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S.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

Type Statutory Instrument
Publication 1996-01-15
Last updated 2010-03-26
State Repealed superseded text
Text As published
Source Irish Statute Book
articles Not indexed

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

Reform history JSON API

( a ) be approved by or on behalf of the Minister and used in such a way that they do not have adverse effects on the equipment, raw materials and products to which these Regulations relate, and

( b ) be in containers which are clearly identifiable and which bear labels with instructions for their use,

and, after being used, be followed by thorough rinsing with potable water.

32 Hygiene in Transporting and Storing Milk.

32. (1) Milk tanks, premises, installations and working equipment may be used for other foodstuffs if, but only if, all appropriate measures are taken to prevent contamination or deterioration of drinking milk or milk-based products.

33 Commission Inspectors.

33. An expert duly appointed by the European Commission for the purposes of Article 17 of the Principal Directive shall be entitled to make on-site checks on registered holdings, approved collection centres, approved processing establishments, approved processing establishments with limited production capacity, approved standardisation centres or approved treatment establishments in so far as this is necessary to ensure the uniform application of the Directives.

34 Non-Milk Constituents.

34. The manufacture of products in which some milk constituents are replaced by ingredients other than milk-based products shall be subject to the hygiene provisions of the Directives and these Regulations.

35 Powers of the Minister.

35. (1) Without prejudice to any specific provision of these Regulations, where it is suspected that the provisions of these Regulations are not being complied with or there is doubt as to whether the milk or milk-based products to which any of those provisions relate are fit for human consumption, the Minister may check or test or cause to have checked or tested the milk or milk-based product and if necessary may—

( a ) detain and, subject to Regulation 36, have destroyed, reprocessed or denatured, such product as the Minister considers appropriate, in order to prevent its transport, storage, sale or consumption, and

( b ) prohibit the continued treatment or production of milk or milk-based products at the place concerned.

^(1) O.J. No. L 395 of 30 December 1989, P.13.

36 Additional Controls.

36. (1) Where in respect of any milk or milk-based product it is suspected that the provisions of these Regulations are not being complied with or there is doubt as to whether it is fit for human consumption, an authorised officer may—

( a ) detain it, and

( b ) by a notice in writing served on the proprietor or person in charge of any holding or centre or establishment concerned require anything specified in the notice to be done in relation to the milk or milk-based product at the expense of that proprietor or person in charge, including, where considered appropriate, its destruction, reprocessing or denaturing

and where the notice under this paragraph requires and specifies something to be done in relation to such milk or milk-based product, then the authorised officer shall retain control over it until the requirements of the notice have been duly complied with.

( a ) in so far as the notice may relate to the sale or consumption of the milk or milk-based product concerned, on receipt of the notice where the authorised officer is of the opinion, and so states in the notice, that there is a doubt about its fitness for human consumption,

( b ) where subparagraph (a) does not apply and no appeal is taken against the notice, on the expiration of the period during which such appeal could have been taken,

( c ) where subparagraph (a) or (b) does not apply and an appeal is taken under paragraph (4) and the notice is confirmed on appeal or the appeal is withdrawn, on the next day following the day on which the notice is so confirmed or the appeal is withdrawn.

An authorised officer may, at any time, revoke a notice served under this Regulation.

37 Appeals Procedure.

37. (1) The proprietor or person in charge of the holding or centre or establishment concerned who is aggrieved by an exercise of power by the Minister under Regulation 35 or a notice under Regulation 36 herein may, not later than the expiration of the period of 14 days beginning on the date of the notice, appeal to a Judge of the District Court against the notice and in determining the appeal the Judge may—

( a ) if satisfied that in the circumstances of the case it is reasonable so to do, confirm the notice with or without modification, or

( b ) cancel the notice.

( b ) the Minister and the authorised officer concerned shall be entitled to be heard and to adduce evidence at the hearing of the appeal brought under this paragraph.

( b ) the Judge determining the appeal under this paragraph may make such order as to the payment of costs in respect of the appeal as that Judge considers appropriate.

38 Imports from Other Member States and Third Countries.

38. A person shall not import into the State any raw milk, heat-treated milk or milk-based products—

( a ) from any other Member State unless they are produced, processed, packaged, marked and labelled in accordance with the provisions of the Principal Directive;

( b ) from any other state unless—

39 Offences.

39. (1) Any person who contravenes a provision of Regulations 6, 18, 19, 20, 21, 22, 25, 38 and 40 shall be guilty of an offence.

( b ) without prejudice to subparagraph (a), any operator or person in charge of a milk treatment establishment, milk processing establishment, or limited capacity milk processing establishment, who applies or causes to be applied a health mark to any milk or milk-based products which are produced otherwise than in accordance with conditions, requirements and principles necessary to qualify for the right to bear the health mark under these Regulations shall be guilty of an offence.

40 Obstruction of Authorised Officers.

40. A person who obstructs or impedes an authorised officer in the exercise of a power or, without reasonable excuse, does not comply with a requirement under these Regulations or who, in purported compliance with such a requirement, gives information to an authorised officer that the said person knows to be false or misleading in a material respect shall be guilty of an offence.

41 Penalties.

41. A person guilty of an offence under these Regulations shall, on summary conviction, be liable to a fine not exceeding £1,500 or to imprisonment for a term not exceeding 12 months or to both such fine and such imprisonment.

42 Proceedings.

42. Notwithstanding section 10 (4), of the Petty Sessions (Ireland) Act, 1851, proceedings for an offence under these Regulations may be instituted at any time within twenty-four months after the date of the offence.

43 Prosecutions.

43. An offence under these Regulations may be prosecuted by the Minister.

44 Fees.

44. (1) There may be charged such fees in respect of inspections carried out by authorised officers under Regulation 7, 8, 9, 13 or 16 or in respect of services performed by the Minister or an officer of the Minister in connection with matters to which these Regulations relate, as the Minister, with the consent of the Minister for Finance, may determine.

45 Revocation of S.I. 124 of 1990.

45. (1) The European Communities (Standards for Heat Treated Milk in Intra-Community Trade) Regulations, 1990 ( S.I. No. 124 of 1990 ), are hereby revoked.

SCHEDULE

Annex to the Regulations

ANNEX A

REQUIREMENTS RELATING TO THE ACCEPTANCE OF RAW MILK AT TREATMENT AND/OR PROCESSING ESTABLISHMENTS

CHAPTER I Animal health requirements for raw milk

1.

Raw milk must originate as follows:

( a ) from cows or buffaloes:

^(1) O.J. No. 121 of 29 July 1964, P.1977.

— officially tuberculosis-free,

— brucellosis-free or officially brucellosis free;

( b ) from sheep and goats:

^(1) O.J. No. L46 of 19 February 1991, P.19.

( c ) Milk and milk-based products must not come from a surveillance zone established under Directive 85/511/EEC^(2), unless the milk has undergone, under the supervision of the Minister, initial pasteurization (71.7°C for 15 seconds) followed by:

^(2) O.J. No L 315 of 26 November 1985, p. 11.

( a ) a second heat treatment resulting in a negative reaction to the peroxidase test; or

( b ) a drying procedure including heating having an effect equivalent to the heat treatment provided for in (a); or

( c ) a second treatment whereby pH is reduced and kept for at least one hour at less than 6.

2.

When different animal species are kept together on the holding, each species must satisfy the health conditions which would be required if it were alone.

3.

If goats are kept together with cows they must undergo a tuberculosis check in accordance with arrangements to be determined in accordance with the procedure laid down in Article 31 of the Principal Directive.

4.

Raw milk must be excluded from treatments, processing, sale and consumption if it:

( a ) is obtained from animals to which substances within the meaning of Directives 81/602/EEC^(1)and 88/146/EEC^(2) have been administered illegally;

^(1) O.J. No L 222 of 7 August 1981, p.32.

^(2) O.J. No L 70 of 16 March 1988, p.16.

( b ) contains residues of substances within the meaning of Article 15 of the Principal Directive and Regulations 31(2) and 31(6) herein which exceed the permitted level.

CHAPTER II Hygiene of the holding

1.

The raw milk must come from holdings which are registered and checked in accordance with Article 13 (1) of the Principal Directive and Regulations 8 and 9 herein. Where buffaloes, sheep and goats are not kept in the open, the premises used must be designed, constructed, maintained and managed in such a way as to ensure:

( a ) good conditions of housing, hygiene, cleanliness and health of the animals; and

( b ) satisfactory hygiene conditions for milking, handling, cooling and storing milk.

2.

Premises where milking is performed or milk is stored, handled or cooled must be so sited and constructed as to avoid all risk of contamination of the milk. They must be easy to clean and disinfect and have at least:

( a ) walls and flooring which are easy to clean in those areas liable to soiling or infection;

( b ) flooring laid in such a way as to facilitate the draining of liquids and satisfactory means of disposing of waste;

( c ) adequate ventilation and lighting;

( d ) an appropriate and sufficient supply of potable water, complying with the parameters laid down in Annexes D and E to Directive 80/778/EEC^(1), for use in milking and in cleaning the equipment and instruments referred to in Chapter III B of this Annex;

^(1) O.J. No L 229 of 30 August 1980, p.11.

( e ) adequate separation from all sources of contamination such as lavatories and dung heaps;

( f ) fittings and equipment which are easy to wash, clean and disinfect.

In addition, premises for the storage of milk must have suitable milk refrigeration equipment, must be protected against vermin and must have adequate separation from any premises where animals are housed.

3.

If a movable milking bail is used, the requirements in point 2 (d) and (f) must be satisfied and in addition the bail must:

( a ) be sited on fresh ground which is free from any accumulation of excreta or other waste matter;

( b ) provide protection for the milk during the whole period in which it is in use;

( c ) be so constructed and finished as to permit the interior surfaces to be kept clean.

4.

Where milk-producing animals are kept untethered in the open, the holding must also have a milking parlour or milking area adequately separated from the housing area.

5.

The isolation of animals which are infected, or suspected of being infected, with any of the diseases referred to in Chapter I.1 or the separation of the animals referred to in Chapter I.3 from the rest of the herd must be possible and effective.

6.

Animals of all species must be kept away from premises and sites where milk is stored, handled or cooled.

CHAPTER III Hygiene in milking, the collection of raw milk and its transport from the production holding to the collection or standardisation centre or to the treatment establishment or processing establishment — Hygiene of staff

A. Hygiene in milking

1.

Milking must be carried out hygienically and under the conditions established by Directive 89/362/EEC.

2.

Immediately after milking, the milk must be placed in a clean place which is so equipped as to avoid adverse effects on the quality of the milk. If the milk is not collected within two hours of milking, it must be cooled to a temperature of 8°C or lower in the case of daily collection or 6°C if collection is not daily. While the milk is being transported to the treatment and/or processing establishment, the temperature of the cooled milk must not exceed 10°C unless the milk has been collected within two hours of milking.

For technological reasons concerning the manufacture of certain milk-based products, the Minister may authorise derogations from the temperatures laid down in the first subparagraph provided the end product meets the standards set out in Chapter II of Annex C.

B. Hygiene of premises, equipment and tools

1.

Equipment and instruments or their surfaces which are intended to come into contact with milk (utensils, containers, tanks, etc., intended for milking, collection or transport) must be made of smooth material which is easy to clean and disinfect, resists corrosion and does not transfer substances to the milk in such quantities as to endanger human health, impair the composition of the milk or adversely affect its organoleptic characteristics.

2.

After use, the utensils used for milking, the mechanical milking equipment and the containers which come into contact with the milk must be cleaned and disinfected. After each journey, or after each series of journeys where there is only a very short space of time between unloading and the following loading, but in any event at least once a day, containers and tanks used for transporting raw milk to the milk collection or standardisation centre or to the milk treatment or processing establishment must be cleaned and disinfected before reuse.

C. Staff hygiene

1.

Absolute cleanliness shall be required of staff. Specifically:

( a ) persons performing milking and handling raw milk must wear suitable clean milking clothes;

( b ) milkers must wash their hands immediately before the milking commences and keep them clean as far as practicable throughout the milking.

For this purpose, near the place of milking, suitable facilities are required to enable persons performing milking or handling raw milk to wash their hands and arms.

2.

The employer shall take all the requisite measures to prevent persons liable to contaminate raw milk from handling it, until there is evidence that such persons can do so without risk of contamination.

Any person performing milking or handling raw milk shall be required to show that there is no medical impediment to such employment. The medical supervision of such a person shall be governed by the national legislation in force in the Member State concerned or in the case of third countries by specific guarantees to be fixed under the procedure laid down in Article 31 of the Principal Directive.

D. Production hygiene

1.

A monitoring system shall be established under the supervision of the Minister to prevent water being added to raw milk. This system shall in particular include regular checks on the freezing point of milk from each production facility, in accordance with the following procedure:

( a ) the raw milk of each holding must be checked regularly by random sampling. Where the milk of a single holding is delivered directly to a treatment or processing establishment, these samples are to be taken either when the milk is collected from the holding, provided that precautions are taken to prevent any fraud during transport, or before unloading at the treatment or processing establishment when the milk is delivered there directly by the farmer.

If the results of a check lead the Minister to suspect that water is being added, the Minister shall take an authentic sample on the holding. An authentic sample is a sample representing the milk of one completely supervised morning or evening milking beginning not less than eleven hours or more than thirteen hours after the previous milking.

Where milk is delivered from several holdings, samples may only be taken when the raw milk enters the treatment or processing establishment or collection or standardisation centre, provided that spot checks are, however, carried out on the holdings.

If the results of a check lead to suspicion that water has been added, samples shall be taken at all holdings which took part in the collection of the raw milk at issue.

If necessary, the Minister shall take authentic samples within the meaning of the second subparagraph above;

( b ) if the results of the check show that water has not been added, the raw milk may be used for producing raw drinking milk, heat-treated milk or milk for the manufacture of milk-based products for human consumption.

2.

The treatment and/or processing establishment shall inform the Minister when the maximum standards fixed for the plate count and somatic cell count have been reached. The Minister shall take the appropriate measures.

3.

If, within three months of notification of the results of the checks referred to in point 1 (a) and of the investigation provided for in Chapter IV.D, and after the standards of Chapter IV have been exceeded, milk from the holding in question does not meet those standards, that holding shall no longer be authorised to supply raw milk until such milk again meets the said standards.

Milk must not be used for human consumption if it contains antibiotic residues in a quantity which, in respect of any one of the substances referred to in Annexes I and III to Regulation (EEC) No 2377/90^(1), exceeds the levels authorised therein; the combined total of residues of antibiotic substances may not exceed a value to be fixed in accordance with the procedure laid down in Article 31 of the Principal Directive.

^(1)OJ No L 224, 18 of August 1990, p.1.

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

For compliance with these standards, a separate test shall be carried out on a representative sample of the raw milk collected from each production holding.

A. Raw cow's milk

Without prejudice to the limits laid down in Annexes I and III to Regulation (EEC) No 2377/90:

1.

Raw cow's milk intended for the production of heat-treated drinking milk, fermented milk, junket, jellied or flavoured milk and cream must meet the following standards:
Plate count 30°C (per ml) ≤ 100,000^(a)
Somatic cell count (per ml) ≤ 400,000^(b)

^(a) Geometric average over a period of two months, with at least two samples a month.

^(b) Geometric average over a period of three months, with at least one sample a month. Where production levels vary considerably according to season, the Minister may apply a different method of calculating results during the low lactation period.

2.

Raw cow's milk for the manufacture of milk-based products other than those referred to in point 1 must meet the following standards:
from 1.1.1994 from 1.1.1998
Plate count 30°C (per ml) ≤ 400,000^(a) ≤ 100,000^(a)
Somatic cell count (per ml) ≤ 500,000^(b) ≤ 400,000^(b)

^(a) Geometric average over a period of two months, with at least two samples a month.

^(b) Geometric average over a period of three months, with at least one sample a month. Where production levels vary considerably according to season, the Minister may apply a different method of calculating results during the low lactation period.

3.

Raw cow's milk intended for direct human consumption and raw cow's milk for the manufacture of products "made with raw milk" whose manufacturing process does not involve any heat-treatment must:

( a ) meet the standards of point 1;

( b ) in addition meet the following standard^(1):

Staphylococcus aureus (per ml):

n =5

m =500

M = 2,000

c =2

B. Raw buffalo milk

Without prejudice to compliance with the limits laid down in Annexes I and III to Regulation (EEC) No 2377/90:

^(1) Where

n = number of sample units comprising the sample;

m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all sample units does not exceed "m";

M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more sample units is "M", or more;

c = number of sample units where the bacteria count may be between "m" and "M", the sample being considered acceptable if the bacteria count of the other sample units is "m" or less.

1.

Raw buffalo milk for the manufacture of milk-based products must meet the following standards:
from 1.1.1994
Plate count 30°C (per ml) ≤ 1,000,000^(a)
Somatic cell count (per ml) ≤ 500.000^(b)

^(a) Geometric average over a period of two months with at least two samples a month.

^(b) Geometric average over a period of three months with at least one sample a month.

The standards for plate count at 30°C and somatic cell count to apply as from 1 January 1998 will be set in accordance with Article 21 of the Principal Directive.

2.

Raw buffalo milk intended for the manufacture of products "made with raw milk" whose manufacturing process does not involve any heat treatment must meet the following requirements:

plate count 30°C (per ml): ≤ 500,000

somatic cell count (per ml): ≤ 400,000

staphylococcus aureus: as for cow's milk.

C. Raw goat's, sheep's and buffalo's milk must meet the following standards:

1.

If it is intended for the manufacture of heat-treated drinking milk or heat-treated milk-based products:
From 1.1.1995 From 1.2.1999
Plate count at 30°C (per ml) ≤ 3,000,000 ≤ 1,500,000^(a)

^(a) without prejudice to the result of the re-examination to be carried out in accordance with Article 21 of the Principal Directive.

2.

If it is intended for the manufacture of products made with raw milk by a process which does not involve any heat treatment:
From 1.1.1995 From 1.1.1999
Plate count at 30°C (per ml) ≤ 1,000,000 ≤ 500,000

D. When the maximum standards laid down in A, B and C are exceeded and when subsequent investigation indicates a potential danger to health, the Minister shall take appropriate measures.

E. Compliance with the standards of A, B and C must be checked by random sampling, either on collection at the production holding or on acceptance of the raw milk at the treatment or processing establishment.

ANNEX B

CHAPTER I General conditions for approval of treatment establishments and processing establishments

Treatment establishments and processing establishments shall have at least:

1.

working areas of sufficient size for work to be carried out under adequate hygienic conditions. Their design and layout shall be such as to preclude contamination of the raw materials and products covered by the Principal Directive and these Regulations.

Production of heat-treated milk or manufacture of milk-based products which might pose a risk of contamination to other products covered by the Principal Directive and these Regulations must be carried out in a clearly separated working area;

2.

in areas where the raw materials are handled, prepared and processed and the products referred to in the Principal Directive and these Regulations manufactured;

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

( b ) walls which have smooth surfaces and are easy to clean, durable and impermeable, covered with a light-coloured coating;

( c ) in premises where exposed, non-packaged raw materials or products are handled, prepared or processed, ceilings or roof linings which are easy to clean;

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

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

( f ) adequate natural or artificial lighting;

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

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

3.

in rooms where the raw materials and the products covered by the Principal Directive and these Regulations are stored, the same conditions as those at 2 (a) to (f), except:

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

—freezing and deep-freezing rooms, where waterproof and rotproof flooring which is easy to clean is sufficient.

In such cases, a sufficiently powerful refrigeration plant to keep the raw materials and products at the temperatures prescribed in the Principal Directive and these Regulations must be available.

The use of wooden walls in the rooms referred to in the second indent of the first subparagraph does not constitute grounds for withdrawing approval provided they were built before 1 January 1993.

The capacity of the storerooms must be adequate to store the raw materials used and the products covered by the Principal Directive and these Regulations;

4.

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

5.

appropriate arrangements for protection against pests;

6.

instruments and working equipment intended to come into direct contact with raw materials and products made of corrosion-resistant material and easy to clean and disinfect;

7.

special watertight, non-corrodible containers in which to put raw materials or products not intended for human consumption. Where such raw materials or products are removed through conduits, these must be so constructed and installed as to avoid any risk of contamination of the other raw materials or products;

8.

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

9.

a waste water disposal system which meets hygiene requirements;

10.

a supply of potable water only, within the meaning of Directive 80/778/EEC. However, the supply of non-potable water is authorised in exceptional cases for steam production, fire-fighting and refrigeration equipment, provided that the pipes installed for this purpose preclude the use of this water for other purposes and present no direct or indirect risk of contamination of the product. Non-potable water pipes must be clearly distinguished from those used for potable water;

11.

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

12.

if the volume of products treated requires regular or permanent presence, an adequately equipped lockable room for the exclusive use of the Minister;

13.

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

14.

a room or cupboard for storing cleaning and maintenance material;

15.

adequate facilities for cleaning and disinfecting tanks used for transporting milk and liquid or powdered milk-based products. However, such facilities are not compulsory if there is a requirement for the means of transport to be cleaned and disinfected in installations officially approved by the Minister.

CHAPTER II General conditions of hygiene in treatment establishments and processing establishments

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

1.

Equipment and instruments used for working on raw materials and products, floors, ceilings or roof linings, walls and partitions, must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for raw materials or products.

2.

No animals may enter rooms in which milk and milk-based products are manufactured and stored. Rodents, insects and any other vermin must be systematically exterminated in the premises or on the equipment. Rodenticides, insecticides, disinfectants and any other potentially toxic substances must be stored in rooms or cupboards which can be locked; their use must not present any risk of contamination of the products.

3.

Working areas, instruments and working equipment must be used only for work on products for which approval has been granted.

However, following authorisation by the Minister, they may be used at the same time or other times for work on other foodstuffs fit for human consumption or other products based on milk for human consumption but intended for use other than human consumption, provided they do not create contamination of the products for which approval has been given.

4.

Potable water, within the meaning of Directive 80/778/EEC, must be used for all purposes. However, by way of exception, non-potable water may be used for the cooling of equipment, steam production and fire-fighting, provided that the pipes installed for the purpose preclude the use of such water for other purposes and present no risk of contamination of the raw materials and products covered by the Principal Directive and these Regulations.

5.

Disinfectants and similar substances must be approved by the Minister and used in such a way that they do not have adverse effects on the machinery, equipment, raw materials and products covered by the Principal Directive and these Regulations.

Their containers must be clearly identifiable and must bear labels with instructions for their use.

Their use must be followed by thorough rinsing of such instruments and working equipment with potable water.

B. General conditions of hygiene applicable to staff

1.

Absolute cleanliness is required of staff. This applies particularly to persons handling exposed, non-packaged raw materials and products covered by the Principal Directive and these Regulations. Specifically:

( a ) staff must wear suitable clean working clothes and clean headgear which completely encloses the hair;

( b ) staff assigned to the handling and preparation of raw materials and products covered by the Principal Directive and these Regulations must be required to wash their hands at least each time work is resumed and/or where contamination has occurred; wounds to the skin must be covered by a waterproof dressing;

( c ) smoking, spitting, eating and drinking in rooms where raw materials and products covered by the Principal Directive and these Regulations are worked on or stored shall be prohibited.

2.

The employer shall take all the requisite measures to prevent persons liable to contaminate the products covered by the Principal Directive and these Regulations from handling them, until there is evidence that such persons can do so without risk of contamination.

When recruited, any person working on and handling the products covered by the Principal Directive and these Regulations shall be required to prove, by a medical certificate, that there is no medical impediments to such employment.

CHAPTER III Special requirements for approval of collection centres

In addition to the general requirements laid down in Chapter I, collection centres must have at least:

( a ) cooling equipment or appropriate means for cooling milk and, if milk is stored at the collection centre, a cold-storage installation;

( b ) if milk is purified at the collection centre, centrifuges or any other apparatus suitable for the physical purification of milk.

CHAPTER IV Special requirements for approval of standardisation centres

In addition to the general requirements laid down in Chapter I, standardisation centres must have at least:

( a ) containers for the cold storage of raw milk, standardisation equipment and containers for the storage of standardised milk;

( b ) centrifuges or any other apparatus suitable for the physical purification of milk.

CHAPTER V Special requirements for the approval of treatment establishments and processing establishments

In addition to the general requirements laid down in Chapter I, treatment establishments and processing establishments must have at least:

( a ) equipment for the mechanical filling and proper automatic sealing of containers which are to be used for packaging heat-treated drinking milk and milk-based products in liquid form, after filling, in so far as such operations are carried out there. This requirement does not apply to churns, tanks and bulk packaging of more than 4 litres.

However, in the case of limited production of liquid milk intended for drinking, the Minister may authorise alternative methods using means of filling and sealing which are not automatic, provided that such methods carry equal assurances with regard to hygiene;

( b ) equipment for the cooling and cold storage of heat-treated milk, liquid milk-based products and, in the cases provided for in Chapters II and IV, raw milk, in so far as such operations are carried out there. Cold stores must be equipped with correctly calibrated temperature-measuring apparatus;

( c ) —in the case of wrapping in disposable containers, an area for the storage of such containers and for storage of the raw materials intended for their manufacture,

—in the case of wrapping in re-usable containers, a special area for their storage and equipment designed to clean and disinfect them mechanically;

( d ) containers for storing raw milk, standardisation equipment and containers for storing standardised milk;

( e ) if appropriate, centrifuges or any other suitable means for physically purifying milk;

( f ) 1. in the case of treatment establishments, heat-treatment equipment approved or authorised by the Minister, fitted with:

—an automatic temperature control,

—a recording thermometer,

—an automatic safety device preventing insufficient heating,

—an adequate safety system preventing the mixture of heat-treated milk with incompletely heated milk,

—an automatic recording device for the safety system referred to in the preceding indent or a procedure for monitoring the system's effectiveness.

However, when approving establishments, the Minister may authorise different equipment with equivalent performance guarantees and equal assurances with regard to hygiene.

2.

in the case of processing establishments, in so far as such operations are carried out there, equipment and methods for heating, thermization or heat treatment, meeting the hygiene requirements;

( g ) equipment for the cooling, wrapping and storage of frozen milk-based products in so far as such operations are carried out there;

( h ) equipment for drying and wrapping powdered milk-based products in so far as such operations are carried out there.

CHAPTER VI Hygiene requirements relating to the premises, equipment and staff of treatment establishments and processing establishments

In addition to the general requirements laid down in Chapter II, establishments must comply with the following conditions:

1.

Cross-contamination between operations by equipment, ventilation or staff must be avoided. If appropriate, and in the light of the risk analysis referred to in Article 14 of the Principal Directive and Regulation 31 herein, rooms intended for production processes shall be divided into wet and dry areas, each having its own operating conditions.

2.

As soon as possible after each journey, or after each series of journeys where there is only a very short space of time between unloading and the following loading, but in any event at least once each working day, containers and tanks used for transporting raw milk to the milk collection or standardisation centre or to the milk treatment or processing establishment must be cleaned and disinfected before reuse.

3.

Equipment, containers and installations which come into contact with milk or milk-based products or other perishable raw materials during production must be cleaned and if necessary disinfected according to a frequency and procedures consistent with the principles referred to in Article 14 (1) of the Principal Directive and Regulation 31 herein.

4.

The treatment premises must be cleaned according to a frequency and procedures consistent with the principles referred to in Article 14 (1) of the Principal Directive and Regulation 31 herein.

5.

For the cleaning of other equipment, containers and installations which come into contact with microbiologically stable milk-based products and with rooms in which such substances are placed, the operator or manager of the establishment shall draw up a cleaning programme based on the risk analysis referred to in Article 14 of the Principal Directive and Regulation 31 herein. This programme must meet the requirement referred to in point 1 of this Chapter and must also ensure that there is no health risk to products covered by the Principal Directive and these Regulations as a result of inadequate cleaning methods.

ANNEX C

CHAPTER I Requirements for the manufacture of heat-treated milk and milk-based products

A. Requirements for the production of heat-treated drinking milk

1.

Heat-treated drinking milk must be obtained from raw milk which complies with the standards laid down in Annex A, Chapter IV.

2.

Upon acceptance at a treatment establishment milk must, unless treated within four hours of acceptance, be cooled to a temperature not exceeding +6°C and maintained at that temperature until heat-treated.

If raw cow's milk is not treated within 36 hours of acceptance, a further test must be carried out on that milk before it is heat-treated. If it is found by means of a direct or indirect method that the plate count of that milk at 30°C exceeds 300,000 per ml the milk in question must not be used for the production of heat-treated drinking milk.

3.

The manufacture of heat-treated drinking milk shall include all necessary measures, in particular random sampling checks, relating to:

( a ) the plate count, to ensure that:

—raw milk, if it is not treated within 36 hours of acceptance, does not exceed immediately before heat treatment a plate count at 30°C of 300,000 per ml in the case of cow's milk;

—milk which has been subjected to a previous pasteurisation has, immediately before the second heat-treatment, a plate count at 30°C not exceeding 100,000 per ml;

( b ) the presence of extraneous water in the milk

Heat-treated drinking milk shall be subjected to regular checks for the presence of extraneous water, in particular by verification of the freezing point. For this purpose a control system shall be established under the supervision of the Minister. When extraneous water is detected the Minister shall take appropriate measures.

In establishing a control system the Minister shall take account of;

—the results of the checks on raw milk referred to in Annex A, Chapter III D.1, and in particular their variation and average,

—the effect of storage and processing of milk under Good Manufacturing Practices (GMP) on the freezing point.

Heat-treated drinking milk may be subjected to any test which gives an indication of the microbiological condition of the milk before heat treatment. The rules for the application of such tests and the criteria to be met in this regard shall be established in accordance with the procedure laid down in Article 31 of the Principal Directive.

4.

(a) Pasteurized milk must:

( b ) UHT milk must:

— have been obtained by applying to the raw milk a continuous flow of heat entailing the application of a high temperature for a short time (not less than + 135°C for not less than a second) - the aim being to destroy all residual spoilage micro-organisms and their spores - using aseptic opaque containers, or containers made opaque by the packaging, but so that the chemical, physical and organoleptic changes are minimal,

— be of preservability such that no deterioration can be observed by means of random sampling checks after it has spent 15 days in a closed container at a temperature of +30°C; where necessary, provision can also be made for a period of seven days in a closed container at a temperature of +55°C.

Where the "ultra high temperature" milk treatment process is employed by direct contact of milk and steam, the steam must be obtained from potable water and must not leave deposits of foreign matter in the milk or affect it adversely. Moreover, the use of this process must not cause any change in the water content of the treated milk.

( c ) Sterilized milk must:

— have been heated and sterilized in hermetically sealed wrappings or containers, the seal of which must remain intact,

— in the event of random sampling, be of preservability such that no deterioration can be observed after it has spent 15 days in a closed container at a temperature of +30°C; where necessary, provision can also be made for a period of seven days in a closed container at a temperature of +55°C.

( d ) Pasteurized milk which has been subjected to high-temperature pasteurization, UHT milk and sterilized milk may be produced from raw milk which has undergone thermization or an initial heat treatment in another establishment. In this case the time-temperature set must be lower than or equivalent to pasteurization and the milk must show a positive reaction to the peroxidase test before the second treatment.

Recourse to this practice must be brought to the attention of the Minister. Mention of the first treatment must be made on the document provided for in Regulation 22 (1) (m) and 22 (2) herein.

Pasteurized milk may be produced in the same conditions from raw milk which has undergone only initial thermization.

( e ) Heating processes, the temperatures and duration of heating in respect of pasteurised, UHT and sterilized milk, the types of heating equipment, the flow-diversion valve and the types of temperature controlling and recording devices shall be approved or authorised by the Minister in accordance with Community or international standards.

( f ) The data produced by recording thermometers must be dated and kept for two years so that they can be shown upon request to an authorised officer to inspect the establishment, save in the case of microbiologically perishable products, for which this period may be reduced to two months after the use-by or minimum durability date.

5.

Heat-treated drinking milk must:

( a ) meet the microbiological standards laid down in Chapter II;

( b ) not contain pharmacologically active substances in quantities higher than the limits laid down in Annexes I and III to Regulation (EEC) No 2377/90; the combined total of residues of all antibiotic residues may not exceed a value to be fixed in accordance with the procedure laid down in Regulation (EEC) No 2377/90.

B. Requirements for milk for the manufacture of milk-based products

1.

The operator or manager of the processing establishment must take all necessary steps to ensure that the raw milk is heat treated or used, in the case of products "made with raw milk":

— as soon as possible after acceptance if the milk has not been refrigerated,

— within 36 hours of acceptance if the milk is kept at a temperature not exceeding 6°C,

— within 48 hours of acceptance if the milk is kept at a temperature not exceeding 4°C,

— within 72 hours for buffalo's, sheep's and goat's milk.

However, for technological reasons concerning the manufacture of certain milk-based products, the Minister may authorise the times and temperatures referred to in the above indents to be exceeded.

2.

Heat-treated milk intended for the manufacture of milk-based products must be obtained from raw milk which complies with the standards laid down in Annex A, Chapter IV.

3.

Heat-treated milk must meet the following requirements:

( a ) thermized milk must:

( b ) pasteurized milk must

( c ) UHT milk must have been obtained by applying to the raw milk a continuous flow of heat entailing the application of a high temperature for a short time (not less than +135°C for not less than a second) — the aim being to destroy all residual spoilage micro-organisms and their spores - so that the chemical, physical and organoleptic changes are minimal.

CHAPTER II Microbiological criteria for milk-based products and drinking milk

A. Microbiological criteria for certain milk-based products on removal from the processing establishment

1.

Compulsory criteria: Pathogenic micro-organisms
Type of micro-organism Product Standard (ml, g)^(a)
—Listeria monocytogenes —Cheese, other than hard cheese Absent in 25g^(c) n = 5, c = 0
—Other products Absent in 1g
—Salmonella spp. —All except milk powder Absent in 1g n = 5, c = 0
—Milk powder Absent in 1g n = 10, c = 0

In addition, pathogenic micro-organisms and their toxins must not be present in quantities such as to affect the health of consumers.

( a ) Where:

n = number of sample units comprising the sample;

m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all sample units does not exceed "m";

M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more sample units is "M" or more;

c = number of sample units where the bacteria count may be between "m" and "M" the sample being considered acceptable if the bacteria count of the other sample units is "m" or less.

( b ) Testing not compulsory for sterilized milk and milk-based products where the heat treatment was applied after wrapping or packaging.

( c ) The 25g sample to consist of 5 specimens of 5g taken from different parts of the same product.

If these standards are exceeded, the foodstuffs must be excluded from human consumption and withdrawn from the market in accordance with the fifth and sixth indents of Article 14 (1) of the Principal Directive.

Sampling programmes will be drawn up in the light of the nature of the products and the risk analysis.

2.

Analytical criteria: organisms indicating poor hygiene
Type of micro-organism Product Standard (ml, g) Standard (ml, g)
—Staphylococcus aureus Cheese made from raw milk and from thermized milk m = 1,000 M = 10,000 n=5 c=2 m = 1,000 M = 10,000 n=5 c=2
Soft cheese (made from heat-treated milk) m=100 M = 1,000 n=5 c=2 m=100 M = 1,000 n=5 c=2
Fresh cheese Powdered milk Frozen milk-based products (including ice- cream) [image omitted] m=10 M=100 n=5 c=2
—Escherichia coli Cheese made from raw milk and from thermized milk m = 10,000 M = 100,000 n=5 c=2 m = 10,000 M = 100,000 n=5 c=2
Soft cheese (made from heat-treated milk) m=100 M = 1,000 n=5 c=2 m=100 M = 1,000 n=5 c=2

In all cases where these standards are exceeded there must be a review of the implementation of the methods for monitoring and checking critical points applied in the processing establishment pursuant to Article 14 of the Principal Directive and Regulation 31 herein. The Minister shall be informed of the corrective procedures included in the production monitoring system to prevent any repetition of the occurrence.

In addition, whenever the standard M is exceeded in the case of cheese made from raw milk and from thermized milk and soft cheese, testing must be carried out for the possible presence of strains of enterotoxinogenic S. aureus or E. coli that are presumed to be pathogenic and also, if necessary, the possible presence of staphylococcal toxins in such products by means of methods to be determined in accordance with the procedure laid down in Article 31 of the Principal Directive. If the above-mentioned strains are identified and/or staphylococcal enterotoxins are found, all the batches involved shall be withdrawn from the market. In this case, the Minister shall be informed of the findings, pursuant to the fifth indent of the second subparagraph of Article 14 (1) of the Principal Directive and Regulation 31 (1) (c) herein, and of the action taken to withdraw the suspect batches and the corrective procedures introduced into the production monitoring system.

3.

Indicator organisms: guidelines
Type of micro-organism Product Standard (ml, g)
—Coliforms 30°C Liquid milk-based products m = 0 M = 5 n = 5 c = 2
Butter made from pasteurised milk or cream m = 0 M = 10 n = 5 c = 2
Soft cheese (made from heat-treated milk) m = 10,000 M = 100,000 n = 5 c = 2
Powdered milk-based products m = 0 M = 10 n = 5 c = 2
Frozen milk-based products (including ice- cream) m = 10 M = 100 n = 5 c = 2
—Plate count Liquid heat-treated unfermented milk-based products^(a) m = 50,000 M=100,000 n=5 c = 2
Frozen milk-based products (including ice- cream)^(b) m = 100,000 M = 500,000 n = 5 c = 2

^(a) After incubation at 6°C for five days (plate count at 21°C).

^(b) Plate count at 30°C.

These guidelines should help producers in ensuring proper operation of their establishments and in implementing the system and the procedure for carrying out their own checks on their production.

4.

In addition, milk-based products in liquid or gel form which have undergone UHT treatment or sterilization which are intended for conservation at room temperature must meet the following standards after incubation for 15 days at 30°C:

( a ) plate count at 30°C (per 0.1 ml); £10

( b ) organoleptic test: normal.

B. Microbiological criteria for drinking milk

1.

Raw cow's milk for drinking in that state must meet the following standards after wrapping:

Plate count at 30°C (per ml): £ 50,000^(a)>

— Staphylococcus aureus (per ml)

m = 100, M = 500, n = 5, c = 2

— Salmonella: absent in 25g

n = 5, c = 0

In addition, pathogenic micro-organisms and their toxins must not be present in quantities such as to affect the health of consumers.

2.

In the random sampling checks carried out in the treatment establishment pasteurised milk must meet the following microbiological standards^(1):
Pathogenic micro-organisms: absent in 25g
n = 5, c = O, m = 0, M = 0
Coliforms (per ml): n = 5, c = 1, m = 0, M = 5
After incubation at 6°C for five days
Plate count at 21°C (per ml): n = 5, c = 1, m = 5 x 10 ^4M = 5 x 10 ^5.

^(a)Geometric average over a period of two months, with at least two samples a month.

^(1)Where:

n = number of sample units comprising the sample;

m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all sample units does not exceed "m";

M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more sample units is "M" or more;

c = number of sample units where the bacterial count may be between "m" and "M", the sample still being considered acceptable if the bacterial count of the other sample units is bacteria "m" or less.

3.

In the random sampling checks carried out in the treatment establishment, sterilized milk and UHT milk must meet the following standards after incubation at 30°C for 15 days:
— plate count (30°C): ≤10 (per 0.1 ml)
— organoleptic check: normal
— pharmacologically active substances: not exceeding the limits set in Annexes I and III to Regulation (EEC) No 2377/90.

The combined total of residues of all substances may not exceed a value to be fixed in accordance with the procedure laid down in Regulation (EEC) No 2377/90.

4.

When the maximum standards and compulsory criteria are exceeded and when subsequent investigation indicates a potential danger to health, the Minister shall take appropriate measures.

C. Where necessary detailed rules may be established by the Minister for the application of this Chapter and in particular:

—criteria other than those set out in paragraphs A and B in respect of drinking milk and milk-based products,

—microbiological criteria applicable, under conditions managed and controlled by the operator or manager of the establishment, to the use by date.

CHAPTER III Wrapping and packaging

1.

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

2.

Without prejudice to Directive 89/109/EEC^(1), wrapping and packaging must comply with all the rules of hygiene, and be strong enough to protect effectively the products covered by the Principal Directive and these Regulations.

^(1)O.J. No. L 40, 11 of February 1989, p. 38.

3.

Bottling, filling of containers with heat-treated milk and liquid milk-based products and sealing of containers and of packaging must be carried out automatically.

However, in the case of limited production, the Minister may authorise non-automatic sealing methods provided that these provide equal assurances with regard to hygiene.

4.

Wrapping or packaging may not be reused for the products covered by the Principal Directive and these Regulations, with the exception of certain types of containers which may be reused after thorough cleaning and disinfecting.

Sealing must be carried out in the establishment in which the last heat-treatment of drinking milk and/or milk-based products in liquid form has been carried out, immediately after filling, by means of sealing devices which ensure that the milk is protected from any adverse effects of external origin on its characteristics. The sealing system must be so designed that once the container has been opened, the evidence that it has been opened remains clear and easy to check.

5.

The operator or manager of the establishment must ensure for control purposes that, in addition to the information required by Chapter IV, the following information is visibly and legibly displayed on the packaging of the heat-treated milk and milk-based products in liquid form:

—the nature of the heat-treatment which the milk has undergone,

—an indication, in code or not, whereby the date of the last heat-treatment may be established,

—in the case of pasteurised milk, the temperature at which the product must be stored.

However, these details need not appear on the reusable glass bottles referred to in Article 11 (6) of Directive 79/112/EEC.

6.

Product manufacture and packaging operations may take place in the same room, notwithstanding point 1, if the packaging is as described in 2 and subject to the following conditions:

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

( b ) the wrapping and packaging must have been brought to the treatment or processing establishment in a protective cover in which they were placed immediately after manufacture and which protects them from any damage during transport to the establishment and must have been stored there under hygiene conditions in a room intended for that purpose;

( c ) the rooms for storing the packaging material must be free from dust and vermin and separated from rooms containing substances which might contaminate the products. Packaging must not be placed directly on the floor:

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

( e ) packaging must be brought into the room under hygienic conditions and used without delay. It may not be handled by staff handling unwrapped products;

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

CHAPTER IV Conditions governing health marking and labelling

A. Conditions governing health marking

1.

The products covered by the Principal Directive and these Regulations must carry a health mark. Marking must be carried out during or immediately after manufacture in the establishment, in an easily visible place. The mark shall be legible, indelible and its characters easily distinguishable. The health mark may be applied to the product or to the wrapping, if the product is individually wrapped, or to a label affixed to this wrapping. However, where small products are individually wrapped and then packaged together or where such small individually wrapped portions are supplied to the final consumer, it will suffice for the health mark to be applied to their collective packaging.

2.

Where products marked in accordance with point 1 are subsequently placed in a packaging, the health mark must also be applied to the packaging.

3.

( a ) The health mark must give the following particulars within an oval surround:

— above: in capitals, IRL, followed by the approval number of the establishment,

— below: in capitals, EEC;

— above: in capitals, IRELAND,

— in the centre, the approval number of the establishment,

— below: in capitals, EEC;

— above: in capitals, IRL,

— in the centre: a reference to where the approval number of the establishment is shown,

— below: in capitals, EEC;

In the case of the bottles, packaging and containers referred to in Article 11 (4) and (6) of Directive 79/112/EEC, the health mark may indicate only the initials IRL and the approval number of the establishment;

( b ) the health mark may be applied to the product, wrapping or packaging by an ink stamp or by branding, or it may be printed on or applied to a label;

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

B. Conditions governing labelling

Without prejudice to the provisions of Directive 79/112/EEC, the labelling must clearly show for inspection purposes:

1.

the words "raw milk" for raw milk intended for direct human consumption;

2.

the words "made with raw milk" for milk-based products manufactured from raw milk whose manufacturing process does not include any heat-treatment, including thermization;

3.

for other milk-based products the nature of any heat treatment applied at the end of the manufacturing process;

4.

for milk-based products in which growth of micro-organisms can occur, the use-by or minimum durability date.

CHAPTER V Storage and transport requirements

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