat preparations for sale on the domestic market under these Regulations, he shall allocate a registration number to the establishment. The Minister shall notify the owner or person in charge of the establishment, in writing of the approval or registration, as the case may be, and of the number.

(2) The Minister shall assign to each establishment the approval number of the establishment plant approved in accordance with Directive 64/433/EEC, the European Communities (FreshPoultry meat) Regulations, 1996 ( S.I. No 3 of 1996 ), the European Communities (Meat Products and Other Products of Animal Origin) Regulations, 1995 ( S.I. No. 126 of 1995 ), the European Communities (Wild Game) Regulations 1995 ( S.I. No. 298 of 1995 ) and the European Communities (Rabbit Meat and Farmed Game Meat) Regulations, 1995 ( S.I. No. 278 of 1995 ) with an indication that it has been approved for the production of minced meat or meat preparations, and to each independent establishment an individual approval number.

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

(a) where an establishment is making preparations obtained from or with raw materials covered by more than one of the Directives referred to in paragraph (2);

(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 paragraph (2).

Part VI Powers of Inspection and Supervision

15 Powers of Inspection

15. (1) In these Regulations, "authorised officer" means — a veterinary examiner or other officer of the Minister appointed to be an authorised officer for the purposes of these Regulations,

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

(3) Subject to the provisions of paragraph (1), an authorised officer or experts from the Commission, within the meaning of Article 9 of the Council Directive, may at all times enter an establishment approved or registered, as the case may be, under these Regulations or for which an application for approval or registration, as the case may be, has been received for the purposes of carrying out inspections, checks and supervision as required by these Regulations and the Council Directive.

(4) Subject to the provisions of paragraph (1), an authorised officer may at all times enter an approved or registered establishment or any other premises or place in which he has reasonable grounds for believing that minced meat or meat preparations are being produced, packaged and stored in contravention of these Regulations and the Council Directive.

(5) Subject to the provisions of paragraph (1), an authorised officer shall have at all times free access to all parts of establishments in order to ensure that the provisions of these Regulations and of the Council Directive are being complied with. Where there is doubt as to the origin of the meat, he shall have access to accounting documents which enable the slaughterhouse or establishment of origin of the raw material to be traced and, as regards compliance with the criteria laid down in the Second and Third Schedules, to the results of the self-monitoring provided for in Regulation 12, including the results of checks on raw materials. In the case of computer data, they must be printed out at the request of an authorised officer.

(6) An authorised officer may:

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

(b) have access, inspect, remove or take copies of or extracts from any books, documents, or other records maintained at the establishment for the purposes of checking compliance with these Regulations, and

(c) take samples of any meat, minced meat or meat preparations, which he finds in the course of his inspection,

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

(7) The authorised officer may be helped by an assistant in carrying out his duties under this Regulation in accordance with the Council Directive.

(8) A person who is for the time being the owner or operator of an establishment approved or registered by the Minister under these Regulations shall carry out all reasonable directions issued by an authorised officer for the purposes of these Regulations.

16 Supervision and Checking

16. (1) An authorised officer may analyse the results of the checks provided for in Regulation 12. He may, on the basis of these analyses, conduct further examinations at all stages of production and on the products. In addition, such sampling, as is specified by an authorised officer, must be 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.

(2) The results of the analyses may be set down by an authorised officer in a report, the conclusions and recommendations of which shall be notified to the owner or person in charge of the establishment, who shall be obliged, in a timescale set down by the authorised officer, to rectify the shortcomings noted with a view to improving hygiene.

(3) Where an authorised officer finds, that there is repeated. non-compliance during self-monitoring with the criteria laid down in the Second and Third. Schedules, he may instruct the owner or person in charge of an establishment to carry out an increased number of tests and may seize the labels and marks bearing the health mark referred to in Chapter V of the First Schedule.

(4) If after the expiry of fifteen days, the output from the establishment still fails to meet the standards set down in paragraph (3), the authorised officer shall take all appropriate measures and shall if necessary require products from the establishments in question to undergo heat treatment. If these measures are not adequate, or the owner or person in charge of the establishment does not make good the shortcomings noted by the authorised officer, the Minister shall suspend or if he thinks fit withdraw the establishment's approval.

(5) Where the owner or person in charge fails to carry out any instruction issued by an authorised officer under paragraph (3), fails to comply with the hygiene rules laid down in this Directive or where an authorised officer considers that there is a serious hygiene risk in an establishment or that he is being obstructed in carrying out an adequate health inspection, he may—

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

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

(iii) in the event of repeated shortcomings, an authorised officer may order that the number of checks be increased, and where he deems it necessary, he may remove or suspend the use or application of labels or seals bearing the health mark.

Part VII Protection of Public Health

17 Powers to protect Public and Animal Health

17. (1) Where in relation to any minced meat and meat preparations an authorised officer forms an opinion that there is a risk to public or animal health -

(a ) he may detain any minced meat, meat preparations or the raw materials used for producing these products,

(b ) he may seize any minced meat or meat preparations, or the raw materials used for producing these products, or

(c ) he may serve or cause to be served, on any person who is the owner of the minced meat or meat preparations or an importer, or exporter of such meat or meat preparations or the person who appears to such officer to be in control for the time being of such meat or meat preparations, a notice requiring either the owner, importer, exporter, or person in control for the time being of the minced meat or meat preparations, that such meat or meat preparations —

(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 minced meat or meat preparations 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 minced meat or meat preparations, 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 the minced meat or meat preparations may appeal within 7 days of the seizure of such meat or meat preparations or service of the notice under paragraph (1) to the Judge of the District Court having jurisdiction in the District Court District where such meat or meat preparations 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 minced meat or meat preparations 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 minced meat or meat preparations 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 minced meat or meat preparations 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 minced meat or meat preparations 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 minced meat or meat preparations at such premises or place as he thinks fit in the circumstances of the case.

(b ) In relation to any seized minced meat or meat preparations, 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 meat or meat preparations 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 minced meat or meat preparations referred to in subparagraph (b) shall be paid to the owner of such meat or meat preparations less any expenses incurred in connection with the said disposal.

(10) The costs of disposal or destruction of minced meat or meat preparations 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 such meat or meat preparations 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 minced meat or meat preparations which is being or has been imported into or exported from the State.

Part VIII Improper use of Health Marks, Certificates or Documents

18 ..

18. (1) A person shall not print or cause to be printed, order, import, purchase, sell, offer or expose for sale labels, 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 label, 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 label, certificate or document with the consent in writing of the Minister, or

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

(3) A person shall not make or cause to have made, order, import, purchase, sell, offer or expose for sale any instrument for affixing a health mark in accordance with Regulation 5(c) and 9(2)(b) on 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 label, 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 IX General Provisions

19 Prosecutions

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

20 Offences

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

(2) If any person fraudulently—

(a ) tampers or otherwise interferes with any meat, minced meat or meat preparations so as to procure that any sample of it taken under these Regulations does not correctly represent such meat or meat preparations,

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

that person shall be guilty of an offence.

(3) 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.

(4) 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 be guilty of an offence.

21 Penalties

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 Revocation

22. The European Communities (Minced Meat) Regulations, 1994 ( S.I. No. 215 of 1994 ) are hereby revoked.

FIRST SCHEDULE

CHAPTER I

SPECIAL CONDITIONS FOR THE APPROVAL OF ESTABLISHMENTS PRODUCING MINCED MEAT

1. Production plants, over and above compliance with the general conditions laid down in Annex I, chapters I and III, of Directive 64/433/EEC, shall have at least:

(a ) a room for mincing and wrapping separate from the cutting room and equipped with a recording thermometer or recording telethermometer.

However, the authorised officer may authorise the mincing of meat in the cutting room provided that the mincing is carried out in a specific area that is clearly separate;

(b ) a room for packaging, unless the conditions laid down in point 63 of Chapter XII of Annex I to Directive 64/433/EEC are fulfilled;

(c ) a room or cabinet for storing salt;

(d ) refrigeration equipment enabling the temperatures laid down in these Regulations to be adhered to.

2. Over and above the general conditions laid down in Chapter I of the First Schedule of the European Communities (Meat Products and Other Products of Animal Origin) Regulations, 1995 ( S.I. No. 126 of 1995 ), independent production units shall have at least:

(a ) rooms in accordance with point 1 in Chapter I the Second Schedule of the European Communities (Meat Products and Other Products of Animal Origin) Regulations, 1995 ( S.I. No. 126 of 1995 )

(b) rooms as described in paragraph 1(a) of this Chapter.

3. The rules laid down in Chapter V of Annex I to Directive 64/433/EEC shall apply as regards the hygiene of the staff, premises and equipment in the establishments.

Staff engaged in the manual preparation of minced meat shall also wear masks covering the mouth and nose. An authorised officer may oblige staff to wear smooth, moisture-proof gloves, either for once-only use or capable of being cleaned and disinfected.

CHAPTER II

CONDITIONS FOR THE PRODUCTION OF MINCED MEAT

1. Meat shall be examined before mincing or cutting up in accordance with Regulation 12. All soiled and suspect parts shall be removed and condemned before the meat is minced.

2. Minced meat may not be obtained from scrap cuttings, scrap trimmings or from mechanically recovered meat.

In particular, it may not be prepared from the meat referred to in Article 5 of Directive 64/433/EEC or, from meat from the following parts of bovine animals, pigs, sheep or goats: muscles from the head, with the exception of masseters, and the non-muscular part of the linea alba, carpus and tarsus region and bone scrapings. The muscles of the diaphragm, after the removal of the serosa and the masseters, may be used only after an investigation for cysticercosis has been carried out. The fresh meat shall not contain any bone fragments.

Where the operations carried out from the time when the meat enters the room referred to in Chapter I to the time when the finished product undergoes the chilling or deep freezing process are performed within a maximum period of one hour, the internal temperature of the meat shall be no higher than + 7°C and the temperature of the production premises shall be no higher than + 12°C. The authorised officer may authorise a longer time limit in individual cases where the addition of seasonings or foodstuffs justifies this on technical grounds, provided hygiene rules are not affected by that derogation.

Where the duration of these operations is over one hour or over the period authorised by the authorised officer in accordance with the preceding subparagraph, the fresh meat may not be used until the internal temperature of the meat has been reduced to a maximum of + 4°C.

3. Minced meat may be deep-frozen only once.

4. Immediately after production the minced meat shall be hygienically wrapped and packaged, and cooled to and after packaging, be stored at the temperatures laid down in Regulation 6(1)(c).

CHAPTER III

SPECIAL CONDITIONS FOR THE APPROVAL OF ESTABLISHMENTS PRODUCING MEAT PREPARATIONS

1. Production plants shall at least have premises which meet the requirements of:

(a) Chapters I and III of Annex I to Directive 64/433/EEC, or

(b) Chapters I and III of Annex I to Directive 71/118/EEC, or

(c) Chapters I and IV, point 1, of the First Schedule to the European Communities (Wild Game) Regulations, 1995 ( S.I. No. 298 of 1995 ); as well as having:

(i) a room separate from the cutting room for the production of meat preparations, the addition of other foodstuffs and wrapping, equipped with a recording thermometer or recording telethermometer.

However, an authorised officer may authorise the production of meat preparations in the cutting room provided that the production is carried out in a specific area that is clearly separate. The addition of seasonings to whole poultry carcasses may be authorised in a specific room that is clearly separate from the slaughtering premises.

(ii) a room for packaging, unless the conditions laid down in point 63 of Chapter XII of Annex I to Directive 64/433/EEC or point 74 of Chapter XIV of Annex I to Directive 71/118/EEC or point 5 of Chapter VIII of the First Schedule of the European Communities (Wild Game) Regulations, 1995 ( S.I. No. 298 of 1995 ) are fulfilled;

(iii) a room for storing seasonings and other cleaned foodstuffs ready for use;

(iv) refrigerated rooms for the storage of:

(i) fresh meat as referred to in Regulation 9 (4)(a)

(ii) meat preparations;

(v) refrigeration equipment enabling the temperatures laid down in these Regulations to be adhered to.

2. Independent production units shall meet the requirements of Chapter I of the First Schedule and Chapter 1 of the Second Schedule to the European Communities (Meat Products and Other Porducts of Animal Origin) Regulaitons, 1995 ( S.I. No. 126 of 1995 ).

3. The rules laid down in Chapter V of Annex I to Directive 64/433/EEC or Directive 71/118/EEC or those of Chapter II of the Second Schedule of the European Communities (Wild Game) Regulations, 1995 ( S.I. No. 298 of 1995 ) shall apply by analogy as regards the hygiene of the staff, premises and equipment in the establishments.

Staff engaged in the manual preparation of meat preparations shall also wear masks covering the noses and mouths. The authorised officer may require such staff to wear smooth, moisture-proof gloves, either for once-only use or capable of being cleaned and disinfected.

CHAPTER IV

SPECIAL REQUIREMENTS FOR THE PRODUCTION OF MEAT PREPARATIONS

1. Over and above compliance with the general requirements of Chapter III, and depending on the type of production concerned:

(a) the production of meat preparations shall take place under conditions of temperature control.

(b) meat preparations shall be wrapped in dispatch units in such a way as to obviate any risk of contamination;

(c) meat preparations may be deep-frozen only once and shall be traded within a period not exceeding 18 months;

(d) meat preparations shall, immediately after the production process, be wrapped and packaged in accordance with Chapter VII and, after packaging, be cooled to the relevant temperature laid down in Regulation 9 (4)(d).

CHAPTER V

MARKING AND LABELLING

1. Minced meat and meat preparations must be marked on the wrapping or packaging with a health mark.

2. Only minced meat obtained in accordance with Regulations 4, 5 and 6 and meat preparations obtained in accordance with Regulations 8 and 9 and produced in production plants approved in accordance with Regulation 4 and 8, may be given the Community health mark. The health mark must correspond:

(a) to point 50 of Chapter XI of Annex I to Directive 64/433/EEC for minced meat,

(b) for meat preparations

(i) of fresh meat of slaughter animals or farmed game meat, to point 50 of Chapter XI of Annex I to Directive 64/433/EEC,

(ii) of poultrymeat or small feathered or furred farmed game, to point 66 of Chapter XII of Annex I to Directive 71/118/EEC,

(iii) of killed game, to point 2 of Chapter VII of the European Communities (Wild Game) Regulations, 1995 ( S.I. No. 298 of 1995 ).

3. Where minced meat or meat preparations are produced in an independent production unit, the health mark must include the approval number assigned by the Minister pursuant to Regulation 14.

4. Without prejudice to the European Communities (Labelling, Presentation and Advertising of Foodstuffs) (Amendment) Regulations, 1991 -( S.I. No. 228 of 1991 ), in the case of meat preparations the following information must be visibly and legibly displayed for inspection purposes on the packaging, where it is not clear from the sales description or the list of ingredients in accordance with (S.I. 228 of 1991), the species from which the meat was obtained, and, in the case of a mixture, the percentage of each species and, for packaging not intended for the final consumer, the date of preparation.

With the exception of fresh sausages and sausage meat and meat preparations obtained from minced meat by continuous process, minced meat and meat preparations obtained from minced meat bearing the Community healthmark provided for in this Chapter, the labelling must also display the following words:

- ' percentage of fat under ...'

- 'Collagen: meat protein ratio under ....'.

5. Minced meat and meat preparations obtained in accordance with Regulations 7 and 10 for sale on the domestic matter must be stamped with the national health mark. The health mark shall correspond with the following requirements:

(a) it shall consist of an isometric triangle with 7 cm sides,

(b) there shall be a 2 cm margin at the top of the triangle containing the word "approved",

(c) the lower portion shall contain the appropriate registration number assigned by the Minister pursuant to Regulation 14.

(d) all figures and letters used shall be at least 0.8 cm high.

CHAPTER VI

WRAPPING AND PACKAGING

1. Packaging (for example packing cases, paperboard boxes) must fulfil all the rules of hygiene, and in particular:

- must not alter the organoleptic characteristics of the minced meat or meat preparations,

- must not be capable of transmitting to the minced meat or meat preparations substances harmful to human health,

- must be strong enough to ensure effective protection of the minced meat or meat preparations during transportation and handling.

2. Packaging must not be re-used for minced meat or meat preparations unless it is made of corrosion-resistant materials which are easy to clean and has been previously cleaned and disinfected.

3. Wrapped minced meat or meat preparations must be packaged.

4. However, when wrapping fulfils all the protective conditions of packaging it need not be transparent and colourless and placing in a second container is not necessary provided that the other conditions of point 1 above are fulfilled.

CHAPTER VII

STORAGE

1. Minced meat and meat preparations must be chilled immediately after wrapping and packaging. Minced meat must be stored at the temperatures indicated in Regulation 6 (1)(c) and meat preparations at the temperatures indicated in Regulation 9(4)(d).

2. Minced meat and meat preparations may be deep-frozen only in rooms of the production establishment or independent production unit or in approved cold stores.

3. In cold stores, minced meat and meat preparations may be stored together with other foodstuffs only if it is ensured by means of packaging that the minced meat or meat preparations cannot be affected unfavourably.

CHAPTER VIII

TRANSPORT

1. Minced meat and meat preparations must be dispatched in such a way that during transport they are protected from anything liable to contaminate them or to affect them unfavourably, having regard to the duration and conditions of transport and to the means of transport employed. In particular, vehicles used to transport the minced meat and meat preparations must be equipped in such a way as to ensure that the temperatures laid down in these Regulations are not exceeded during transport and must be equipped with a recording thermometer to record that the latter requirement is fulfilled.

2. The Minister may, by way of derogation from paragraph 1, authorise the transport of meat preparations originating in the establishments referred to in Regulation 8(3) at temperatures higher than those laid down in this Directive from a production plant or independent production unit to nearby retail premises or local communities, provided that the transportation takes not more than one hour.

3. In the case of transit through a third country and where the production plant is situated in an area subject to restrictions for animal health reasons, the means of transport must remain sealed.

SECOND SCHEDULE

COMPOSITION STANDARDS AND MICROBIOLOGICAL STANDARDS

1. COMPOSITION CRITERIA CHECKED ON THE BASIS OF A DAILY AVERAGE

II. MICROBIOLOGICAL CRITERIA

Production plants and independent production units must ensure that, during the checks provided for in Regulation 12(2) and in accordance with the methods of interpretation set out below, minced meat complies with the following criteria:

The results of the microbiological analyses must be interpreted according to:

A. Three categories of contamination for aerobic mesophile bacteria, Escherichia coli, Staphylococcus aureus viz.:

- up to and including the criterion m,

- between the criterion m and the threshold M,

- above the threshold M.

1. The quality of the consignment shall be considered:

(a) satisfactory, where all the values observed are equal to or less than 3 m where a solid medium has been used or 10m where a liquid medium has been used;

(b) acceptable where all the values observed are between:

(i) 3 m and 10 m (= M) in a solid medium;

(ii) 10 m and 30 m ( = M) in a liquid medium;

and where c/n is equal to or less than 2/5 where n = 5 and c = 2.

2. The quality of the consignment shall be considered unsatisfactory:

- in all cases where values in excess of M are observed,

- when c/n is > 2/5.

However, where this latter threshold has been exceeded for aerobic micro-organisms at + 30°C while all the other criteria have been fulfilled, this exceeding of the threshold must be the subject of a further interpretation, in particular in the case of raw products.

In any event, the product must be considered toxic or tainted when contamination reaches the microbic limit value S, which for general purposes is set at 10³m.

In the case of Staphylococcus aureus, the value of S must never be allowed to exceed 5 x 10⁴.

Tolerances related to analytical techniques shall not apply to the values M and S.

B. Two categories for salmonella with no category tolerance permitted:

- 'Absence in': the result is considered satisfactory,

- 'Presence in': the result is considered unsatisfactory.

THIRD SCHEDULE

MICROBIOLOGICAL CRITERIA

Production plants and independent production units must ensure that, during the checks provided for in Regulation 16 and with the methods of interpretation set out in the Second Schedule and below, meat preparations comply with the following criteria:

GIVEN under my Official Seal,

this 7th day of August 1996.

Ivan Yates,

Minister for Agriculture,

Food and Forestry.

EXPLANATORY NOTE

The purpose of these Regulations is to implement Council Directive No. 94/65/EC of 14 December 1994. The Regulations lay down the requirements for the production and marketing of minced meat and meat preparations for human consumption. They set standards of hygiene and operation for premises producing minced meat or meat preparations either for the domestic market or for export to other Member States in the European Union.