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Regulations 3(5), 6(1)(a), (3)(a), (8) and (9), 9(1)(a) and 19(a), (b) and (e)

SCHEDULE 2CONDITIONS FOR APPROVAL OF DAIRY ESTABLISHMENTS

PART 1GENERAL CONDITIONS OF HYGIENE FOR DAIRY ESTABLISHMENTS.

1.  Dairy establishments shall have the following:

(a)facilities for the hygienic handling and protection of raw materials and of non-packed or non-wrapped dairy products during loading and unloading;

(b)appropriate arrangements for protection against pests;

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

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

(e)appropriate facilities for the cleaning and disinfecting of equipment and instruments;

(f)an adequate waste water disposal system which is hygienic;

(g)a supply of potable water only. However a supply of non-potable water is also permitted provided that it is intended only for the cooling of equipment, steam production, fire-fighting and refrigeration equipment, and 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 dairy products.

(h)an appropriate number of changing rooms with smooth, waterproof, washable walls and floors and within the room or in its immediate vicinity, was basins with non hand-operable taps, hygienic hand-drying facilities and flush lavatories. The lavatories shall not open directly on to the work rooms;

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

(j)a room or cupboard for storing cleaning and maintenance material;

(k)adequate facilities for cleaning and disinfecting tanks used for transporting dairy products. However such facilities shall not be compulsory if alternative facilities which are acceptable to the approving authority are available to the dairy establishment for such purpose; and

(l)rooms with adequate capacity for storing raw materials and dairy products.

2.—(1) Dairy establishments shall have working areas of sufficient size for work to be carried out under adequate hygienic conditions; their design and layout shall be such as to preclude contamination of the raw materials and the dairy products.

(2) The production of heat-treated milk or the manufacture of milk-based products which might pose a risk of contamination to other dairy products shall be carried out in a clearly separated working area.

(3) In areas where raw materials are handled and dairy products are manufactured, the areas shall have the following;

(a)solid, waterproof flooring which is easy to clean and disinfect and which allows water to drain away, and equipment to remove water;

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

(c)ceilings or roof linings which are easy to clean in those areas where exposed or non-packaged raw materials or dairy products are handled;

(d)doors made of 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; taps in work rooms and lavatories for cleaning and disinfecting hands which shall be non hand-operable; these facilities shall be provided with cleaning and disinfecting materials and a hygienic means of drying hands; and

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

3.—(1) Subject to sub-paragraphs (2) and (3) of this paragraph, the rooms where raw materials and dairy products are stored shall comply with the requirements specified in paragraph 2(3)(a) to (f) above.

(2) Raw materials and dairy products may be stored in rooms which do not comply with all or any of the requirements of paragraph 2(3)(a) to (f) above provided that—

(a)in the case of chilling and refrigeration rooms they have a floor which is easy to clean and disinfect and which allows water to drain away; or

(b)in the case of freezing and deep-freezing rooms they have a floor which is waterproof, rotproof and easy to clean; and

(c)in the cases referred to in sub-paragraphs (a) and (b) above, the rooms have a sufficiently powerful refrigeration plant to keep raw materials and dairy products at the temperatures specified by these Regulations.

(3) In freezing and deep-freezing rooms referred to in sub-paragraph (2)(b) of this paragraph, the use of wooden walls shall be permitted provided they were built before 1st January 1993.

PART IISPECIAL CONDITIONS FOR APPROVAL

A. SPECIAL CONDITIONS FOR APPROVAL OF TREATMENT OR PROCESSING ESTABLISHMENTS

1.  In addition to the general requirements laid down in Part I of this Schedule, an establishment shall meet the requirements set out below in this Part.

2.  The establishment shall possess equipment for the mechanical filling and proper automatic sealing of containers (excluding churns, tanks and bulk packaging of more than 4 litres) which are to be used for packaging heat-treated drinking milk and liquid milk-based products, if such operations are carried out at that establishment. However in the case of limited production of liquid milk intended for drinking, alternative non-automatic filling and sealing methods may be used after authorisation by the approving authority provided that such methods carry equal assurance with regard to hygiene.

3.  The establishment shall possess equipment for the cooling and cold storage of heat-treated milk and liquid milk-based products. Where raw milk is stored, purified or standardised at an establishment, that establishment shall also possess equipment for the cooling and cold storage of raw milk. Cold stores shall be equipped with correctly calibrated temperature-measuring apparatus.

4.  The establishment shall possess—

(a)in the case of dairy products wrapped in disposable containers, an area for the storage of such containers and for the storage of raw materials intended for their manufacture; and

(b)in the case of dairy products wrapped in re-usable containers, a special area for their storage, and equipment designed to clean and disinfect them mechanically.

5.  The establishment shall possess containers for storing raw milk and, if appropriate, standardisation equipment and containers for storing standardised milk.

6.  The establishment shall possess centrifuges or any other suitable means for physically purifying milk, if appropriate.

7.—(1) Subject to sub-paragraph (2) below, a treatment establishment shall possess heat-treatment equipment, approved or authorised by the approving authority for the treatment of dairy products, fitted with:

(a)an automatic temperature control;

(b)a recording thermometer;

(c)an automatic safety device preventing insufficient heating;

(d)an adequate safety system preventing the mixture of heat-treated drinking milk with milk which has not been fully heat-treated; and

(e)an automatic recording device which records the operation of the safety system referred to in sub-paragraph (d) above or a procedure for monitoring the system’s effectiveness;

(2) A treatment establishment may have equipment different to those specified in sub-paragraph (1) of this paragraph provided that an equivalent performance may be achieved with equal assurances with regard to hygiene and the approving authority has authorised the use of such equipment.

8.  A processing establishment shall possess equipment for heating, thermisation or heat-treatment if such operations are carried out in that establishment which meets hygiene requirements.

9.  The establishment shall possess equipment for the cooling, wrapping and storage of frozen milk-based products, if such operations are carried out at that establishment.

10.  The establishment shall possess equipment for drying and wrapping powdered milk products, if such operations are carried out at that establishment.

B. SPECIAL CONDITIONS FOR APPROVAL OF A COLLECTION CENTRE

1.  In addition to the general requirements laid down in Part I of this Schedule, a collection centre shall have—

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

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

C. SPECIAL CONDITIONS FOR APPROVAL OF A STANDARDISATION CENTRE

1.  In addition to the general requirements laid down in Part I of this Schedule, a standardisation centre shall have—

(a)containers for the cold storage of raw milk;

(b)standardisation equipment and containers for the storage of standardised milk; and

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

PART IIIGENERAL CONDITIONS OF HYGIENE

A. GENERAL CONDITIONS OF HYGIENE APPLICABLE TO DAIRY ESTABLISHMENTS, INSTRUMENTS AND EQUIPMENT

1.  Rodents, insects and any other vermin shall be systematically destroyed in the dairy establishment and any creature, including any animal of the species referred to in regulation 2(1) shall be prevented from entering rooms in which dairy products are manufactured or stored.

2.  Instruments and equipment used for working on raw materials and dairy products, floors, ceilings or roof linings, walls and partitions shall be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination to raw materials or dairy products.

3.  Rodenticides, insecticides, disinfectants and any other potentially toxic substance shall be stored in lockable rooms or a secure place and used in such a way that they do not have an adverse effect on machinery, equipment, instruments, raw materials or dairy products kept in the dairy establishment.

4.  Working areas, instruments and working equipment shall be used only for work on dairy products in accordance with these Regulations. However, after authorisation by the approving authority, they may be used at the same time or at other times for work on other foodstuffs fit for human consumption, or other milk-based products fit for human consumption but intended for a use other than human consumption provided that they do not contaminate the dairy products for which approval has been given.

5.  Potable water shall be used for all purposes save as permitted by paragraph 1(g) of Part I of this Schedule.

6.  Equipment, containers and installations which come into contact with dairy products or perishable raw materials used during production shall be cleaned and if necessary disinfected according to a cleaning programme based on risk analysis principles.

7.  Other equipment, containers, instruments and installations which come into contact with microbiologically stable dairy products and the rooms in which they are stored shall be cleaned and disinfected according to a cleaning programme based on risk analysis principles drawn up by the occupier of the dairy establishment.

8.  As soon as possible after unloading 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, any container or tank used for transporting raw milk shall be cleaned and disinfected before re-use.

9.  The treatment establishment shall in principle be cleaned according to a cleaning programme based on risk analysis principles.

10.  The occupier of a dairy establishment shall take appropriate measures to avoid cross-contamination of dairy products in accordance with the cleaning programme specified in paragraph 7 above.

11.  Where appropriate, rooms intended for production processes shall be divided into wet and dry areas, each having its own operating conditions.

12.  Disinfectants and similar substances used shall be those acceptable to the approving authority and shall be used in such a way that they do not have any adverse effects on the machinery, equipment, raw materials and dairy products kept at the dairy establishment. They shall be in clearly identifiable containers bearing labels with instructions for their use and their use shall be followed by thorough rinsing of such instruments and working equipment with potable water, except in cases where the disinfectant or similar substance is specifically designed not to be rinsed after application.

13.  Where a dairy establishment produces foodstuffs containing dairy products, together with other ingredients which have not undergone heat-treatment, or other treatment having an equivalent effect, such dairy products and ingredients shall be stored separately to prevent cross-contamination.

B. GENERAL CONDITIONS OF HYGIENE APPLICABLE TO STAFF

1.  The occupier of a dairy establishment shall only employ persons in such an establishment to work directly with and handle raw materials or dairy products if those persons have proved to the occupier’s satisfaction by means of a medical certificate, on recruitment, that there is no medical impediment to their employment in that capacity. This requirement shall not apply to any persons already working in such a capacity before the date on which these Regulations come into force.

2.  Persons working directly with and handling raw materials or dairy products shall maintain the highest standards of personal cleanliness at all times. In particular they shall—

(a)wear suitable, clean working clothes and headgear which completely encloses their hair;

(b)not smoke, spit, eat or drink in rooms where raw materials and dairy products are handled or stored;

(c)wash their hands at least each time work is resumed and whenever contamination of their hands has occurred; and

(d)cover wounds to the skin with a suitable waterproof dressing.

3.  The occupier shall take all necessary measures to prevent persons liable to contaminate raw materials and dairy products from handling them until the occupier has adequate evidence that such persons can do so without risk of contamination.