LegalizeS.I. No. 9/1996 - European Communities (Hygienic Production and Placing on The Market of Raw Milk, Heat-Treated Milk and Milk-Based Products) Regulations, 1996
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
6 amending acts · 2010-03-26, S.I. No. 117/2010 - European Communities (Official Control of Foodstuffs) Regulations 2010
S.I. No. 9 of 1996.
EUROPEAN COMMUNITIES (HYGIENIC PRODUCTION AND PLACING ON THE MARKET OF RAW MILK, HEAT-TREATED MILK AND MILK-BASED PRODUCTS) REGULATIONS, 1996.
ARRANGEMENT OF PARAGRAPHS
Paragraph
5. Powers of Authorised Officers.
11. Revocation of Registration of Holdings.
12. Register of Treatment and Processing Establishments.
13. Approval of Treatment and Processing Establishments.
14. Health Mark/Approval Number.
19. Raw Milk for Human Consumption.
20. Standards for Raw Milk for use in Heat-Treated Milk or Milk-Based Products.
21. Use of Milk which does not meet the requirements of Chapter IV of Annex A.
22. Standards for Heat-Treated Drinking Milk.
25. Standards for Milk-Based Products.
30. Approval of Limited Production Establishments.
32. Hygiene in Transporting and Storing Milk.
38. Imports from Other Member States and Third Countries.
40. Obstruction of Authorised Officers.
45. Revocation of S.I. 124 of 1990.
SCHEDULE Annexes to Regulations
ANNEX A
CHAPTER I Animal health requirements for raw milk
CHAPTER II Hygiene of holding
CHAPTER III Hygiene in milking, the collection of raw milk and its
transport from the production holding to the collection or
standardisation centre or the treatment establishment or
processing establishment — Hygiene of staff
CHAPTER IV Standards to be met at the time of collection from the
production holding for acceptance of raw milk at treatment
or processing establishments
ANNEX B
CHAPTER I General conditions for approval of treatment
establishments and processing establishments
CHAPTER II General conditions of hygiene in treatment establishments
and processing establishments
CHAPTER III Special requirements for approval of collection centres
CHAPTER IV Special requirements for approval of standardisation centres
CHAPTER V Special requirements for the approval of treatment
establishments and processing establishments
CHAPTER VI Hygiene requirements relating to the premises, equipment
and staff of treatment establishments and processing establishments
ANNEX C
CHAPTER I Requirements for the manufacture of heat-treated milk and milk-based products
CHAPTER II Microbiological criteria for milk-based products and drinking milk
CHAPTER III Wrapping and packaging
CHAPTER IV Conditions governing health marking and labelling
CHAPTER V Storage and transport requirements
CHAPTER VI Health checks and supervision of production
S.I. No. 9 of 1996.
EUROPEAN COMMUNITIES (HYGIENIC PRODUCTION AND PLACING ON THE MARKET OF RAW MILK, HEAT-TREATED MILK AND MILK-BASED PRODUCTS) 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 purposes of giving effect to Council Directive No. 92/46/EEC of 16 June 1992^1 as amended by Council Directive No. 94/71/EEC of 31 December 1994^2, Council Directive No. 92/47/EEC of 16 June 1992^3 and Commission Directive No. 89/362/EEC of 26 May 1989^4, hereby make the following Regulations:
^1 O.J. No. L 268 of 14 September, 1992, P.1
^2 O.J. No. L 368 of 31 December, 1994, P.33
^3 O.J. No. L 268 of 14 September, 1992, P.33
^4 O.J. No. L 156 of 8 June, 1989, P.30
^1 O.J. No. L 268 of 14 September, 1992, P.1
^2 O.J. No. L 368 of 31 December, 1994, P.33
^3 O.J. No. L 268 of 14 September, 1992, P.33
^4 O.J. No. L 156 of 8 June, 1989, P.30
1 Citation.
1. These Regulations may be cited as the European Communities (Hygienic Production and Placing on the Market of Raw Milk, Heat-Treated Milk and Milk-Based Products) Regulations, 1996.
2 Operative Date.
2. These Regulations shall come into operation on the 15th day of January, 1996.
3 Definitions.
3. (1) In these Regulations—
"Annex A", "Annex B" and "Annex C" mean, respectively, Annex A, Annex B and Annex C set out in the Schedule to these Regulations;
"approval number" means the reference number referred to in Regulation 14 (1) (a) or 16 (2), as appropriate;
"approved collection centre" means a centre registered in the Register of Approved Milk Collection Centres maintained by the Minister under Regulation 15;
"approved processing establishment" means an establishment registered in the Register of Approved Milk Processing Establishments maintained by the Minister under Regulation 12;
"approved processing establishment with limited production capacity" means an establishment registered in the Register of Approved Limited Capacity Milk Processing Establishments maintained by the Minister under Regulation 12;
"approved standardisation centre" means a centre registered in the Register of Approved Milk Standardisation Centres maintained by the Minister under Regulation 15;
"approved treatment establishment" means an establishment registered in the Register of Approved Milk Treatment Establishments maintained by the Minister under Regulation 12;
"authorised officer" means a person authorised in writing by the Minister under Regulation 4 to exercise for the purposes of these Regulations and the Directives some or all of the functions conferred on an authorised officer by these Regulations in so far as those functions comprise the designated functions of the particular authorised officer;
"the Directives" means Council Directive No. 92/46/EEC of 16 June 1992 as amended by Council Directive 94/71/EEC of 31 December 1994, Council Directive No. 92/47/EEC of 16 June 1992 and Commission Directive No. 89/362/EEC of 26 May 1989;
"the Principal Directive" means Council Directive No. 92/46/EEC of 16 June 1992;
"functions" includes powers and duties;
"health mark" means the mark referred to and meeting the conditions specified in paragraph A of Chapter IV A of Annex C, to the Principal Directive;
"inspections" includes, where the context admits, examinations, tests, checks and analyses, and cognate words shall be construed accordingly;
"Member State" means a Member State of the European Community;
"the Minister" means the Minister for Agriculture, Food and Forestry;
"official veterinarian" means a person who is a veterinary surgeon and who is authorised by the Minister to exercise the powers of an official veterinarian for the purposes of Regulations 9 and 10;
"temporarily authorised milk treatment establishment", and "temporarily authorised milk processing establishment" mean respectively, an establishment referred to in Regulation 23 or 26, as the case may be;
"veterinary surgeon" means a person who is registered in the register established under the Veterinary Surgeons Act, 1931 ;
"production holding" means a production unit operated by a single producer and/or producers acting together at which one or more milk-producing cows, ewes, goats or buffaloes are kept;
"registered holding" means a production holding which is registered in the Register of Milk Production Holdings maintained under Regulation 6;
- (2) In these Regulations a reference to any enactment is, save where the context otherwise requires, a reference to that enactment as amended by any other enactment.
- (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 enactment is intended, and
( b ) a reference to a paragraph, subparagraph or clause is to the paragraph, subparagraph or clause of the regulation in which the reference occurs, unless it is indicated that reference to some other regulation or provision is intended.
- (4) A word or expression that is used in these Regulations and is also used in the Directives has, unless the contrary intention appears, the same meaning in these Regulations that it has in the Directives.
4 Authorised Officers.
4. (1) There shall be appointed in writing such and so many officers as the Minister thinks fit to be authorised officers for the purposes of some or all of the provisions of these Regulations.
- (2) A warrant of appointment as an authorised officer stating the designated functions of such authorised officer for the purposes of these Regulations and the Directives shall be issued to every person appointed under this Regulation and when exercising any function conferred on the person as an authorised officer, the authorised officer shall, if requested by a person affected, produce the warrant to that person or, where appropriate, an identity document issued pursuant to section 17 of the Animal Remedies Act, 1993 (No. 23 of 1993), which relates to this Regulation.
- (3) The Minister may at any time terminate an appointment as an authorised officer.
5 Powers of Authorised Officers.
5. (1) An authorised officer may, for the purposes of these Regulations and the Directives—
( a ) at any time enter—
- (i) all parts of any milk production holding, processing establishment, treatment establishment, limited capacity milk processing establishment, collection centre or standardisation centre,
- (ii) all parts of any other premises or other land which are material to the operation of the holding or establishment or centre or where it is proposed to establish such a holding, establishment or centre,
- (iii) any other place in respect of which the officer reasonably suspects that—
- (I) milk for human consumption or for use in milk-based products for human consumption is being produced, or
- (II) milk, heat-treated milk, or any milk-based product is being heat-treated, processed, packaged, standardised, collected or stored,
and there carry out or have carried out such inspection of the premises, equipment, processing systems, production, hygienic practices and records as the officer reasonably considers to be necessary or expedient and to inspect any substance found therein or thereat which the officer reasonably believes to be milk or a milk-based product or any substance used in or in connection with the processing of milk, milk-based products or any other product covered by these Regulations and the Directives and, where appropriate, require it to be kept for such period. and at such place as the officer may specify,
( b ) require any person in or on such premises or other land or at such other place (as appropriate) to give, or arrange to be given, to the officer such information and to produce to the officer such documents or other records, including computerised records within the possession, power or procurement of that person relating to the origin of raw milk, heat-treated milk or milk-based products for the purposes of checking compliance with the Directives and to enable the holding or establishment of origin of the raw material to be traced,
( c ) have access to, inspect and take in the original form or as a copy thereof, as appropriate, any such documents or other records including computerised records as aforesaid, and
( d ) take, without payment, such samples of any substance which the officer reasonably believes to be raw milk, heat-treated milk or a milk-based product or any substance used in or in connection with the processing of milk, milk-based products or any other product covered by the Directives found in or on the premises or other land or at the place and carry out or have carried out on the sample such inspections according with any relevant provisions of the Directive, as the officer considers necessary or expedient.
- (2) In this Regulation "place" includes any vehicle, goods container, wagon, vessel or aircraft situated at the place.
- (3) The provisions of Regulation 40 shall apply in the event of the authorised officer being obstructed in the carrying out of the powers conferred on an authorised officer by this Regulation.
6 Register of Holdings.
6. (1) Persons who acquire milk for the preparation of heat-treated drinking milk or for processing into milk-based products shall maintain a register of the holdings on which such milk is produced. This register shall contain the following information:
( a ) the address of the holding on which the milk is produced;
( b ) the name of the owner or person in charge of the holding;
( c ) a unique number to identify the holding for the purpose of these Regulations;
( d ) the number assigned by the Minister to the herd from which the milk was produced;
( e ) such other relevant information as the Minister may from time to time require to be kept.
- (2) Save with the written permission of the Minister, the register shall be maintained at the establishment at which the records relating to the test results of the milk carried out for compliance with the standards prescribed in Regulation 20 are kept. The Minister may, in response to a request in writing, give written permission for the maintenance of the register at any other location, subject to any conditions the Minister may attach.
- (3) The register shall, at all reasonable times, be made available for inspection by any authorised officer or any European Commission appointee referred to in Regulation 33.
- (4) No holding shall be registered nor, once registered, shall it be removed from the register, save with the approval of the Minister.
- (5) The register of persons who use milk produced on their own holdings for the production of milk based products or to supply raw milk for direct human consumption shall be maintained by the Minister. Such persons shall apply in writing to the Minister for the registration of their holdings in the register and shall supply such information as the Minister may require. The Minister shall deal with such applications in accordance with the provisions of Regulation 7.
7 Registration of Holdings.
7. (1) ( a ) A production holding shall be inspected by an authorised officer before it is registered in order to determine whether or not it meets the requirements set out in Chapter II of Annex A, the general code of hygiene laid down in the Annex to Commission Directive No. 89/362/EEC of 26 May 1989, and the standards laid down in Chapter III of the said Annex A.
( b ) Production holdings already producing milk on or before the date these Regulations come into force shall be deemed to be registered.
- (2) Where as a result of an inspection of a production holding by an authorised officer under these Regulations, the Minister is satisfied that the requirements, code of hygiene and standards referred to in paragraph (1) (a) are being met by the holding, the Minister shall register the holding.
8 Inspection of Holdings.
8. (1) ( a ) Every registered holding shall be subject to regular inspection by an authorised officer, to determine whether or not the requirements and code of hygiene referred to in paragraph (1) of Regulation 7 are being met.
( b ) Where, as a result of an inspection of a production holding, the Minister is not satisfied that the requirements and code referred to in paragraph (1) of Regulation 7 are being met, the Minister shall serve on the proprietor or person in charge of the holding a written notice in accordance with paragraph (2) of the shortcomings found and, except in circumstances to which paragraph (4) applies allow the proprietor or person in charge the period of time specified in the notice in which to rectify the shortcomings.
- (2) Except in circumstances to which paragraph (4) apply, the Minister shall neither withhold consent to the registration of a production holding under this Regulation nor have the registration of any registered holding revoked without first—
( a ) serving, or causing to be served, a notice in writing on the proprietor or person in charge of the holding concerned of the Minister's intention to withhold consent to or to have revoked the registration, as the case may be,
( b ) specifying, or causing to be specified, in the notice referred to in subparagraph (a) the Minister's reasons for the intention to withhold consent or to have the registration revoked, as the case may be, by reference to the shortcomings on the holding for the purposes of the Directives and these Regulations, and
( c ) affording, or causing to be afforded to, the proprietor or person in charge of the holding concerned an opportunity of making representations in writing or having representations made in writing on behalf of the proprietor or person in charge, to the Minister, within a period specified in the notice referred to in subparagraph (a) (being a period of not less than 7 days from the date of receipt of that notice by that proprietor or person in charge), in relation to the proposed withholding of consent or revocation of registration.
- (3) If upon the expiration of the period specified in the notice to which paragraph (1) (b) relates in respect of a production holding, or at any time thereafter, or, if deemed necessary by the Minister, as a result of a further inspection of the holding by an authorised officer, the Minister is satisfied that the holding does not meet the requirements and code referred to in paragraph (1) of Regulation 7, the Minister shall refuse to consent to the registration of the holding or shall have revoked the registration, as the case may be, and that holding shall not be registered unless and until a further application for registration is lodged and the Minister is satisfied that the holding meets the requirements and code referred to in paragraph (1) of Regulation 7.
- (4) Notwithstanding paragraphs (1) to (3) of this Regulation, where, as a result of an inspection carried out by an authorised officer, the Minister is satisfied that the milk being produced on the registered holding poses a serious and immediate or potential danger to public health, the Minister shall revoke the registration of the holding forthwith,
9 Animal Health Checks.
9. (1) Every proprietor or person in charge of a registered milk production holding shall have the milking animals on the holding inspected and certified, at such intervals as the Minister shall specify, by a veterinary surgeon. The certification in question shall be drawn up by the Minister and shall deal with some or all of those aspects of Chapter 1 of Annex A.
- (2) ( a ) Where, as a result of an inspection carried out under paragraph (1), the veterinary surgeon concerned is satisfied that the animal health requirements referred to in that paragraph are being met, the veterinary surgeon shall furnish a signed certificate [in duplicate] to that effect, to the proprietor or person in charge of the holding concerned.
( b ) The proprietor or person in charge of a holding to whom a certificate has been furnished under subparagraph (a) shall—
- (i) retain, for inspection by an authorised officer, one copy of each such certificate so furnished until the results of a subsequent inspection are available;
- (ii) send one copy to the establishment or centre which purchases or takes delivery of the milk, as appropriate.
( c ) Persons who prepare raw milk for direct human consumption or milk-based products from raw milk or heat-treated drinking milk or milk-based products from some or all of the milk produced on their own holdings shall send the certificate referred to in subparagraph (a) to the Minister.
- (3) Where as a result of an inspection carried out under paragraph (1), the veterinary surgeon concerned is not satisfied that the animal health requirements referred to in that paragraph are being met, the veterinary surgeon shall notify in writing the proprietor or person in charge of the holding concerned that milk from that holding must not be used in or supplied for the preparation of heat-treated drinking milk or milk-based products for human consumption and shall notify, in writing, the Minister of the position. The notification shall be sent to such office of the Department as the Minister may from time to time direct.
- (4) Inspections carried out in accordance with this Regulation and the Directives may take place on the occasion of veterinary checks carried out pursuant to other Community or National provisions.
- (5) The Minister shall exercise a supervisory function in relation to the regime outlined in this Regulation for the purposes of determining whether or not the provisions of this Regulation are being complied with.
10 Official Veterinarians.
10. (1) The Minister shall, for the purpose of exercising supervisory functions in respect of subparagraph (5) of Regulation 9 appoint in writing one or more registered veterinary surgeons as the Minister designates to be official veterinarians for this purpose.
- (2) A warrant of appointment as an official veterinarian shall be issued to every person appointed under this Regulation and when exercising any function conferred on the person as an official veterinarian, the official veterinarian shall, if requested by a person affected, produce the warrant to that person or, where appropriate, an identity document issued pursuant to section 17 of the Animal Remedies Act, 1993 , which relates to this Regulation.
- (3) An official veterinarian may at any time inspect milking animals on a milk production holding for the purpose of determining whether or not the provisions of Regulation 9 are being complied with.
11 Revocation of Registration of Holdings.
11. Where the Minister is satisfied following any inspection under Regulation 9 or 10, or other inspections which the Minister may deem necessary that the animal health requirements of Chapter 1 of Annex A are not being complied with on a registered holding, the Minister shall prohibit the sale for human consumption of milk produced on that holding.
12 Register of Treatment and Processing Establishments.
12. (1) The Minister shall establish and maintain or cause to be established and maintained
( a ) a register of all approved milk treatment establishments within the State, to be known as the Register of Approved Milk Treatment Establishments,
( b ) a register of all approved milk processing establishments within the State, to be known as the Register of Approved Milk Processing Establishments, and
( c ) a register of all approved milk processing establishments with limited production capacity within the State as defined in Regulation 30 to be known as the Register of Approved Limited Capacity Milk Processing Establishments
which are approved by the Minister for the purposes of these Regulations and the Directives.
- (2) The Register of Approved Milk Treatment Establishments and the Register of Approved Milk Processing Establishments and the Register of Approved Limited Capacity Milk Processing Establishments shall each contain, as appropriate, the following information:
( a ) the name and address of each approved establishment;
( b ) the name of the proprietor or person in charge of each such establishment, as appropriate, together with the trading name or names of each such establishment;
( c ) the date of registration of each establishment;
( d ) a registration number for each such establishment, as appropriate which number shall also be the approval number for the establishment concerned;
( e ) such other information as the Minister may require to be contained in each such register.
- (3) Any application for registration under this Regulation shall be made to the Minister.
- (4) Each register established under this Regulation may be maintained in a non-legible form that is machine readable.
13 Approval of Treatment and Processing Establishments.
13. (1) The Minister shall, before approving any milk treatment establishment or milk processing establishment or limited capacity milk processing establishment for registration under Regulation 12, require that it be inspected by an authorised officer for the purpose of determining whether or not—
( a ) subject to Regulation 30, the establishment concerned complies with—
- (i) the general conditions for approval set out in Chapter I of Annex B,
- (ii) the special requirements for approval set out in Chapter V of Annex B,
- (iii) the general conditions of hygiene set out in Chapter II of Annex B,
and
( b ) it is operated in accordance with the principles set out in Regulation 31 and the hygiene requirements set out in Chapter VI of Annex B.
- (2) The Minister shall specify the product or products to which the approval relates.
- (3) Where, as a result of an inspection of a milk treatment establishment or a milk processing establishment or a limited capacity milk processing establishment by an authorised officer under these Regulations, the Minister is satisfied that the conditions, requirements and principles referred to in paragraph (1) are not being met by the establishment concerned, the Minister shall refuse to approve the establishment.
- (4) ( a ) Every approved establishment shall be subject to inspection by an authorised officer for the purpose of determining whether or not the conditions, requirements, and principles referred to in paragraph (1) are being met.
( b ) Where as a result of an inspection of an approved establishment, the Minister is not satisfied that the conditions, requirements and principles referred to in paragraph (1) are being met, the Minister, without prejudice to paragraph (8)—
- (i) shall serve on the proprietor or person in charge of the establishment a written notice of the shortcomings found and, except in circumstances to which paragraph (8) applies, allow that proprietor or person in charge the period of time specified in the notice in which to rectify the shortcomings;
- (ii) may act in respect of the use of equipment or premises or any part of premises and take any requisite measures which may go as far as limiting or temporarily suspending production;
- (iii) if the measures provided for in clause (ii) prove insufficient, may temporarily suspend approval, if appropriate, for the type of production in question;
- (5) If the proprietor or person in charge of the establishment concerned does not make good the shortcomings noted within the period fixed by the Minister, the Minister shall revoke the approval of that establishment.
- (6) Except in circumstances to which paragraph (8) applies, the Minister shall neither refuse an application for the approval of an establishment under Regulation 12 nor revoke nor suspend the approval of any establishment without first—
( a ) serving, or causing to be served, a notice in writing on the proprietor or person in charge of the establishment concerned of the Minister's intention to refuse or suspend or revoke the approval, as the case may be,
( b ) specifying, or causing to be specified, in the notice referred to in subparagraph (a) the Minister's reasons for the intended refusal or suspension or revocation as the case may be, by reference to the shortcomings of the establishment for the purposes of the Directives and these Regulations, and
( c ) affording, or causing to be afforded to, the proprietor or person in charge of the establishment concerned an opportunity of making representations in writing or having representations made in writing on behalf of that proprietor or person in charge to the Minister, within a period specified in the notice referred to in subparagraph (a) (being a period of not less than 14 days from the date of receipt of that notice by that proprietor or person in charge), in relation to the proposed refusal, suspension or revocation.
- (7) If upon the expiration of the period specified in the notice to which paragraph (6) relates in respect of an establishment, or any time thereafter, or, if deemed necessary by the Minister, as a result of a further inspection of the establishment by an authorised officer, the Minister is satisfied that the establishment does not meet the conditions, requirements and principles referred to in paragraph (1) the Minister shall refuse to approve the establishment or suspend or revoke approval, as the case may be, and that establishment shall not be approved unless and until the Minister receives a further application for approval and is satisfied that the establishment meets the requirements referred to in paragraph (1).
- (8) Where the Minister considers it necessary for the protection of public health the Minister may withdraw approval with immediate effect and take whatever action may be deemed necessary to prevent further use of the milk for the manufacture of heat-treated milk or milk-based products destined for human consumption.
14 Health Mark/Approval Number.
14. (1) ( a ) The Minister shall assign to each approved treatment establishment and approved processing establishment and approved limited capacity milk processing establishment an individual reference number which, for the purposes of these Regulations, shall also be known as and is referred to as its approval number.
( b ) The approval number assigned under subparagraph (a) shall be incorporated into the health mark to be used by the establishment concerned in labelling its production as provided for by the provisions set out in Chapter IV, point A of Annex C.
- (2) Where the Minister has temporarily suspended approval or has revoked the approval of a treatment establishment or a processing establishment or limited capacity milk processing establishment or has revoked approval for the production of any particular product or products at such an establishment, all seals, unused labels, unused wrapping material, cartons or the like, bearing the health mark of the establishment on all such items relating to the establishment or to the product or products in respect of which approval has been temporarily suspended or has been revoked, as the case may be, shall, as the Minister may decide—
( a ) be deposited in a secure, locked store at the establishment or elsewhere under the sole control of an authorised officer, or
( b ) be handed over by the proprietor or person in charge of the establishment to an authorised officer for safe keeping or for destruction as the Minister may see fit.
15 Register of Centres.
15. (1) The Minister shall establish and maintain or cause to be established and maintained—
( a ) a register of all approved milk collection centres within the State, to be known as the Register of Approved Milk Collection Centres, and
( b ) a register of all approved milk standardisation centres within the State, to be known as the Register of Approved Milk Standardisation Centres,
which are approved by the Minister for the purposes of these Regulations and the Directives.
- (2) The Register of Approved Milk Collection Centres, and the Register of Approved Milk Standardisation Centres shall each contain the following information:
( a ) the address of each approved milk collection centre or approved milk standardisation centre, as appropriate;
( b ) the name of the proprietor or person in charge, of each such centre, as appropriate, together with the trading name or names of each such centre;
( c ) the date of registration for each such approved centre;
( d ) a registration number for each such approved centre, which number shall also be the approval number for the centre concerned;
( e ) such other information as the Minister may require to be contained in each such register.
- (3) Any application for registration under this Regulation shall be made to the Minister.
- (4) Each register established under this Regulation may be maintained in a non--legible form that is machine readable.
16 Approval of Centres.
16. (1) The Minister shall, before approving any milk collection centre or milk standardisation centre for registration under Regulation 15, require that it be inspected by an authorised officer for the purpose of determining whether or not the centre concerned complies with—
- (i) the general conditions for approval set out in Chapter I of Annex B, and
- (ii) in the case of a milk collection centre, the special requirements set out in Chapter III of Annex B, or
- (iii) in the case of a milk standardisation centre, the special requirements set out in Chapter IV of Annex B.
- (2) The Minister shall assign to each approved collection centre and approved standardisation centre an individual reference number which, for the purposes of these Regulations, shall also be known as and is referred to as its approval number.
- (3) Where, as a result of an inspection of a milk collection centre or milk standardisation centre the Minister is satisfied that the conditions and appropriate requirements referred to in paragraph (1) are not being met by the centre concerned, the Minister shall refuse to approve the centre.
- (4) ( a ) Every approved collection centre and every approved standardisation centre shall be subject to inspection by an authorised officer for the purpose of determining whether or not the conditions and appropriate requirements referred to in paragraph (1) are being met.
( b ) Where, as a result of an inspection of a milk collection centre or milk standardisation centre, the Minister is not satisfied that the conditions and appropriate requirements are being met, the Minister, without prejudice to paragraph (8)—
- (i) shall serve on the proprietor or person in charge of the centre a written notice of the shortcomings found and, except in circumstances to which paragraph (8) applies, allow that proprietor or person in charge the period of time specified in the notice in which to rectify the shortcomings;
- (ii) may act in respect of the use of equipment or premises or any part of premises and take any requisite measures which may go as far as requiring the limitation or temporary suspension of operation;
- (iii) if the measures provided for in clause (ii) prove insufficient the Minister may temporarily suspend approval, if appropriate, for the type of operation in question.
- (5) If the proprietor or person in charge of the centre concerned does not make good the shortcomings noted within the period fixed by the Minister, the Minister shall revoke the approval of that centre.
- (6) Except in circumstances to which paragraph (8) applies, the Minister shall neither refuse an application for the approval of a centre under Regulation 15 nor revoke nor suspend the approval of any centre without first—
( a ) serving, or causing to be served, a notice in writing on the proprietor or person in charge of the centre concerned of the Minister's intention to refuse or suspend or revoke the approval, as the case may be,
( b ) specifying, or causing to be specified, in the notice referred to in subparagraph (a) the Minister's reasons for the intended refusal or suspension or revocation as the case may be, by reference to the shortcomings of the centre for the purposes of the Directives and these Regulations, and
( c ) affording, or causing to be afforded to, the proprietor or person in charge of the centre concerned an opportunity of making representations in writing or having representations made in writing on behalf of that proprietor or person in charge to the Minister, within a period specified in the notice referred to in subparagraph (a) (being a period of not less than 14 days from the date of receipt of the notice by that proprietor or person in charge), in relation to the proposed refusal or suspension or revocation.
- (7) If upon the expiration of the period specified in the notice to which paragraph (6) relates in respect of a centre or any time thereafter, or, if deemed necessary by the Minister, as a result of a further inspection of the centre by an authorised officer, the Minister is satisfied that the centre does not meet the conditions and appropriate requirements referred to in paragraph (1) the Minister shall refuse to approve the centre or suspend or revoke approval, as the case may be, and that centre shall not be approved unless and until the Minister receives a further application for approval and is satisfied that the centre meets the conditions and appropriate requirements referred to in paragraph (1).
- (8) Where the Minister considers it necessary for the protection of public health the Minister may withdraw approval granted under this Regulation with immediate effect.
17 Approval of Laboratories.
17. Laboratories may be approved by the Minister for the purposes of carrying out tests required under these Regulations.
18 Records to be kept.
18. The proprietor or person in charge of any approved treatment establishment, approved processing establishment, approved limited capacity milk processing establishment, approved collection centre or approved standardisation centre, shall keep such records in respect of milk purchases and deliveries as the Minister may deem necessary to ensure that the provisions of these Regulations and the Directives are being complied with in relation to—
( a ) the holding on which the milk originated,
( b ) the quality and, as appropriate, composition of raw milk,
( c ) the production, handling, transport, processing and placing on the market of raw and heat-treated milk or milk-based products,
( d ) the animal health certification referred to in Regulation 9.
19 Raw Milk for Human Consumption.
19. (1) Raw milk shall not be placed on the market in that state for human consumption unless it meets the following requirements:
( a ) it has been obtained from animals belonging to a herd which satisfies the requirements specified in Chapter I of Annex A;
( b ) in the case of raw cow's milk it meets the standard laid down for somatic cell count at Chapter IV, paragraph 1, point A of Annex A and the criteria laid down at Chapter II, paragraph 1, point B of Annex C;
( c ) it meets the provisions of subparagraphs (a) and (c) of Regulation 20 (1);
( d ) the words "raw milk" shall be clearly displayed on the container or packaging in which the milk is sold as provided for at Chapter IV, paragraph 1, point B of Annex C.
- (2) Raw milk shall not be placed on the market unless the vendor has obtained the written consent of the Minister for its sale. This consent shall be subject to such conditions as the Minister, in consultation with the Minister for Health, may consider necessary.
- (3) Paragraph 1 (b), (c) & (d) of this Regulation shall not apply to raw milk sold directly on the holding to a consumer by its producer. However, the Minister may draw up detailed rules and conditions governing the production of such milk.
20 Standards for Raw Milk for use in Heat-Treated Milk or Milk-Based Products.
20. (1) Save as provided for by Regulations 23, 26 and 27, raw milk shall not be used for the manufacture of milk-based products or heat-treated milk for human consumption unless—
( a ) it is produced on a registered holding;
( b ) save as provided for by paragraph (2), it is obtained from animals which meet the requirements laid down in Chapter I of Annex A;
( c ) it is produced, transported and stored on a registered holding in accordance with the hygiene requirements set out in Chapter III of Annex A;
( d ) save as provided for by Regulation 21, it meets the standards set out—
- (i) at Chapter IV, paragraph 1, point A of Annex A in the case of cow's milk used for heat-treated drinking milk, or
- (ii) at paragraph 2, point A of the said Chapter IV in the case of cow's milk used for the manufacture of milk-based products, and
- (iii) the relevant provisions of the said Chapter IV in all other cases;
( e ) the requirements relating to antibiotic residues, as set out at Chapter III, paragraph 3, point D of Annex A, are met.
- (2) Milk from healthy animals belonging to herds that do not meet the requirements set out at Chapter I, subparagraphs (a) (i) or (b) (i) of paragraph 1 of Annex A shall not be used in the manufacture of heat-treated milk or for the manufacture of milk-based products unless—
( a ) it is first subjected to heat-treatment by the processor under the supervision of or on behalf of the Minister, and
( b ) in all other respects it satisfies the requirements of this Regulation:
Provided that, in the case of goat's milk or sheep's milk intended for export to another Member State such heat-treatment shall be carried out at the place of milking.
21 Use of Milk which does not meet the requirements of Chapter IV of Annex A.
21. Milk which meets the requirements set out in Regulation 20 other than paragraph (1) (d) thereof shall not be used for the production of heat-treated milk or for the manufacture of milk-based products except in accordance with the provisions of Regulation 24 or 27, as the case requires.
22 Standards for Heat-Treated Drinking Milk.
22. (1) Heat-treated drinking milk shall not be placed on the market for human consumption unless:
( a ) it has been heat-treated at a treatment establishment registered under Regulation 12 except where Regulation 23 applies;
( b ) it has been obtained from raw milk which meets the requirements of Regulation 20 except where Regulation 24 applies;
( c ) it has been obtained from raw milk, purified or filtered, if appropriate, by equipment referred to in Chapter V, paragraph (e) of Annex B;
( d ) in the case of cow's milk, it complies with the definition of "drinking milk" provided for in the second, third or fourth indents of paragraph 1 (b) of Article 3 of Council Regulation No. 1411/71/EEC of 29 June 1971^(1) and the provisions of paragraph 3 of Article 6 of that Regulation;
^(1) O.J. Sp. Edn. 1971 (II), p. 412.
( e ) if appropriate, it has passed through an approved milk collection centre and if appropriate, has been transferred from one tank to another under proper hygiene and distribution conditions;
( f ) if appropriate, it has passed through an approved milk standardisation centre;
( g ) if appropriate, milk intended for the production of sterilised milk and UHT milk may have undergone an initial heat-treatment in an approved heat-treatment establishment;
( h ) it has been obtained from raw milk which complies with the requirements set out in Chapter I, point A of Annex C;
- (i) it has been produced under a production regime which satisfies the requirements set out in Regulation 31, and the provisions relating to health checks and supervision of production set out in Chapter VI of Annex C;
( j ) it meets the microbiological criteria applicable to heat-treated milk set out in Chapter II, point B of Annex C;
( k ) it is
- (i) marked and labelled in accordance with the conditions set out in Chapter IV of Annex C, and
- (ii) wrapped and packaged in accordance with the provisions of Chapter III of Annex C, at an approved treatment establishment where the milk has been subjected to final treatment;
( l ) it has, after treatment, been transported and stored in accordance with the requirements of Chapter V of Annex C;
( m ) it is accompanied during transport, except transport for direct delivery to the final consumer, by a commercial document containing sufficient information for—
- (i) the nature of the heat treatment to which it was subjected to be established, and
- (ii) the name of the national controlling authority responsible for supervising the establishment of origin to be identified; and
( n ) in the case of cow's milk, it is free of added water and has a weight of not less than 1028 grammes per litre, as determined in whole milk at 20°C or the equivalent as determined in totally fat-free milk at 20°C and contains a minimum of 28 grammes of protein per litre, obtained by multiplying the percentage of total nitrogen content of the milk by 6.38, and a fat free dry matter content of not less than 8.5%.
- (2) Every document to which paragraph (1) (m) relates shall be retained by the consignee for at least one year and shall be made available to an authorised officer for inspection, if requested.
23 Production of Heat-Treated Milk from Treatment Establishments that do not comply with all the requirements of Chapters I & V of Annex B.
23. (1) Until the 31st day of December, 1997, the Minister may authorise the production of heat-treated drinking milk at a milk treatment establishment not registered under Regulation 12 by virtue of it not meeting some of the requirements of Chapters I and V of Annex B (in these Regulations referred to as a "temporarily authorised milk treatment establishment") and such milk may be sold for human consumption or for use in the manufacture of any milk-based product for human consumption where—
( a ) the proprietor or person in charge of the temporarily authorised milk treatment establishment obtains the written authorisation of the Minister to undertake the production of heat-treated milk at that establishment;
( b ) it satisfies the requirements of subparagraphs (b) to (j) and (l) to (n) of paragraph (1) of Regulation 22;
( c ) it is wrapped or packaged in accordance with the provisions of Chapter III of Annex C and the wrapping or packaging does not show any mark appearing or purporting to be a health mark as provided for in Chapter IV, point A of Annex C.
- (2) ( a ) An application for authorisation under paragraph (1) shall be accompanied by a work plan and programme indicating the period within which it is intended that the milk treatment establishment will be brought up to the standard required for registration in the Register of Approved Milk Treatment Establishments.
( b ) An authorisation under paragraph (1) as a temporarily authorised milk treatment establishment shall be subject to such conditions as the Minister thinks fit to impose, either at the date of authorisation or subsequently.
- (3) Heat-treated drinking milk produced on or after the coming into force of these Regulations at a temporarily authorised milk treatment establishment or any food product in the manufacture of which such milk is used shall not be exported from the State to any other Member State.
- (4) ( a ) Temporarily authorised milk treatment establishments shall be subject to regular inspection by an authorised officer to ensure that the provisions of paragraphs (1) to (3) are being met.
( b ) Where as a result of an inspection by an authorised officer under subparagraph (a), the Minister is not satisfied that the provisions of paragraphs (1) to (3) are being met the Minister may:
- (i) act in respect of the use of equipment, premises or part of a premises and take any requisite measures which may go as far as requiring the limitation or temporary suspension of production;
- (ii) if the measures provided for by clause (i) prove insufficient, the Minister may temporarily suspend the authorisation of the establishment under this Regulation, if appropriate, for the type of production in question;
- (iii) if the establishment is not brought up to the standards required by paragraphs (1) to (3) within the period fixed by the Minister, the Minister shall withdraw authorisation.
- (5) Where the Minister considers it necessary for the protection of public health, the Minister shall withdraw authorisation and suspend production with immediate effect.
- (6) The Minister may require the proprietor or person in charge of any temporarily authorised milk treatment establishment to keep records in respect of milk purchases and usage as the Minister may deem necessary to ensure that the requirements of these Regulations are being met.
24 Production of Heat-Treated Milk from Milk which does not comply with all the requirements of Chapter IV of Annex A.
24. (1) Heat-treated drinking milk produced until 31st day of December, 1997, at an approved milk treatment establishment or at a temporarily authorised milk treatment establishment may be sold and may be supplied for human consumption or for use in the manufacture of any milk-based product for human consumption where—
( a ) the proprietor or person in charge of the establishment at which it is produced—
- (i) has obtained the written authorisation of the Minister to undertake the production of heat-treated milk in accordance with this Regulation, and
- (ii) observes all of the conditions subject to which the authorisation concerned was granted.
( b ) it is made from milk which satisfies the provisions of Regulation 21,
( c ) it satisfies the provisions of subparagraphs (c) to (j) and (l) to (n) of paragraph (1) of Regulation 22,
( d ) it is wrapped or packaged in accordance with the provisions of Chapter III of Annex C and the wrapping or packaging does not show any mark appearing or purporting to be a health mark as provided for in Chapter IV, point A of Annex C.
- (2) Heat-treated drinking milk which is produced in accordance with this Regulation on or after the coming into force of these Regulations and which is permitted to be supplied for human consumption or used in the manufacture of any foodstuff for human consumption shall not be exported from the State to any other Member State.
25 Standards for Milk-Based Products.
25. (1) Save as is provided for by Regulations 26 to 30, milk-based products shall not be placed on the market for human consumption unless—
( a ) they have been manufactured in a processing establishment registered under Regulation 12;
( b ) they have been obtained from—
- (i) raw milk which meets the requirements of Regulation 20 and Chapter I, point B of Annex C and if appropriate, has passed through an approved milk collection centre or an approved milk standardisation centre; or
- (ii) milk intended for the manufacture of milk-based products obtained from raw milk which meets the requirements of clause (i) and comes from an approved treatment establishment and has been stored and transported in accordance with the requirements of Chapter V of Annex C; or
- (iii) other milk-based products which meet the requirements of this Regulation;
( c ) they have undergone heat-treatment during the manufacturing process or are made from products that have undergone heat-treatment or involve hygiene specifications that are sufficient to meet the prescribed hygiene criteria for all finished products;
( d ) they have been produced under a production regime which satisfies the requirements set out in Regulation 31, and the provisions relating to health checks and supervision of production set out in Chapter VI of Annex C;
( e ) save as provided for in Regulations 26 and 27, they are wrapped and packaged in accordance with the provisions of—
- (i) Chapter III of Annex C, and
- (ii) if they are in liquid form and intended for sale to the final consumer, point 3 of the said Chapter III;
( f ) they meet the microbiological criteria for milk-based products laid down in Chapter II of Annex C;
( g ) they have been stored and transported in accordance with Chapter V of Annex C;
( h ) they contain only substances other than milk that are fit for human consumption;
( i ) they have not been subjected to ionizing radiation;
( j ) they have been accompanied during transport, other than transport for direct delivery to the final consumer, by a commercial document containing sufficient information for the nature of the heat treatment to which they were subjected to be established;
( k ) they are marked and labelled in accordance with Chapter IV of Annex C at the registered processing plant where their manufacture was completed.
- (2) The commercial document referred to in paragraph (1) (j) shall indicate the name of the national controlling authority and be retained by the consignee for one year and be made available to an authorised officer if required for inspection.
26 Production of Milk-Based Products from Processing Establishments that do not comply with all the requirements of Chapters I & V of Annex B.
26. (1) Until the 31st day of December, 1997, the Minister may authorise the production of milk-based products at a milk processing establishment not registered under Regulation 12 by virtue of not meeting some of the requirements of Chapters I and V of Annex B (in this Regulation referred to as a "temporarily authorised milk processing establishment") and such products may be sold for human consumption or for use in the manufacture of any other milk-based product for human consumption where—
( a ) the proprietor or person in charge of the temporarily authorised milk processing establishment obtains the written authorisation of the Minister to undertake the production of milk-based products at that establishment;
( b ) they satisfy the requirements of subparagraphs (b) to (d) and (f) to (j) of paragraph (1) of Regulation 25;
( c ) they are wrapped or packaged in accordance with the provisions of Chapter III of Annex C and the wrapping or packaging does not show any mark appearing or purporting to be a health mark as provided for in Chapter IV, point A of Annex C; without prejudice to Council Directive No. 79/112/EEC of 18 December 1978^(1) and Regulations made thereunder, the provisions of Chapter IV, point B of Annex C shall apply.
^(1) O.J. No. L33 of 8 February, 1979, P.1.
- (2) ( a ) An application for authorisation under paragraph (1) shall be accompanied by a work plan and programme indicating the period within which it is intended that the milk processing establishment will be brought up to the standard required for registration in the Register of Approved Milk Processing Establishments.
( b ) An authorisation under paragraph (1) as a temporarily authorised milk processing establishment shall be subject to such conditions as the Minister thinks fit to impose, either at the date of authorisation or subsequently.
- (3) Milk-based products produced at a temporarily authorised establishment shall not be exported from the State to any other Member State.
- (4) ( a ) Temporarily authorised milk processing establishments shall be subject to regular inspection by an authorised officer to ensure that the provisions of paragraphs (1) to (3) are being met.
( b ) Where as a result of an inspection by an authorised officer under subparagraph (a), the Minister is not satisfied that the provisions of paragraphs (1) to (3) are being met the Minister may:
- (i) act in respect of the use of equipment, premises or part of a premises and take any requisite measures which may go as far as requiring the limitation or temporary suspension of production;
- (ii) if the measures provided for by clause (i) prove insufficient, the Minister may temporarily suspend the authorisation under this Regulation, if appropriate, for the type of production in question;
- (iii) if the proprietor or person in charge of the establishment does not bring the establishment to the standards required by paragraphs (1) to (3) within the period fixed by the Minister, the Minister shall withdraw authorisation.
- (5) Where the Minister considers it necessary for the protection of public health, the Minister shall withdraw approval and suspend production with immediate effect.
- (6) The Minister may require the proprietor or person in charge of any temporarily authorised milk processing establishment to keep such records in respect of milk purchases and usage as the Minister may deem necessary to ensure that the requirements of these Regulations are being met.
27 Production of Milk-Based Products from Milk which does not comply with all the requirements of Chapter IV of Annex A.
27. (1) Milk-based products produced until 31st day of December 1997 in accordance with this Regulation may be sold or supplied for human consumption or for use in the manufacture of any foodstuff for human consumption where—
( a ) the proprietor or person in charge of the establishment at which they are produced—
- (i) has obtained the written authorisation of the Minister to undertake the manufacture of dairy products in accordance with this Regulation, and
- (ii) observes all of the conditions subject to which the authorisation concerned was granted.
( b ) they are manufactured in an approved milk processing establishment or in an approved limited capacity milk processing establishment, or in a temporarily authorised milk processing establishment;
( c ) (i) they are made from milk which satisfies the requirements of Regulation 21; or
- (ii) they satisfy the provisions of subparagraphs (b) to (d) and (f) to (j) of paragraph (1) of Regulation 25;
( d ) they meet the requirements of Chapter I, point B of Annex C;
( e ) they are wrapped and packaged in accordance with the provisions of Chapter III of Annex C and the wrapping or packaging does not show any mark purporting or appearing to be a health mark as provided for in Chapter IV, point A of Annex C; without prejudice to Council Directive No. 79/112/EEC of 18 December 1978 and Regulations made thereunder, the provisions of Chapter IV of Annex C shall apply.
- (2) Milk-based products which are produced in accordance with the provisions of this Regulation and which are permitted to be supplied for human consumption shall not be exported from the State to any other Member State.
28 60 Day Cheese.
28. In the case of the manufacture of cheese with a period of ageing or ripening of at least 60 days the Minister may, on foot of a written application and subject to such terms and conditions as the Minister thinks fit, grant exemptions as follows:
( a ) from the requirements of Annex A Chapter IV in respect of the characteristics of the raw milk.
( b ) where the finished product has the characteristics provided for in Chapter II, point A of Annex C—
- (i) from the obligations that the establishment meets the conditions set out in Chapters I and II of Annex B, the requirements set out in Chapters V and VI of Annex B and the requirements set out in Regulation 31; and
- (ii) from the obligation that they be wrapped and packaged in accordance with the provisions of Chapter III of Annex C;
( c ) from the condition governing labelling in Chapter IV, paragraph 2, point B of Annex C.
29 Traditional Products.
29. (1) In the case of the manufacture of milk-based products with traditional characteristics the Minister may grant exemptions from the requirement that—
( a ) the milk meets the requirements set out at subparagraphs (a) and (c) of paragraph (1) of Regulation 20;
( b ) the milk meets the standards set out at—
- (i) Chapter IV, paragraphs 2 and 3, point A of Annex A, in the case of cow's milk;
- (ii) Chapter IV, point B of Annex A, in the case of buffalo milk, and
- (iii) Chapter IV, point C of Annex A, in the case of milk of goat's and sheep milk;
provided the manufacturer of the product has obtained the written permission of the Minister for the use of such milk and abides by any and all the terms and conditions which may be attached to such permission;
- (2) and provided that subject to the permission referred to at paragraph (1), the products manufactured therefrom meet all relevant microbiological criteria set out at Chapter II, point A of Annex C;
- (3) and provided that subject to the permission referred to at paragraph (1), the products are wrapped, packaged, marked and labelled in accordance with the provisions of Chapters III and IV of Annex C.
- (4) For the purposes of the exemption referred to in Paragraph (1), milk-based products with traditional characteristics shall be those products which are;
( a ) recognised historically, or
( b ) manufactured in accordance with technical standards or manufacturing methods codified and registered in the State, or
( c ) recognised or protected as such under national or community law.
30 Approval of Limited Production Establishments.
30. (1) The Minister may, subject to such terms and conditions as the Minister may deem appropriate, and provided that they do not affect the hygienic conditions of production, authorise the registration under Regulation 12 of milk processing establishments which;
( a ) do not meet the conditions and requirements relating to structural standards set out, respectively, in Chapters I and V of Annex B and the requirements in relation to staff training set out in Regulation 31 (7) where—
- (i) the processing capacity of the establishment does not exceed 500,000 litres of milk per year;
- (ii) the premises and equipment are of a suitable hygienic standard and meet the conditions set out at Chapter II of Annex B;
- (iii) the products produced at such premises meet the microbiological criteria set out at Chapter II, point A of Annex C; or
( b ) do not meet the conditions and requirements relating to structural standards set out, respectively, in Chapters I and V of Annex B where—
- (i) the processing capacity of the establishment does not exceed 2,000,000 litres of milk per year;
- (ii) the premises and equipment are of a suitable hygienic standard and meet the conditions set out at Chapter II of Annex B;
- (iii) the products produced at such premises meet the microbiological criteria set out at Chapter II, point A of Annex C.
The establishments referred to at subparagraphs 1 (a) and (b) shall be registered in accordance with Regulation 12 as Approved Limited Capacity Milk Processing Establishments.
- (2) The provisions of paragraphs (3) to (8) of Regulation 13 and Regulation 14 shall apply to establishments falling within the scope of this Regulation.
31 Critical Point Analysis.
31. (1) For the purpose of ensuring that, at all stages of production, the relevant specifications of the Directives and the provisions of these Regulations are complied with, it shall be the responsibility of the proprietor or the person in charge of every milk treatment establishment and milk processing establishment and limited capacity milk processing establishment registered under Regulation 12 and of every temporarily authorised establishment, as provided for in Regulations 23 and 26:
( a ) to conduct or cause to be conducted adequate checks and tests to ensure—
- (i) the identification of critical points in the establishment concerned on the basis of the processes used and the monitoring and checking of such critical points by appropriate methods in order to guard against the contamination of the product in the course of production; the nature of the checks and methods referred to shall be to the satisfaction of the Minister.
- (ii) the taking of samples for analysis in a laboratory approved by the Minister for the purpose of checking cleaning and disinfection methods and for the purpose of checking compliance with the standards established by these Regulations,
and that person shall ensure that sufficient information has been supplied to the Minister or an authorised officer in respect of those checks and tests to enable the Minister to regularly monitor compliance with this subparagraph;
( b ) to keep records of the results and other information on the checks and tests undertaken for the purpose of compliance with subparagraph (a) and to make those results and other information available to authorised officers for inspection or, where directed by the Minister or an authorised officer, to submit them to the Minister or an authorised officer;
( c ) when any laboratory examination or other information at the disposal of the proprietor or person in charge reveals that there is a serious health risk, to submit such information forthwith to the Minister;
( d ) in the event of an immediate human health risk, to withdraw forthwith from the market the quantity of products obtained in technologically similar conditions and likely to present the same risk, and the products so withdrawn shall be held under the supervision and control of the Minister until they are destroyed, used for purposes other than human consumption, or where authorised by the Minister, reprocessed in an appropriate manner to ensure their safety.
- (2) ( a ) Without prejudice to the generality of paragraph (1) (a), the proprietor or person in charge of a milk treatment establishment or milk processing establishment or a limited capacity milk processing establishment or a temporarily authorised establishment shall ensure that in carrying out the checks and tests under paragraph (1) (a), checks and tests are carried out to detect any residues of substances having a pharmacological or hormonal action, and of antibiotics, pesticides, detergents and other substances which, to the extent that those residues exceed the permitted tolerance limits, are harmful or might alter the organoleptic characteristics of milk or milk-based products or make their consumption dangerous or harmful to human health;
( b ) the proprietor or person in charge of a milk treatment establishment or milk processing establishment or a limited capacity milk processing establishment or a temporarily authorised establishment shall ensure that where milk or milk-based products examined show traces of residues which exceed the permitted tolerances they shall be excluded from human consumption.
- (3) The results and information to which paragraph (1) (b) relates shall be maintained for a period of at least two years, except in the case of milk-based products which cannot be stored at ambient temperature, for which the period shall be reduced to two months after the use-by or minimum durability date.
- (4) Subject to compliance with the other relevant provisions of these Regulations an approved milk treatment establishment or an approved milk processing establishment or an approved limited capacity milk processing establishment shall not be operated unless a written undertaking has been given to the Minister by the proprietor or person in charge of the establishment that there will be compliance with the provisions of these Regulations, and with any conditions laid down by the Minister, regarding the use of the health mark.
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